Central Council For Research in Ayurveda and Sidd

CLINICAL RESEARCH PROTOCOLS
FOR
TRADITIONAL HEALTH SCIENCES
(AYURVEDA, SIDDHA, UNANI, SOWA RIGPA AND OTHERS)
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

Department of AYUSH, Ministry of Health & Family Welfare
Government of India, New Delhi
www.ccras.nic.in
Publisher
Central Council for Research in Ayurveda and Siddha

Department of AYUSH
Ministry of Health and Family Welfare, Government of India
J.L.N.B.C.E.H.Anusandhan Bhavan, 61-65, Institutional Area
Opposite D-Block, Janakpuri, New Delhi – 110058
E-mail: ccras_dir1@nic.in, Website: www.ccras.nic.in
© Central Council for Research in Ayurveda and Siddha, New Delhi

2009
Note: Reproduction/Translation/Citation of any part of this publication are welcome with

due acknowledgement of the Council for academic and research purpose. No citation for
commercial purpose is permitted.
Cover Page Designed by : Dr. N. Srikanth, Assistant Director (Ay.)
Printed at : Pearl Offset Press Pvt. Ltd., 5/33, Kirti Nagar Industrial Area, New Delhi - 110 015
Tel. 011-25159312, 41424700, 41424800
FOREWORD
Ayurveda and Siddha have been in vogue in this country from the earliest times, serving
the medical needs of most of our people. These systems were developed by ancient scholars on
the basis of their own philosophy, oriental methodologies and practices prevalent in that era and
have popularized and almost completed it in all aspects as a system of medicine. The advent of
foreign invasion and cross interaction had definite impact on these systems.
The worldwide interest in the use of natural products and plant-based remedies had led to
different situations developing in different countries. In countries with a strong foundation of
traditional medicine such as India and China, nationally recognized parallel traditional systems have
run for long periods, along with Western medicine with varying degrees of acceptance, integration
and assimilation.
During the last decade, use of traditional medicine has expanded globally and has gained
popularity. It has not only continued to be used for primary health care of the poor in developing
countries, but has also been used in countries where conventional medicine is predominant in the
national health care systems. With the tremendous expansions in the use of Ayurveda and Siddha
world wide, the safety and efficacy as well as quality control of herbal medicines and traditional
procedure-based therapies have become important concerns for both health authorities and the
public. Various practices of traditional medicine have been developed in different cultures in
different regions without a parallel development of international standards and appropriate methods
for evaluating Ayurveda and Siddha systems of Medicine. Like other systems of ancient India
learning Ayurveda was discovered through most suitable sources (Pramanas) viz. (1) Pratyaksha
(direct perception), (2) Anumana (logical inference), (3) Aptopadesa (verbal and authentic
documentary testimony) and (4) Yukti (experimental evidence) etc.
In modern medicine, a clinical trial is almost always undertaken to test the efficacy of
pharmaceutical products (drugs, devices etc.) and some times to study the efficacy of ‘non-
therapeutic interventions’. The global acceptance of modern system of medicine as a whole is
because it has been reviewed systematically by modern scientific parameters. Similar scientific
evidences through clinical trials are the need of time, to make the traditional medical systems
scientifically acceptable by all.
While designing the research trials it would be appropriate to understand differences

between Ayurveda/ Siddha and Contemporary Modern System of Medicine. The differences are
mainly due to the basic approach to Health and Diseases; perception and also epistemological.
The Ayurveda is holistic in approach, in diagnosis, prognosis as well as management of diseases.
Holistic approach of Ayurveda is indeed good and welcome in clinical practice (for the ‘patient’
and the ‘society’). However, this approach has considerable difficulties and even challenges the
III
scientists to devise parameters and design suitable models for clinical studies/trials. The pursuit of
a better understanding of the facts and phenomena in Ayurveda and Siddha, through scientific
research will be able to fill this gap.
Only using the modern scientific tools without considering the holistic concepts of traditional
medical system, may sometimes lead to inappropriate conclusions. This is high time to create the
scientific evidences on Ayurvedic principles and practices taking into the consideration of basic
principles and philosophies embodies in the literature and correlating them with the modern
scientific concepts, which will rightly convey and translate the merits of Ayurveda and other
traditional systems of medicine.
The Central Council for Research in Ayurveda and Siddha has been engaged in scientific
research in Ayurveda and Siddha since more than past three decades and executing research
adopting the integrative protocols. I appreciate the involvement of scholars from various reputed
organizations like Indian Council of Medical Research, All India Institute of Medical Sciences, Lady
Harding Medical College, NIMHANS, Bangalore and other institutes while drafting and finalizing
the protocols.
The views and endorsement of experts from both Ayurveda and Allopathic systems
enriched the protocols providing a good scope of integrative research for creating scientific
evidence.
As research methodology is a continuously evolving subject, one should always consult the
current updates and modify the protocols and formats as per the needs from time to time. This
document would greatly serve as basic reference material for scientists and scholars who are
involved in clinical research in Ayurveda, Siddha and other traditional systems of medicine.
I appreciate the efforts of CCRAS in bringing out this document and would certainly
receive a warm welcome from scientists and scholars engaged in traditional medicine research.
(Dr. C.D. Tripathi)

Professor and Head
Department of Pharmacology
Vardhman Mahavir Medical College
& Safdarjung Hospital
New Delhi
IV
PREFACE
Research is essential for development of any science. This is even more necessary in
respect of ancient sciences like Ayurveda and Siddha. The various schemes and initiatives of
Government of India led to establishment of a National body “Central Council for Research in
Indian Medicine and Homeopathy (CCRIMH) in 1969. The Central Council for Research in
Ayurveda & Siddha was started in 1978 as a successor to CCRIMH, for research in Ayurveda
and Siddha.
The Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry
of Health & Family Welfare, Government of India is an apex Nodal Body in India for the
formulation of Research in Ayurveda and Siddha on scientific lines. The research activities of
CCRAS include Literary Research, Drug Research, Clinical Research including Nutraceuticals
Research, Cosmeceutical Research and Bio-medical instrumentation and Reproductive and Child
Health Care Research. The Council has been carrying out its research activities through the
network of the peripheral institutes across the country and also in collaboration with various
National and International academics and Research Organizations.
The Council is executing research studies on scientific lines as per the prevalent guidelines
with Ayurveda and Siddha related part so as to make it integrative in nature. The Council has
currently undertaken execution of clinical trials on more than 30 priority areas on phased manner
adopting the current norms of drug development process viz. pre-clinical standardization/toxicity
studies and phased clinical trials.
The integrative research protocols and Case Report Forms (CRFs) incorporating basic
principles of Ayurveda and current requirement and methodology of research etc. have been
developed from time to time through extensive consultative process involving high profile experts
in the field of Ayurveda and Allopathic system of medicine from reputed institutes viz. AIIMS,
ICMR, CSIR, NIMHANS and so on.
Dissemination of these methodologies by publishing the formats of selected diseases along
with protocols, Case Report Forms (CRFs) would help the scientists, academicians, PG and
V
Ph.D. scholars etc. who wish to conduct research on different diseases/conditions in developing
protocols and serving as a basic reference material. However, the specific protocol could be
developed by individuals suitable to their needs based on the specific objectives.
There has been a great need for a comprehensive compendium of Protocol formats and
Case Report Forms (CRFs) for ready reference of research scholars, scientists etc. Keeping this
in view the Council is publishing the present compendium and I am convinced that this will be of
immense help not only for researchers more so ever to the Post Graduate and Doctorial
Scholars.
I am highly thankful to Dr. C. D. Tripathi, Professor & Head, Deptt. of Pharmacology,
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi for sparing his valuable
time by offering suitable suggestions that has made this document more authentic and scientific.
I greatly appreciate the scientists of CCRAS, expert members of task force whose efforts
made this work possible. I also appreciate Dr. M.M. Sharma, Dr. B.S. Sharma, Mr. Upendra
Singh & Mr. Narender Singh from publication section for their tireless efforts in bringing out this
publication, Mr. Gaurav Kumar and Mr. Prasanto Choudhary, Data Entry Operators for secretarial
assistance.
New Delhi (Prof. G.S. Lavekar)

Director General
CCRAS
VI
CHIEF EDITOR
Prof. G.S. LAVEKAR

Director General
Central Council for Research in Ayurveda and Siddha, New Delhi
EXPERT REVIEWER
Dr. C.D. TRIPATHI

Professor & Head
Department of Pharmacology
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi
EDITOR
Dr. M.M. PADHI

Deputy Director (Technical)
PROGRAMME COORDINATOR
Dr. N. SRIKANTH
Assistant Director (Ay.)
VII
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VIII
CORE SCIENTIFIC GROUP
Dr. M.M. Rao Dr. Sulochana Bhat

Deputy Director (Ay.) Assistant Director (Ay.)
CCRAS, New Delhi CCRAS, New Delhi
Dr. Sobran Singh Dr. T. Anandan
Assistant Director (Ay.) Assistant Director (Siddha)
CCRAS, New Delhi Central Research Institute (Siddha) Chennai
Dr. Adarsh Kumar Dr. G. Ganapathi Raman
Assistant Director (Ay.) Ex. Asst. Director (Siddha)
Dr. G.C. Bhuyan R.K. Singhal
Research Officer (Ay.) Statistical Officer
Dr. Sarada Ota Dr. M.K. Jha
Research Officer (Ay.) Ex. Research Officer (Medicine)
Dr. Banamali Das Dr. B. Venkateshwarlu
Research Officer (Ay.) Research Officer (Ay.)
Dr. M.M. Sharma Dr. K. Prameela Devi
Research Officer (Ay.), Research Officer (Ay.)
Dr. B.S. Sharma Dr. S.K. Vedi
Research Officer (Ay.), Research Officer (Ay.)
Dr. S.K. Meher Dr. K. Bharati
Research Officer (Ay.), Assistant Director (Ay.)
CCRAS, New Delhi IIHM, Hyderabad
Dr. A.C. Kar Dr. Galib
Ex. Asst. Director (Ay.) Ex. Research Officer (Ay.),
IX
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X
TASK FORCE OF EXPERTS FROM REPUTED
INSTITUTES
All India Institute of Medical Sciences, New Delhi
Dr. M.V. Padma Prof. S.K. Sharma

Additional Professor Head of Department
Department of Neurology Department of Medicine
AIIMS Ansari Nagar AIIMS Ansari Nagar
New delhi-110029 New Delhi – 110029
Prof. Y.K. Gupta Dr. S.C. Mahaptra
Head of Department Professor
Department of Pharmacology Department of Physiology
AIIMS Ansari Nagar AIIMS Ansari Nagar
New Delhi - 110029 New Delhi – 110029
Dr. Nikhil Tandon Dr. Jasbir Kaur
Addl. Professor Endocrinology Asst. Professor
AIIMS New Delhi – 110029 Dr. R.P. Centre for Ophthalmic Sciences
AIIMS New Delhi – 110029
Prof. K.K. Talwar Dr. Monoranjan Mahapatra
Prof.& HOD, Cardiology Assoc. Professor Endocrinology
AIIMS Ansari Nagar AIIMS New Delhi – 110029
New Delhi – 110029
Dr. Suneeta Mittal Prof. Anita Panda
Professor & HOD Dr. R.P. Centre for Ophthalmic Sciences
Department of Obstetrics and Gynaecology AIIMS Ansari Nagar
AIIMS Ansari Nagar New Delhi – 110029
Indian Council for Medical Research, New Delhi

Dr. Neena Valecha Dr. Nandani Kumar
Deputy Director Ex. Deputy Director General
Malaria Research Centre (ICMR) ICMR
New Delhi Ansari Nagar
XI
Dr. Arvind Pandey Dr. Abha Rani Aggarwal
National Institute of Medical Statistics Scientist E
ICMR Head Quarters Campus, Ansari Nagar National Institute of Medical Statistics
New Delhi – 110029 ICMR Head Quarters Campus
Ansari Nagar
Banaras Hindu University, Varanasi
Prof. R.G. Singh, Prof. Dr. Manjari Dwivedi

Department of Nephrology Department of Prasuti Tantra & Stree Roga
Banaras Hindu University Institute of Medical Science (Ayurveda),
Varanasi – 221005 Banaras Hindu University
Varanasi – 221005
Prof. Dr. P.V. Tiwari Prof. I.S. Gambhir
Department of Prasuti Tantra & Stree Roga Department of Medicine
Institute of Medical Science (Ayurveda) Institute of Medical Sciences
Banaras Hindu University Banaras Hindu University
Varanasi – 221005 Varanasi – 221005
Vallabh Bhai Patel Chest Institute, Sir Ganga Ram Hospital, Delhi
University of Delhi, Delhi
Prof. Ashok Shah Dr. S.C. Manchanda

Department of Respiratory Medicine, Department of Cardiology
Vallabh Bhai Patel Chest Institute Sir Ganga Ram Hospital
University of Delhi, Delhi Rajinder Nagar, Delhi – 110060
Ayurvedic & Siddha Experts
Dr. S.K. Mishra Dr. B.V. Sathe

Ex. Advisor (Ay.) 30/2, 4 Erandvan
Department of ISM&H Flat No. C-1, Vihar Society
Ministry of Health & Family Welfare Near Mahendle Garage
Govt. of India Pune - 411004
XII
Dr. S.M. Sathe Dr. G. Veluchamy
Plot No. 9 Ex. Director CCRAS,
Gananjay Society Unit – 1 New Delhi
Azad Nagar, Kothrud
Pune – 411038
Dr. K.D. Sharma

Ex. Deputy Director (Technical)
CCRAS, New Delhi
TECHNICAL SUPPORT
Dr. Seema Jain, Dr. Syed Hissar,

Senior Research Fellow (Ay.), Research Officer (Medicine),
Dr. Senthilvel, Dr. Selvarajan,
Research Officer (Siddha), Research Officer (Siddha),
R.K. Rana, Dr. Babita Yadav,
Statistical Assistant, Senior Research Fellow (Ay.),
Richa Singhal, Dr. Suprabhat Bhardwaj,
Senior Research Fellow (Statistics), Senior Research Fellow (Ay.),
Dr. Nikhil Jirankalgikar

Senior Research Fellow (Ay.),
CCRAS, New Delhi
XIII
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XIV
INDEX
Sl. No. Subject Page

Forward III
Preface V
1. Section – I Respiratory System 1
1. 1.1 Allergic Bronchitis (Kasa) 5
2. 1.2 Bronchial Asthma (Tamaka shwasa) 33
2. Section – II Gastro intestinal System 61
1. 2.1 Irritable Bowel Syndrome (Kaphaja pravahika) 65
2. 2.2 Intestinal Helminthes Krimi roga (Gandupada krimi) 87
3. 2.3 Gall Stone Disease (Pittashmari) 111
4. 2.4 Sero conversion of HBsAg (carriers) (Yakrit vikara) 133
3. Section – III Joint Disorders 149
1. 3.1 Osteoarthritis-Knee Joint (Sandhi-vata) 153
2. 3.2 Rheumatoid Arthritis (Amavata) 185
3. 3.3 Osteoporosis (Asthisausirya) 231
4. Section – IV Ano-rectal Disorder 245
1. 4.1 Fissure-in-Ano (Parikartika) 249
2. 4.2 Piles (Arsha) 273
3. 4.3 Fistula-in-Ano (Bhagandara) 293
5. Section – V Nervous System 313
1. 5.1 Hemiplegia (Pakshaghata) 317
2. 5.2 Migraine (Ardhavabhedaka) 341
3. 5.3 Mental Retardation (Manasa Mandata) 357
4. 5.4 Sciatica (Gridhrasi) 387
5. 5.5 Anxiety Neurosis (Manodvega) 415
XV
6. Section – VI Metabolic Disorders 437
1. 6.1 Obesity (Medoroga) 441
2. 6.2 Diabetes Mellitus (Madhumeha) 459
7. Section – VII Eye Disorders 479
1. 7.1 Cataract (Linganasha) 483
2. 7.2 Dry Eye Syndrome (Shushkakshipaka / Parishuskha 501
Netra)
3. 7.3 Allergic Conjunctivitis (Kaphaja abhishyanda) 519
8. Section – VIII Connective Tissue Disorders 535
1. 8.1 Deep Vein Thrombosis 539
9. Section – IX Geriatric Disorders 557
1. 9.1 Rejuvenation (Rasayana) in healthy elderly persons 561
2. 9.2 Rejuvenation (Kaya kalpa) in healthy elderly persons 593
10. Section – X Reproductive System 615
1. 10.1 Menopausal Syndrome 619
2. 10.2 Dysfunctional Uterine Bleeding 643
3. 10.3 Dysmenorrhoea (Kashtartava) 661
11. Section – XI Cardio Vascular System 701
1. 11.1 Essential Hypertension (Uchcharaktachapa) 705
2. 11.2 Chronic Stable Angina (Hridroga) 727
12. Section – XII Urinary System 745
1. 12.1 Urolithiasis (Mutrashmari) 749
13. Section – XIII Vector Borne Diseases 769
1. 13.1 Kala-Azar 773
2. 13.2 Filariasis (Shleepada) 801
14. Section – XIV Haematological Disorders 827
1. 14.1 Iron Deficiency Anaemia (Pandu) 831
2. 14.2 Sickle Cell Anemia 865
XVI
15. Section – XV Immune System 883
1. 15.1 HIV Infected Persons 887
16. Section – XVI Disorders of Skin 911
1. 16.1 Psoriasis (Kitibha) 915
17. Section – XVII Reproductive and Child Health Care 941
1. 17.1 AYUSH AG TAB during Pregnancy 943
2. 17.2 AYUSH PG TAB in edema during pregnancy 958
3. 17.3 AYUSH B.R. Leham for immunity in infants 973
4. 17.4 AYUSH PK-Avaleha in preventing postpartum 985
complications and puerperial care.
5. 17.5 AYUSH SS-Granules to ensure quality & quantity of 996
breast milk
18. Section – XVIII Clinical Safety of some 1007
Ayurveda and Siddha Drugs
1. 18.1 Clinical safety of herbo-mineral and metallic preparation 1011
(Rasamanikya Rasa)
2. 18.2 Clinical safety of herbo-mineral and metallic preparation 1049
(Vasantakusumakara Rasa).
19. Section – XIX Annexure 1085
1. 19.1 Case Report Form for determination of 1087
Prakriti/Udaliyal/Mizaj
XVII
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XVIII
RESPIRATORY SYSTEM
SECTION - I
1
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2
MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC
FORMULATION IN THE TREATMENT OF KASA
(BRONCHITIS)
Drug: Study Code:
PROTOCOL & CASE REPORT FORMS (CRF)
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA

AND SIDDHA
3
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4
MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF KASA (BRONCHITIS)
I. BACKGROUND
Kasa (Bronchitis)1is prevalent all over the world and certainly most common acute disease
of lungs. It is characterized by inflammation of brochial tubes and is much more common in
childhood and after middle age. Attacks are much more likely to occur in the winter and spring
seasons. The disease commonly commences with symptoms of an acute respiratory infection and
a slight sore throat. In the course of a day or so it affects the trachea and larger bronchi with
feeling of soreness behind the sternum, tightness in the chest, frequent and mainly dry cough and
a rise in temperature. The voice becomes husky. The sputum is initially thick and scanty but later
on becomes more copious, mucopurulent and more easily to cough ups. In the cases of great
severity, there is a severe bronchitis affecting the larger and smaller tubes, a high rising temperature
(104o – 105o F), severe dyspnoea, cyanosis, and prostration. The sputum may be streaked with
blood. Especially at extremes of life death may occur, or recovery will be taking 4-8 weeks.
According to modern medicine, bronchitis may follow exposure to cold. In majority of cases there
is an infection of upper respiratory tract. A number of drugs including antibiotics are available for
the successful treatment of the disease but recurrence of the condition, development of bacterial
resistance against drug is now a days common. Besides of these number of side effects, adverse
effects of antibiotic therapies have been reported time to time. So it is better to seek for a safe
and effective alternative treatment for the cure.
The disease is very well described in Ayurveda and a number of drugs have been
mentioned. Vyaghriharitaki is one of the classical compound drugs which has been in practice since
ancient times for its successful treatment. A protocol is designed here with special reterence
Vyaghriharitaki which may be principally utilized for management with suitable ammendments.
References
1. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Sutra Sthana, Chapter 25, Verses 40
2. Savill’s System of Clinical Medicine- revised and edited by E.C.Warner, 14th edition, page No. 183- 186
3. Davidson’s Principle and Practice of Medicine 18th Edition pages 339
4. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Chikista Sthana, Chapter 18, Verses 10
&133
5. www.emedicinehealth.com
5
II. OBJECTIVES
1. To evaluate the clinical efficacy of Vyaghriharitaki in the cases of Kasa (bronchitis)
2. To validate the clinical efficacy of Ayurvedic drug Vyaghriharitaki on the scientific
parameters in the patients of Kasa (bronchitis)
3. To evaluate the safety of Vyaghriharitaki in the patients of Kasa (bronchitis).
III. CENTRES
CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE & METHODS
Sample size — 120 (60 patients in each group)
Design of the study — Open clinical study.
Drug/Dosage/Duration
Group – A — Vyaghriharitaki without restriction of pathyapathya
(Restrictions related to diets and life style).
Group – B — Vyaghriharitaki with restrictions of pathyapathya
Dose & Duration — 2.5 gm B.D. for 1 (one) month
Total period — 1 year and 6 months to complete the study
V. CRITERIA FOR INCLUSION
1. Patients of either sex with Age between 15 years to 60 years
2. Cases with confirmed diagnosis by signs/symptoms/lab findings of bronchitis.
3. Duration of illness not more than 6 months.
4. Repeated attacks of bronchitis
5. Smokers.
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and more than 60 years
2. Cough associated with other respiratory disorders like Bronchial carcinoma, Bronchial
Asthma, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung
disease, tropical pulmonary eosinophilia, Loffler`s disease, Allergic Bronchopulmonary
Aspergillosis etc.
3. Diabetes Mellitus, Hypertension and other serious cardiovascular disorders.
6
4. Severe renal/Hepatic disease
5. HIV positive cases
6. Pregnant/lactating mother
7. Any other serious systemic disease.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
effect / event which requires urgent treatment or if patient by own wants to withdraw from the
study, such subjects may be withdrawn from the trial and managed by the Principal Investigator
accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Screen of the patient will be recorded as per the proforma (Form I). The full details of
history and physical examination of the patients will be recorded as per the proforma (Forms II).
Clinical assessment will be done before treatment, at 15 days of treatment period and at the end of
the treatment as per proforma - III. The laboratory investigations will be carried out before and after
treatment as recorded as proforma - IIIA. Adverse events will berecorded in the proforma - IV.
IX. STATISTICAL ANALYSIS
Data collected will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the score of clinical signs and symptoms and laboratory findings and safety
evaluation will be made on the basis of serial recording of the adverse events if any and Liver and
Kidney function tests as PROFORMA II B and III.
XI. TRIAL MONITORING AND STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in). The monitoring of progress of the trial will also be undertaken by
CCRAS Hqrs. New Delhi.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial centre for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
7
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board, any life threatening conditions whether
they are perceived to be study related or not. The Board will decide whether the adverse
effects warrant discontinuation of the study protocol or not. Protocols will be written and
approved for the treatment of study related adverse events about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to each subject as an incentive.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at C.C.R.A.S. Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial conduct
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
8
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Therapeutic Efficacy & Safety of Vyaghriharitaki in the
management of Kasa (Bronchitis)
Date:___________ Name of the Subject:_____________________________
Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________
To be translated into regional language.
9
PATIENT INFORMATION SHEET
What is the study about?

Kasa (Bronchitis) is prevalent all over the world and certainly most common acute disease
of lungs. It is characterized by inflammation of bronchial tubes and is much more common in
childhood and after middle age. Attacks are much more likely to occur in the winter and spring
season of the year. The disease commonly commences with symptoms of an acute respiratory
infection and a slight sore throat. In the course of a day or so it affects the trachea and larger
bronchi with feeling of soreness behind the sternum, tightness in the chest, a frequent and mainly
in dry cough and a rise in temperature. The voice becomes husky. The sputum is initially thick and
scanty but later on becomes more copious, mucopurulent and more easily to cough ups.
The available treatment for bronchitis in modern medical science like antibiotics, anti
tussives, expectorants, bronchodilators etc. made tremendous success in providing instant or
symptomatic relief but there are certain side effects of these drugs. In Ayurveda, many drugs seem
to possess better curative effect in the cases of Kasa (bronchitis) that have been in practice since
years successfully.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 1 month to complete. During this
period, you are expected to visit the hospital 3 times for clinical and/or pathological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, X-ray, blood and urine samples will also be taken. If you are found eligible,
you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc. are
noticed during the treatment period, this should be brought to the notice of the Principal
Investigator.
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CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
2. Code No. (of clinical trial)
3. Name of the subject: ………………………………........…………………………………
4. Gender: Male (1) Female (2)
5. Date of Birth: Age (in yrs.) :
6. Address ……………………………………..………………………………………
CRITERIA FOR INCLUSION Yes (1) No (0)
1. Age between 15 to 60 years
2. Both the sexes irrespective of caste/religion.
3. Uncomplicated cases of bronchitis.
4. Repeated attacks of bronchitis.
CRITERIA FOR EXCLUSION Yes (1) No (0)
5. Age below 15 years and above 60 years.
6. Cough associated with other respiratory disorders

like Bronchial carcinoma.
7. Bronchial Asthma, Bronchiectasis, cases of tuberculosis,
8. Interstitial lung disease/occupational Lung disease, tropical
9. Pulmonary eosinophilia, Loffler s disease, Allergic

Bronchopulmonary Aspergillosis etc
11
10. Diabetes Mellitus and Hypertension and other
serious cardiovascular disorders.
A patient is eligible for admission to the trial
If Sl.No.1-4 is ‘Yes’ and Sl.No.5-12 are ‘No’
If admitted, Sr. No. of the Subject: _________________________

No. of packets issued: _________________________
Date: __________________ Signature of the investigator: ___________________
12
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
3. Sr. No. of the subject: ……………………………........…………………………………
4. Name of the Subject: ...........................................................................................................
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
Middle School (4) High School (5) College (6)
Other (specify) (7) I.N.A. (8)
9. Occupation: Desk work(1) Field work (2)
Field work with physical labour (3)
Field work with intellectual (4)
Indicate nature of work: ...........................................................................
10. Income (per capita per month in Rs.): ____________________________

of the participant and Head of the family
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)
11. Cough (Dry/Productive)
13
12. Sputum - Thick and scanty/Mucoid/
Mucopurulent/Streaks with blood
13. Dyspnoea
14. Wheezing
15. Chest Pain
16. Tightness in chest
17. Fever
18. Sore throat
19. Onset of disease Acute (1) Chronic (2)
20. Previous episodes Yes (1) No (0)
21. Treatment given so far: Traditional Medicine (1) Modern Medicine (2)
PERSONAL HISTORY
22. Diet Veg (1) Non-veg (2)
23. Sleep Normal (1) Duration in hours______________________
Abnormal(2) Duration in hours______________________
24. Constipation Yes (1) No (0)
25. Addiction Yes (1) No (0)
a). Smoking
If yes specify: (a) Quantity [packs]:__________________
(b) Total Duration in years: ____________
b). Tobacco Yes (1) No (0)
14
c). Alcohol Yes (1) No (0)
If yes specify: (a) Quantity (ml)_________
(b) Total Duration in years_______________
d). Any other (specify)________________
26. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)
Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja(6)
Sannipataj (7)
27. Manasa Prakriti: Satwika (1) Rajasa (2) Tamasa (3)
PHYSICAL EXAMINATION
28. Built Lean (1) Medium (2) Heavy (3)
29. Gait Normal (1) Abnormal (0)
30. Body weight _________Kg.
31. Height in cms._________
32. Body temperature ____________o F
33. Blood pressure (in sitting posture of right upper limb):
Systolic _______mm/Hg Diastolic _______mm/Hg
34. Pulse rate__________/min. (Radial pulse of right upper limb)
35. Respiration rate _________/min.
Present (1) Absent (0)

36. Pallor
37. Jaundice
38. Koilonychia
39. Cyanosis
40. Lymphadenopathy
15
SYSTEMIC EXAMINATION
41. Digestive system Normal(1) Abnormal(0)
If Abnormal, specify abnormalities_________________________
42. Abdomen Palpable (1) Not palpable (2)
i) Liver
ii) Spleen
Normal (1) Abnormal (2)
43. CNS
If abnormal, specify abnormalities_____________________________
44. CVS with chest
45. Uro-genital system
46. Respiratory system
SAMPRAPTI (PATHOGENESIS)
Vata (1) Pitta (2) Kapha (3)
47. Anubandhya dosha
48. Anubandh dosha
49. Avaraka dosha
50. Ksheen dosha
51. Ksheen dhatu Rasa (1) Rakta (2) Mamsa(3)
Meda(4) Asthi (5) Majja (6)
Shukra(7) Ojas (8)
16
52. Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)
Meda (4) Asthi (5) Majja (6)
Shukra (7) Ojas (8)
53. Stages of disease (Roga Kriya Kala)
Sanchaya(1) Prakopa(2) Prasara (3)
Sthan Sanshray (4) Vyakti (5) Bheda (6)
Srotas Pareeksha
54. Pran vaha srota
Alpa Alpa Swasa (Shortened Breathing) (1)
Atisrama Swasa (Increased respiration rate) (2)
Abhikshana Swasa (Chyne stroke breathing) (3)
Kupit Swasa (Vitiated breathing) (4)
Sashula swasa (Dyspnoea with pain) (5)
55. Udakavaha srota
Jihva sosha (Dryness of tongue) (1)
Oustha sosha (Dryness of lip) (2)
Talu sosha (Dryness of palate) (3)
Kantha sosha (Dryness of throat) (4)
Kloma sosha (Excessive thirst) (5)
Trishna (Thirst) (6)
56. Annavaha srota
Anannabhilasha (Lack of desire for food) (1)
Aruchi (Anorexia) (2)
17
Avipaka (Indigestion) (3)
Chhardi (Vomitting) (4)
57. Rasa Vaha srotas
Mukha vairsya (Bad taste in mouth) (1)
Arasajnata (Tastelessness) (2)
Hrillasa (Water brash) (3)
Gaurava (Feeling of heaviness) (4)
Tandra (Stupor) (5)
Anga marda (Body ache) (6)
Jwara (Fever) (7)
Pandu (Anaemia) (8)
Avsada (Depression) (9)
Klibya (Loss of libibo) (10)
Karshya (Emaciation) (11)
Agnimandya (Diminished appetite) (12)
58. Rakta vaha srotas
Pidika (Boils) (1)
Rakta Pitta (Bleeding from any of the orifice) (2)
Mukha Pak (Stomatitis) (3)
Vidradhi (Abscess) (4)
Charma roga (Skin disease) (5)
Kamala (Jaundice) (6)
18
59. Mamsavaha srotas
Arubud (Tumour) (1)
Aljee (Phlyctenular conjunctivitis) (2)
Gandamalaa (cervical lymphadenitis) (3)
Upji (Epiglotis) (4)
Adhimamsa (Protruberance of flesh/cancer/cyst) (5)
Putimamsa (decayed flesh/gangrene) (6)
60. Medo vaha srotas
Maladhikya (Excess of excreta) (1)
Hastapada daha (Burning sensation in the palm and sole) (2)
Hastapada suptata (Numbness of the palm and sole) (3)
Tandra (Stupor) (4)
Dehachikkanta (Greasiness of the skin) (5)
Alasya (Lethargy) (6)
61. Asthivaha srotas
Adhyasthi (Hypertrophy of bone) (1)
Adhidanta (Redundant tooth) (2)
Dantshoola (Toothache) (3)
Asthi shoola (Bone pain) (4)
Kesha, loma, nakha, samshru vikara (5)

(Any defects of hair, hair follicles, nails and mustaches)
62. Majja_vaha srotas
Parva shoola (Pain in the Interphalangeal joints) (1)
Bhrama (Vertigo/Giddiness) (2)
19
Moorchh (Syncope) (3)
Mithyajnana (Illusion) (4)
63. Shukra_vaha srotas
Klaivya (Sterility / impotence) (1)
Aharshan (Loss of erection) (2)
Garbha pata (Abortion) (3)
Santam Vikriti (Congenital deformity of the children) (4)
64. Manovaha srotas
Manovibramsha (1)
Budhivibramsha (2)
Sanjna Vibhramsha (3)
Smritivibhramsha (4)
Bhaktivibhramsha (5)
Sheelavibhramsha (6)
Chesta Vibhramsha (7)
Acharavibhramsha (8)
65. Artava vaha srotas
Anartava (Amenorrhoea) (1)
Vandhyatva (Sterility) (2)
66. Mutra vaha srotas
Bahumutra (Polyuria) (1)
Atibadhata (Urination with obstruction) (2)
Prakop-mutra (Defective Urination / Difficulty (3)

in micturition)
20
Alpaalpa (Scanty urination) (4)
Aabhikshna (Constant / repeated urination) (5)
Bahulamutrata (Urine with prostatic secretion) (6)
Sashool amutrata (Painful micturition) (7)
67. Pureeshavaha srotas
Alpaalpa Pureesha (Scanty defecation) (1)
Sashoola Pureesha (Painful defecation) (2)
Atidrava Pureesha (Diarrhoea) (3)
Atigrathita yukta Pureesha (Scybala) (4)
68. Sweda vaha srotas
Aswedan (Loss of perspiration) (1)
Atiswedana (Profuse sweating) (2)
Parushya (Roughness of the skin) (3)
Lomaharsha (Thrill) (4)
Aangaparidaha (Burning sensation in the body) (5)
Date: _______________ Signature of the investigator: ______________________
21
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0, 15, 30 days)
1. Centre: ………………..……….
SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.
1. AIRE (ACQ)* ASTHMA CONTROL QUESTIONN
a. On average, during the past week, how often were you woken by your asthma during the
night?
i. Never (0)
ii. Hardly ever (1)
iii. A few times (2)
iv. Several times (3)
v. Many times (4)
vi. A great many times(5)
vii. Unable to sleep because of asthma’

b. On average, during the past week, how bad were your asthma symptoms when you wok up
in the morning?
i. No symptoms (0)
22
ii. Very mild symptoms (1)
iii. Mild symptoms (2)
iv. Moderate symptoms (3)
v. Quite severe symptoms (4)
vi. Severe symptoms (5)
vii. Very severe symptoms (6)
c. In general, during the past week, how limited were you in your activities because of your
asthma?
i. Not limited at all (0)
ii. Very slightly limited (1)
iii. Slightly limited (2)
iv. Moderately limited (3)
v. Very limited (4)
vi. Extremely limited (5)
vii. Total limited (6)
d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?
i. None (0)
ii. A very little (1)
iii. A moderate amount (2)
iv. Quite a lot (3)
v. A great deal (4)
vi. A very great deal (5)
e. In general, during t he past week, how much of t he time did your wheeze?
i. Not at all (0)
23
ii. Hardly any of the time (1)
iii. A moderate amount of the time (2)
iv. A lot of the time (3)
v. Most of the time (4)
vi. All the time. (5)
f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
i. None (0)
ii. 1-2 puffs most days (1)
iii. 3-4 puffs most days (2)
iv. 5-8 puffs most days (3)
v. 9-12 puffs most days (4)
vi. 13-16 puffs most days (5)
vii. More than 16 puffs most days.(6)
To be completed by a member of the clinic staff.

8. FEV1 prebronchodilator……………….. 0 > 95% predicted
1 95-90%
FEV1 % predicted…………………….. 2 89-80%
3 79-70%
FEV1 % predicted………………….… 4 69-60%
5 59-50%
6 <50% predicted
PHYSIOLOGICAL ASSESSMENT (To be monitored fortnightly.)
9. Blood pressure Systolic (mm Hg.)/Diastolic (mmHg.):
10. Pulse rate (per minute)
11. Temperature
24
12. Respiratory rate (per minute)
13. FEVI (Spirometery) —————————————————— (% 0f predicted value)
14. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE
Good control (1) Poor control (2)
15. VAS (Visual Analogous Scale)
Red Zone (1) Yellow Zone (2) Green Zone (3)
Serious trouble with Mild Trouble with No Trouble with

Asthma Asthma Asthma
16. Overall impression of well-being by the Subject:
Improved (1) No change (2) Deteriorated (3)
17. Status of the patient:
Continuing (1)
Drop out (2)
Reason a) self withdrawn by the patient (1)
b) Physician wants to withdrawn the patient (2)
Date: ______________ Signature of Investigator __________________
25
CASE REPORT FORM IIIA - ADVERSE EVENTS RECORD FORM
(0, 15, 30 days)
1. Centre: ………………..……….
ADVERSE EVENTS
Do the patients have any symptoms with medication in trial groups? Yes (1) No (0)
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
Date started
Date
26
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
*Mild-No interference with usual activity. *Moderate-Significant interference with usual
activities. *Severe-Prevents usual activities.
Serious*
Yes-1
No-2
Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient
hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.
Relationship to study
medication
Unrelated-1
Possible-2
Probable-3
27
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs
could have been produced by the patients clinical stage, intermittent illness, trauma, accidents
etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patients clinical state.
28
FORM IV– LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at
‘0’ week and Kidney, Liver function tests 0th, 15th and 30th day only)
1. Centre: ………………..……….
Urine Examination
7. Routine____________
8. Microscopic___________
Blood Examination
9. DC: P (%) ________ L (%) ________ E (%) ________ M (%) ________B (%) _______
10. Hb (g/dl) _________.
11. ESR (1st hour.)(mm) __________
12. Blood Sugar:
Fasting (mg./dl) _______________
PP. (mg. /dl) _______________
13. Uric acid (mg./dl) _____________
29
Kidney function tests (Sl.No.14 & 15)
14. B. Urea (mg. /dl) _______________
15. S. Creatinine (mg. /dl) ______________
Liver function tests (Sl.No.16 to 22)
16. Total proteins (g. /dl) _______________
17. Albumin (g. /dl) _______________
18. Globulin (g. /dl) _______________
19. A/G Ratio _______________
20. S. Bilirubin (mg. /dL)
Total
Direct
Indirect
21. SGPT. (IU/L)
22. SGOT (IU/L)
23. Alk. Phosphates (KA units) _______________
24. X-ray chest PA View (‘0’ WEEK only)
25. ECG (0, 4 week & if symptoms suggest sos)
26. Any other Remarks _________________________________________________
Date: ________________ Signature of the Investigator: _______________________
30
ASSESSMENT OF SAFETY AND THERAPEUTIC
EFFICACY OF SHIRISHADI KWATHA IN THE
MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)
Drug: Study Code:

AND SIDDHA
31
Blank
32
ASSESSMENT OF SAFETY AND THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)
I. BACKGROUND
Tamaka Shwasa1 (Bronchial asthma) is prevalent all over the world. It is characterized
by chronic airway inflammation and increased airway responsiveness resulting in symptoms of
wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow
limitations usually reverses spontaneously or with treatment. The available treatment in modern
medical science like bronchodilators, steroids even in the form of inhalers and leukatriens modifiers
have made tremendous success in providing instant or symptomatic relief in Bronchial asthma. But
there is recurrent acute exacerbation and remissions and treatment has many side effects like
nausea, vomiting, tremor, huskiness of voice, disturbance of hypothalamus – pituitary –adrenal axis.
In Ayurveda, Shireeshadi kwatha (3) which has been in practice as well as has shown
anti-asthmatic effect in the clinical studies conducted in BHU, Varanasi & in clinical units of Central
Council for Research in Ayurveda and Siddha, Department of ISM & H, Ministry of Health &
Family Welfare, New Delhi.
The toxicity studies done at the Industrial Toxicology Research Center(CSIR), Lucknow,
December, 2002 report showed no acute and sub-acute toxicity of Shirisadi kwath at the dose of
2500 mg. per Kg. Single dose (acute oral) and 200 ml. per kg. per day (subacute oral 1ml=0.5
mg.) in mice.
References
1. Davidson’s Principle and Practice of Medicine 19th Edition pages 513-521
2. Charaka Samhita, Chikitsa Sthana, Hikka swasha, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath,
Choukhamba Orientalia, Varanasi
3. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 51, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
4. Harrison’s Principle of Internal medicine: 15th Edition pages 1456-1460
5. Annual Reports, P.R.U., Haffkine Institute, Bombay
6. Annual Report, P.R.U., L.H.M.C., New Delhi.
33
II. OBJECTIVE
Primary Objective:
To evaluate the comparative efficacy of Shireeshadi kwatha & sustained-release
theophylline in the mild persistent asthma.
Secondary Objective:
To evaluate the safety of Shireeshadi kwatha in the patients of mild persistent asthma.
III. CENTRE: CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE AND METHODS
Sample Size: 250 (125 patients in each group)
Treatment:
A. Pre-treatment period:
There will be wash out period of two week (any oral bronchodilators should be
withdrawn gradually in both groups and patients in both groups will be allowed to take beta-2
agonist inhalation s.os.).
B. Treatment period:
1. Trial drugs:
i) Shirishadi Kwatha(Decoction)
Shirishadi kwatha (50 gm.) contains Albizzia Lebbeck (Shirish) , Solanum Surattence
(Kantkari), Adhatoda Vasica leaves (Vasa), Hedychium Spicatum (Shati) and equal in quantity.
Method of preparation of decoction: 50 gm. powder should be mixed in 400 ml of
water and reduced to 100 ml. by boiling on low flame and constant stirring. It should then be
filtered.
Dose & Duration: 100 ml in three divided doses daily for ninety days
2. Control Drug: theophylline sustained release tablet.
Dose: 400mg orally after dinner once daily.
Salbutamol inhaler 100 mcg.2 puffs sos is allowed if patient may feel acute
Breathlessness in both groups in pretreatment & treatment period. If patients ave
constipation, patient can take Vyaghri Haritaki 3-6 gm. with lukewarm water.
Design of the study – randomized controlled clinical study.
34
Duration of the study – 3 months drug therapy.
Period of Study: 3 months drug treatment period. Total duration will be 1 years to
complete the trial. Recruitment of the patients up to seven months, treatment period for three
months in both groups and data will be analyzed in next two months.
1. Age between 18 years to 40 years.
2. Both the sexes with equal distribution with or without rhinitis.
3. Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6
months.
4. Asthmatics who meet reversibility criteria (15% improvement in FEV I after beta-2
agonist inhalation).
5. Symptoms/exacerbation (Wheeze, cough and breathlessness) greater than weekly and less
than daily in frequency.
6. Night symptoms > twice per month but less than once a week.
7. FEV1 > 80% of the predicted value.
8. Never smokers.
1. Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
2. FEV<80%.
4. Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis,
Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis,
interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia, Loffler
s disease & Allergic Bronchopulmonary Aspergillosis etc
5. Diabetes Mellitus and Hypertension.
9. Patient who need Salbutamol inhaler daily.
35
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
The full details of history and physical examination of the patients will be recorded as per the
proforma (Forms I & IA). Clinical and physiological assessment will be done before treatment
and fortnightly during treatment period and at the end of the treatment. The laboratory
investigations will be carried out as per recorded in the proforma.
Data collected on scores of ACQ (ANNEX-1) & VAS (ANNEX-2) based on which
progress of treatment will be analyzed using appropriate statistical tools.
improvement in the score of ASTHMA CONTROL QUESTIONNAIRE (Anexxure-1) and VAS
(ANNEX-2) and safety evaluation will be made on the basis of serial recording of the adverse
events and Liver and Kidney function tests as per recorded in the proforma II B and III.
XI. TRIAL MONITORING AND DATA ANALYSES
The monitoring of progress of the trial and data analysis will be undertaken by CCRAS,
Hqrs., New Delhi.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating Center’s should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial. The study will be
conducted in accordance with Good Clinical Practice. This incorporates principles laid down in
the Declaration of Helsinki.
A consolidated amount of Rs…../- per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th, 75th and 90th days (7 times).
36
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
37
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial on “Assessment of Safety & Therapeutic Efficacy of Shireeshadi kwatha in the
management of Mild Persistent Asthma (Tamaka Swasa).
Relationship ___________________________________
38
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
(TAMAKA SWASA)

The available treatment for bronchial asthma in modern medical science like broncho-
dilators, steroids even in the form of inhalers have made tremendous success in providing instant
or symptomatic relief but there is recurrent acute exacerbation and remission. In Ayurveda, many
drugs seem to possess a anti asthmatic effect of which Shirishadi Kwatha that have been in
practice as well as have shown anti-asthmatic effect have been taken up for the study.
instructions scrupulously. The study will take approximately 3 months to complete. During this
period, you are expected to visit the hospital 6 times for clinical and physiological assessment.
physical examination, ECG and an X-ray, Blood and urine samples will also be taken. This is to
make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 3 months.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.
39
(TAMAKA SWASA)
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
1. Centre: ………………..……….
3. Name of the person: ………………………………........…………………………………
6. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________
7. Age between 18 years to 40 years
8. Both the sexes with equal distribution with or without rhinitis.
9. Mild persistent cases of Asthma (as per WHO

GINA Guideline) of duration more than 6 months.
10. Asthmatics who meet reversibility criteria

(15% improvement in FEV I after Beta-2 agonist inhalation.)
11. Symptoms/exacerbation (Wheeze, cough and breathlessness)

greater than weekly and less than daily in frequency.
12. Night symptoms > twice per month.
13. FEV1 > 80% of the predicted value.
40
14. Ever smoker.
15. Mild intermittent, Moderated persistent, severe

persistent to severe Asthma.
16. FEV<80%
18. Dyspnoea due to other disease like Left ventricular

failure, COPD (Chronic Bronchitis, Emphysema),
Upper respiratory tract obstruction, Bronchiectasis,
cases of tuberculosis, interstitial lung disease/occupational
Lung disease, tropical pulmonary eosinophilia etc.
19. Uncontrolled Diabetes Mellitus and Hypertension.
20. Any other systemic disorder
23. Asthmatics that need daily Salbutamol inhaler.
A patient is eligible for admission to the trail
Date: ____________ Signature of the Investigator______________
41
(TAMAKA SWASA)
1. Centre: ………………..……….
8. Occupation: Desk work(1) Field work (2) Student (3)
Housewife (4) Others (5)
9. Income per capita per month (in Rs.)
Less than Rs.5000/- (1) More than Rs.-5000/- (2)
Chief complaint with duration (if any) in months
Present (1) Absent (0) If present,

then duration
10. Breathlessness
42
11. Paroxysm of breathlessness
12. Wheezing
13. Cough
14. Expectoration of sputum
15. Nasal symptoms
16. Tightness in chest
17. Night symptoms
Yes (1) No (0) No. of attack

Per month
a). Breathlessness,
b). Wheezing
c). Awakening in the night)
Present (1) Absent (0) If present,

then duration
18. Skin allergy
History of Present illness:
19. History of Nasal symptoms
Yes (1) No (0)
1. Sneezing
2. Running nose
3. Blocked nose
4. Post nasal drip
5. History of throat clearing
If yes then specify: ...............................................................................................
43
Treatment History
Yes (1) No (0)
20. Traditional/Homeopathic Medicine
21. Modern Medicine
History of Past illness:
Yes (1) No (0)
22. History of skin allergy
23. Repeated colds
If yes indicate frequency of attack in months……………………………..
24. Family History of Asthma Present (1) Absent (0)
If present then specify:
Parents (1) Sibling (2) Both (3)
Personal History:
25. Diet: Veg (1) Non-Veg (2)
26. Any food/drink aggravated the symptoms Yes (1) No (0)
If yes, specify: ……………………………………………
27. Sleep Satisfactory (1) Unsatisfactory (2)
28. Constipation No (0) Yes (1)
History of Environmental
Yes (1) No (0)
29. Tobacco smoking exposure
If yes specify whether it aggravated the symptoms or not: …………………………
44
30. Tobacco chewing
If yes specify: (a) Quantity _____________
(b) Total duration in years: _____________
31. Betel chewing
32. History of alcohol intake:
Occasional (1) : 1
Regular (2) : 2
Never (3) : 3
33. Prakriti:
Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja (6)
Sama (7)
Physical Examination
34. Height (cm): ____________
35. Weight (kg) ____________
36. B.M.I
{ Weight (kg.)
Height (meters) 2 } ____________
37. Pulse (per min) ____________
38. Blood Pressure (mm Hg) ____________
39. Body temperature (o F) ____________
40. Respiration rate (per min) ____________
41. Cyanosis ____________
42. Clubbing nails ____________
45
43. Edema ____________
Absent (0) Present (1)
44. Pallor
45. Lymphadenopathy
If present, specify General(1) Local (2)
(Area)__________
Systemic Examination
46. Respiratory System Normal(1) Abnormal (2)
Shape of chest:
Auscultation
Ronchi: Present (1) Absent (2)
47. CVS Normal (1) Abnormal (2)
If abnormal, details____________________________________________
48. Appetite Normal (1) Abnormal (2)
If abnormal, details ______________________________________________
Date: …………….. Signature of Investigator: ……………………………….....
46
(TAMAKA SWASA)
FORM III -CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………..……….
_______________________________________________________________________
_______________________________________________________________________
SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.
ASTHMA CONTROL QUESTIONNAIRE (ACQ)*
a. On average, during the past week, how often were you woken by your asthma during the
night?
i. Never (0)
ii. Hardly ever (1)
iii. A few times (2)
iv. Several times (3)
v. Many times (4)
vi. A great many times (5)
47
vii. Unable to sleep because of asthma’ (6)
* To be translated in Regional language
b. On average, during the past week, how bad were your asthma symptoms when you wok up
in the morning?
i. No symptoms (0)
ii. Very mild symptoms (1)
iii. Mild symptoms (2)
iv. Moderate symptoms (3)
v. Quite severe symptoms (4)
vi. Severe symptoms (5)
vii. Very severe symptoms (6)
c. In general, during the past week, how limited were you in your activities because of your
asthma?
i. Not limited at all (0)
ii. Very slightly limited (1)
iii. Slightly limited (2)
iv. Moderately limited (3)
v. Very limited (4)
vi. Extremely limited (5)
vii. Total limited (6)
d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?
i. None (0)
ii. A very little (1)
iii. A moderate amount (2)
48
iv. Quite a lot (3)
v. A great deal (4)
vi. A very great deal (5)
e. In general, during the past week, how much of the time did your wheeze?
i. Not at all (0)
ii. Hardly any of the time (1)
iii. A moderate amount of the time (2)
iv. A lot of the time (3)
v. Most of the time (4)
vi. All the time. (5)
f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
i. None (0)
ii. 1-2 puffs most days (1)
iii. 3-4 puffs most days (2)
iv. 5-8 puffs most days (3)
v. 9-12 puffs most days (4)
vi. 13-16 puffs most days (5)
vii. More than 16 puffs most days. (6)
* To be completed by a member of the clinic staff.
8. FEV1 prebronchodilator…………………..…… 0 > 95% predicted
1 95-90%
FEV1 % predicted….…………….……........ 2 89-80%
3 79-70%
49
FEV1 % predicted………………………...... 4 69-60%
5 59-50%
6 <50% predicted
PHYSIOLOGICAL ASSESSMENT (To be monitored fortnightly.)
9. a. Blood pressure
i. Systolic (mmHg.)
ii. Diastolic (mmHg.)
b. Pulse rate (per minute)
c. Temperature
d. Respiratory rate (per minute)
e. FEVI (Spirometery): ___________________________
(% 0f predicted value)
10. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE
Good control (1) Poor control (2)
11. VAS (Visual Analogous Scale)

50
13.. Status of the patient:
Continuing (1)
Drop out (2)
Reason a) self withdrawn by the patient (1)
b) Physician wants to withdrawn the patient (2)
51
(TAMAKA SWASA)
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………..……….
_______________________________________________________________________
_______________________________________________________________________
ADVERSE EVENTS
8. Does the patient have any symptoms with medication in trial group? Yes(1) No(0)
1 2 3 4
Adverse
Experience
52
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3

Serious*
Yes-1
No-2

53
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
known characteristics of the patient's clinical state.
54
(TAMAKA SWASA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at ‘O’
week and Kidney, Liver function tests O, 6th and 12th week only.)
1. Centre: ………………..……….
6. Date of Assessment ___________________
7. Urine Examination
Routine____________ Microscopic___________
8. C (Cells/Cmm.)_____________________
9. DLC: P(%)______ L(%)______ E (%)______ M (%)______ B (%)______
10. Absolute Eosinophil count ————————————
11. Hb (g/dl): __________
12. ESR (1st hour.)(mm) __________
13. Blood Sugar:
Fasting (mg./dl) __________
PP. (mg./dl) __________
14. Uric acid (mg./dl)_____________
55
Kidney function tests (Sl.No.14 & 15)
15. B. Urea (mg./dl) _______________
16. S. Creatinine (mg./dl) _______________
Liver function tests (Sl.No.16 to 22)
17. Total proteins (g./dl) _______________
18. Albumin (g./dl) _______________
19. Globulin (g./dl) _______________
20. A/G Ratio _______________
21. S. Bilirubin(mg./dL)
Total: ___________
Direct: ___________
Indirect: ___________
22. SGPT. (IU/L)
23. SGOT (IU/L)
24. Alk. Phosphates(KA units) _______________
25. X-ray chest & PNS(‘0’ WEEK only)
26. ECG(0, 12 WEEK & if symptoms suggest SOS)
27. Any other Remarks: ______________________________________________
Date: ……………. Signature of the Investigator: ………………………........
Place: ……………
56
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-1: ASTHMA CONTROL QUESTIONNAIRE 1
SYMPTOMS: The following clinical symptoms (Serial no 1-5) alongwith question on beta –2
agonist use and another on FEV1% predicted are noted as per ACQ.
Please answer Question 1-6

1. On average, during the past week, how often were you woken by your asthma during the
night?
0. Never (0)
1. Hardly ever (1)
2. A few times (2)
3. Several times (3)
4. Many times (4)
5. A great many times (5)
6. Unable to sleep because of asthma’ (6)
2. On average, during the past week, how bad were your asthma symptoms when you woke
up in the morning?
0 No symptoms (0)
1 Very mild symptoms (1)
2 Mild symptoms (2)
3 Moderate symptoms (3)
4 Quite severe symptoms (4)
5 Severe symptoms (5)
6 Very severe symptoms (6)
3. In general, during the past week, how limited were you in your activities because of your
asthma?
0 Not limited at all (0)
57
1 Very slightly limited (1)
2 Slightly limited (2)
3 Moderately limited (3)
4 Very limited (4)
5 Extremely limited (5)
6 Total limited (6)
4. In general, during the past week, how much shortness of breath did experience because of
your asthma?
0. None (0)
1. A very little (1)
2. A moderate amount (2)
3. Quite a lot (3)
4. A great deal (4)
5. A very great deal (5)
5. In general, during the past week, how much of the time did your wheeze?
0. Not at all (0)
1. Hardly any of the time (1)
2. A moderate amount of the time (2)
3. A lot of the time (3)
4. Most of the time (4)
5. All the time. (5)
6. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
0. None (0)
1. 1-2 puffs most days (1)
58
6. More than 16 puffs most days.
To be completed by a member of the clinic staff.
7. FEV1 prebronchodilator……………...... 0 > 95% predicted
1 95-90%
FEV1 % predicted…….……….....… 2 89-80%
3 79-70%
FEV1 % predicted………………...... 4 69-60%
5 59-50%
6 < 50% predicted
Patients are asked to recall their symptoms & short-acting beta-2 agonist use during the previous
week. All seven questions as mentioned in ACQ are scored on a seven point scale (0=good
control,6=poor control) ,and the overall score is the mean of seven responses.
1: Elizabeth F.Juniper, Paul M et al. Am J Respir Crit Care Med Vol 162 pp1330-34, 2000
59
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-II
Name of Centre: ___________________________________________________________
Name: ___________________________________ Age: _________ Gender: __________
Date:-________ C.R No. _________
VISUAL ANALOGUE SCALE (VAS)1

Scale: 100 mm long 2
Green zone 80 mm-100 mm “No trouble with asthma” 2
Yellow zone 79 mm-50 mm “Mild trouble with asthma” 2
Red zone Below 50 mm “Serious trouble with asthma”2
References
1. J. Asthma 2003; 40:27-39
2. National Heart, Lung, and Blood Institute, Publication No.97-4051, Expert Panel Report II, 1997.
60
GASTRO INTESTINAL SYSTEM
SECTION - II
61
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62
CLINICAL VALIDATION OF BILWAMAJJA CHURNA
IN KAPHAJA PRAVAHIKA (IBS)
Drug: Study Code:

AND SIDDHA
63
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64
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
I. BACKGROUND
Kaphaja Pravahika1 (vis-à-vis Irritable bowel syndrome) is a disease of the
Purishavaha srotas, caused due to excessive intake of unctuous and heavy foods and is
characterised by the association of excessive mucous in the stool along with abdominal pain,
discomfort and bloating.
According to allopathic system of medicine Irritable bowel syndrome (IBS) is a blanket
term for a variety of diseases causing discomfort in the gastro-intestinal tract. It is a functional
bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of
bowel habits in the absence of any organic cause. In some cases, the symptoms are relieved by
bowel movements. Certain psychological conditions are also more common in those with IBS.
Treatments for IBS includes attempt to relieve symptoms, including dietary adjustments, medication
and psychological interventions. Patient education and a good doctor-patient relationship are also
important.
Owing to the complications and adverse effects of current modern medication to manage
such condition, need is felt for search of safe /effective Ayurvedic oral dosage forms with scientific
parameters. Keeping the gravity of the situation and the public health needs in view, the council has
initiated scientific studies on Bilwamajja Churna, a promising herbal drug that is being successfully
prescribed by Ayurvedic physicians without any side effects since centuries in Kaphaja Pravahika
(IBS).
II. OBJECTIVE
To assess the effect of Bilwamajja Churna in reducing the signs and symptoms of Kaphaja
Pravahika (IBS)
References
1. Charaka Samhita, Chikitsa Sthana, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath, Choukhamba
Orientalia, Varanasi
2. Ambika Dutta Sashtri (1989), Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 40,
VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
3. Harrison’s Principle of Internal medicine: 17th Edition, Vol – 1, Page: 970
65
III. CENTERS
CCRAS identified Centers
No. of Groups : One
Sample size : 30 Subjects per center
Trial Drug /Dosage /Duration : Bilwamajja churna 3 gms twice daily after
food for 30 days with warm water for 30
days and follow-up for another 15 days
without medicine.
Design of the study : Open trial
Total period of the study : One year
Follow up study: : For a period of 15 days at the interval of
7 days after completion of the therapy.
1. Age between 15 and 60 years
2. History of frequent passing of little quantity of stool along with mucous and tenesmus.
3. The frequency of passing of stool should be 3 times or more in 24 hours.
4. Stool examination should be positive either with E.H. cyst or E.coli or both.
1. Age below 15 years and above 60 years.
2. Stool test negative for E.H. cyst and/or E.coli.
3. Mixed infection with other parasites like round worms, hook worms etc.
4. Complicated with tuberculosis, malignancy or hepatic abscess.
5. Associated with other grave systemic diseases like cardiac disorders, jaundice, diabetes
mellitus etc.
During the course of the trial, if any serious condition or any serious adverse events which
requires urgent treatment or if subjects themselves want to withdraw from the study, such subjects
may be withdrawn from the trial.
66
The full details of screening and history along with physical examination of the subjects will
be recorded as per case report form I & II respectively. Clinical and physiological assessment in
form III and laboratory investigations in form IV will be done at 0, 15th & 30th days.
Consolidated data on periodical observation will be recorded in case report form-V.
IX. ASSESSMENT CRITERIA :
Sl. Frequency of passing of stool Grade Score

No. motions per 24 hours
1 Up to Two Zero 0
2 3-5 I 2
3 6-8 II 4
4 9 & above III 6
Sl. Tenesmus / Abdominal pain Grade Score

1 Mild (Tolerable by the patient) Zero 0
2 Moderate (Twisting pain in abdomen
but not rolling type) I 2
3 Severe (Un tolerable and rolling type) II 4
Sl. Bloating Grade Score

1 Present Zero 0
2 Absent I 2
Sl. Stool examination for parasite Grade Score

(E.H / E.Coli)
1 Present Zero 0
2 Absent I 2
67
X. STATISTICAL ANALYSIS:
mail (ccras_stat@nic.in).
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Institutional Ethical Committee (IEC): The proposal will be placed before
Institutional Ethical Committee (IEC) of trial center for getting clearance certificate before the
project is initiated. Patient’s information sheet and informed consent form will be submitted along
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in case of
any adverse events occur. The data will be reviewed for every 20 participants included into the
study and administered the trial drugs. The research team will report immediately to the PI and
Data Monitoring Board, any life threatening conditions whether they are perceived to be study
related or not. The Board decides whether the adverse effects warrant discontinuation of the study
protocol. Protocols will be written and approved for the treatment of study related adverse events
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
A consolidated amount of Rs……./- per visit will be paid to subject selected in the study.
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
1. Stool:
Routine & Microscopic
E.H. Cyst & E. Coli
68
Mucous
Occult blood
Ingested Vegetable particles
2. Urine:
Routine & Microscopic
3. Blood:
TLC
DC
Hb%
ESR
FBS
Mx Test
69
PRAVAHIKA (IBS)
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician about the purpose of
the clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
in the “Clinical validation of bilwamajja churna in kaphaja pravahika (IBS)”
Relationship ___________________________________
70
PRAVAHIKA (IBS)

Kaphaja Pravahika (which is consider as Irritable bowel syndrome as per allopathic
system of medicine) is a disease of the Purishavaha srotas, caused due to excessive intake of
onctuous and heavy foods and is characterised by the association of excessive mucous in the stool
along with abdominal pain, discomfort and bloating.
According to allopathic system of medicine Irritable bowel syndrome (IBS) is a blanket
term for a variety of diseases causing discomfort in the gastro-intestinal tract. It is a functional
bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of
bowel habits in the absence of any organic cause. In some cases, the symptoms are relieved by
bowel movements. Certain psychological conditions are also more common in those with IBS.
Owing to the complications and adverse effects of current modern medication to manage
such condition, need is felt for search of safe /effective Ayurvedic oral dosage forms with scientific
parameters. Keeping the gravity of the situation and the public health needs in view, the council has
initiated scientific studies on Bilwamajja Churna, a promising herbal drug, which is being
successfully prescribed by Ayurvedic physicians without any side effects since centuries in Kaphaja
Pravahika (IBS).
instructions scrupulously. The study will take approximately one month (30 days). During
treatment period, you are expected to visit the hospital three times i.e. on 0,7th, 15th and 30th day
for clinical and physiological assessment.
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for 30 days.
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc. are
noticed during the treatment period, this should be brought to the notice of the Principal
Investigator.
71
PRAVAHIKA (IBS)
BEFORE TREATMENT
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
2. History of frequent passing of little quantity of stool
3. along with mucous and tenesmus.
4. The frequency of passing of stool should be 3 times
5. or more for 24 hours
6. Stool should be positive either with E.H. cyst or
7. E. Coli or both
8. Age below 15 years and above 60 years
9. Stool test negative for E.H. cyst and/or E.coli
72
10. Mixed infection with other parasites like round worms,
hook worms etc
11. Complicated with tuberculosis, malignancy or hepatic abscess.
12. Associated with other grave systemic diseases like cardiac

disorders, jaundice, diabetes mellitus etc
Date: __________________ Signature of the investigator: ___________________
73
1. Centre: ………………..……….
3. Sr. No. of the subject: …………………………...............…………………………………
7. Address ……………………………………..……………..........…………………………
10. Annual Income of the family Rs.
Less than Rs.60, 000/- (1) More than Rs.60, 000/- (2)
Total number of members sharing the income:
11. History of previous treatment
12. History of present illness:
74
(in days)
13. Frequent passing of stool
14. Tenesmus
15. Passing of stool with mucous
16. Abdominal pain
17. Bloating
18. Alteration of bowel habits
19. Previous episodes
20. Onset of disease Acute (1) Chronic (2)
21. Treatment given so far:
Traditional Medicine (1) Modern Medicine(2)
PERSONAL HISTORY
23. Digestion (Agni) Proper (1) Improper (2)
24. Sleep Normal (1) Disturbed (2)
If yes, specify ……………………………………………………………………..
26. Bowel habit Regular (1) Irregular (2)
If irregular, specify …………………………………………………………………….
Sannipataj (7)
75
28. Manasa Prakriti: Sattva (1) Rajas (2) Tamas (3)
Sattva-Rajas(4) Rajas-Tamas(5) Sattva-Tamas (6)
Sama (7)
31. Body weight _________Kg. Height in cms. ____________
32. Body temperature ____________oF
33. Blood pressure (in sitting posture of right upper limb):
Systolic _______mm/Hg Diastolic _______mm/Hg
36. Pallor
37. Jaundice
38. Koilonychia
39. Lymphadenopathy
40. Digestive system
41. CNS
If abnormal, specify abnormalities_________________________
76
42. CVS with chest
i) Liver
ii) Spleen
Normal Abnormal
47. Anubandh dosha
48. Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)
Shukra (7) Ojas (8)
49. Srotas: Rasavaha (1) Raktavaha(2) Mamsavaha (3)
Medovaha(4) Annavaha(5) Purishavaha (6)
Mutravaha(7)
Date: _______________ Signature of the investigator: ________________________
77
PRAVAHIKA (IBS)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 7th, 15th, 30th day)
Separate form should be used on each visit
1. Centre: ………………..……….
3. Sr. No. of the subject: ……………………………........………………………….………
4. Name ...................................................................... Age ..................... Sex .......................
5. Date of Assessment ..............................................................................................................
Chief complaints with duration (in days) Yes (1) No (0) if yes, Duration
(in days)
6. Frequent passing of stool
7. Tenesmus
8. Passing of stool with mucous
9. Abdominal pain
10. Bloating
11. Alteration of bowel habits
12. Other symptoms ( if any)
Any other, specify______________________________________
Date: ______________ Signature of investigator___________________
78
PRAVAHIKA (IBS)
(On Day 0, 7th, 15th, 30th day)
CASE REPORT FORM IV-PERIODICAL OBSERVATION AND LABORATORY
ASSESSMENT
1. Centre: ………………..……….
7. Date of Assessment
8. Stool examination
Routine Microscopic
Ova/Cyst
Mucous,
Vegitative cells
Routine Microscopic
Blood
10. TC (Cells/Cu. mm.): _______________
11. DC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
79
12. ESR (mm / 1st hour.) __________
13. Hb (g/dl) ____________________
Liver function tests
14. S. Bilirubin
• Total (mg/dl)
• Direct (mg/dl)
15. SGPT (IU/L)
16. SGOT (IU/L)
17. S. Alkaline phosphatase (U/L)
18. S. Proteins (Total) (g/dl)
• Albumin (g/dl)
• Globulin (g/dl)
Renal function tests
19. Blood urea (mg/dl)
20. S.Creatinine (mg/dl)
Specific Investigations:
21. Stool culture
22. Mx Test
23. FBS
Date: _____________ Signature of investigator _______________________
80
PRAVAHIKA (IBS)
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
1. Centre: ………………..……….
Sl Subjective/ objective 0 day/BT 7th dayDt. 15th dayDt. 30th day/AT

Parameters Dt. Dt. Dt. Dt.
1. Frequent passing of
stool
2. Tenesmus
3. Passing of stool with
mucous
4. Abdominal pain
5. Bloating
6. Alteration of bowel
habits
7. Adverse reactions
Burning sensation in Not
abdomen applicable
Nausea Not applicable
81
Diarrhoea Not applicable
Skin rashes Not applicable
8. TC (Cells/Cu. mm.) Not applicable
9. DCLLLL P _____% P _____% P _____%
L _____% Not L _____% L _____%
E _____% applicable E _____% E _____%
10. ESR (mm / 1st hour.) Not
applicable
Sl Subjective/ 0 day/ 7th day 15th day 30th day/

objective BT Dt. Dt. Dt. AT Dt.
Parameters
11. Hb (g/dl)
12. Liver function
tests
13. S. Bilirubin
a. Total
(mg/dl) Not Not
b. Direct applicable applicable
(mg/dl)
14. SGPT (IU/L)
15. SGOT (IU/L)
16. S. Alkaline
phosphatase
(U/L)
17. S. Proteins
(Total) (g/dl)
18. Albumin (g/dl)
19. Globulin (g/dl)
20. Renal function
tests
21. Blood urea Not Not
(mg/dl) applicable applicable
82
22. S. Creatinine
(mg/dl)
23. Urine
Examination
Routine Not
applicable
Microscopic Not
applicable
24. Stool
Examination
Occult Blood Not Not
applicable applicable
Ova/Cyst Not Not
Mucous Not Not
Vegetative Not Not
cells applicable applicable
8. Overall clinical assessment
9. Overall impression of well being by the Subject:
10. Status of the subject:
Completed (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
Date: ______________ Signature of investigator ______________
83
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84
MULTICENTRIC OPEN CLINICAL TRIAL OF
PALASABEEJA CHURNA IN KRIMI ROGA
(GANDUPADA KRIMI)
Drug: Study Code:

AND SIDDHA
85
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86
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
I. BACKGROUND
Krimi Roga (Intestinal nematode infections)1 is the most common ailment which affect one
fourth to one third of the world’s population. Of these, the Gandupada Krimi (intestinal
roundworm-Ascaris lumbricoides) is the most common. Worldwide, 1.4 billion people are
infected with a lumbricoides. While the vast majority of these cases are asymptomatic, infected
persons may present with pulmonary or gastrointestinal complaints.
The rate of complications secondary to Ascariasis ranges from 11-67%, with intestinal and
biliary tract obstruction representing the most common serious sequelae. Although infection with A
lumbricoides is rarely fatal, it is responsible for an estimated 8,000-100,000 deaths annually,
mainly in children. Ascariasis predominates in areas of poor sanitation and is associated with
malnutrition, iron-deficiency anemia, and impairments of growth and cognition.
Owing to the gravity of the signs, symptoms and rate of complications caused by Ascaris,
it is need to explore and re-establish the efficacy of classical drug Palashbeeja Churna in oral
dosage form to treat the patients affected with Gandupada Krimi (A lumbricoides).
II. OBJECTIVES
1) To see the clinical efficacy of Palashbeeja Churna in the management of Gandupada
Krimi Roga (Ascariasis).
2) Observe the clinical safety of Palashbeeja Churna in the subjects affected by the
Gandupada Krimi (A lumbricoides).
References
1. Charaka Samhita, Vimana Sthana Chapter– 7, Vidyotini Hindi Vyakhya by Vd. Ambikadatta Shastry,
Choukhamba Orientalia, Varanasi
2. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
3. Davidson’s Principles and practice of Medicine, 18th Edition, 1999, Published by Harcourt Brace and
Company, pp173-174
4. Diagnosis and Treatment of diseases in Ayurveda based on Ayurveda saukhyam of Todaranand, Part-II
by Bhagawan Dash & Lalit Kashyap, 1982, pp-286
5. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
87
III. CENTRE
Identified CCRAS Institutes.
Sample size : 40 subjects per centre
Trial Drug /Dosage /Duration : Palashbeeja Churna 750 mg-3 gm
(Dragee form) twice daily before meal for
fifteen (15) days with honey.
Design of the study : Open observational
Total period of the study : 1 year (recruitment of Subjects up to the
end of 6th Month, continuation of trial
therapy till end of 8th Month, last 4
months for compilation of data and
Statistical analysis)
1. Age between 5 to 20 years of either sex.
2. Presence of signs and symptoms caused by A. lumbricoids
3. Positive ova of Ascaris in the stool
4. No history of other parasitic infestation
1. Age less than 5 years and more than 20 years.
2. Negative ova of Ascaris in the stool
3. Other parasitic infestation like hook worm, giardia, EH cyst, etc.
4. Any concomitant disorder of the liver, kidneys, heart, lungs or others
subjects may be withdrawn from the trial.
The full details of screening, history and physical examination of the subjects will be
recorded as per case report form I & II. Clinical and physiological assessment in form III and
88
laboratory investigations in forms IV A, B, C will be done at 0, 8th & 15th days respectively.
Consolidated data on periodical observation will be recorded in case Report form V at 15th day.
IX. CRITERIA FOR ASSESSMENT
Changes in the signs and symptoms and absence of ova of Ascaris will be considered for
assessing the outcome of the treatment on 8th and 15th day. The safety parameters (liver and kidney
function) will be assessed at 0 and 45th day.
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
mail.
analysis.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board if, any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events.
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 8th day, and 15th day. (3 times)
89
90
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Multicentric open Clinical trial of Palasabeeja Churna in Krimi Roga
(Gandupada Krimi)”.
Relationship ___________________________________
91

Krimi Roga (Intestinal nematode infections) is the most common ailment which affect one
fourth to one third of the world’s population. Of these, the Gandupada Krimi (intestinal
roundworm-Ascaris lumbricoides) is the most common. Worldwide, 1.4 billion people are
infected with A lumbricoides. While the vast majority of these cases are asymptomatic, infected
persons may present with pulmonary or gastrointestinal complaints.
The rate of complications secondary to Ascariasis ranges from 11-67%, with intestinal and
biliary tract obstruction representing the most common serious sequelae. Although infection with A
lumbricoides is rarely fatal, it is responsible for an estimated 8,000-100,000 deaths annually,
mainly in children. Ascariasis predominates in areas of poor sanitation and is associated with
malnutrition, iron-deficiency anemia, and impairments of growth and cognition.
Owing to the gravity of the signs, symptoms and rate of complications caused by Ascaris,
it is need to explore and re-establish the efficacy of classical drug Palashbeeja Churna in oral
dosage form to treat the patients affected with Gandupada Krimi (A lumbricoides).
instructions scrupulously. The study will take approximately 15 days. During treatment period,
you are expected to visit the hospital three times i.e. on 0, 8th, and 15th day for clinical and
physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
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BEFORE TREATMENT
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
2. Presence of signs and symptoms caused by A. lumbricoids
3. Positive ova of Ascaris in the stool
4. No history of other parasitic infestation
6. Negative ova of Ascaris in the stool
7. Other parasitic infestation like hook worm, giardia,

EH cyst, etc.
8. Any concomitant disorder of the liver, kidneys,

heart, lungs or others.
93
If admitted, Sr. No. of the Subject: ________________
Date: __________________ Signature of the investigator: ____________________
94
1. Centre: ………………..……….
7. Address: Permanent postal address with phone number & E-mail if any.
..............................................................................................................................................
..............................................................................................................................................
10. Income per capita per month in Rs.: ____________________________
95
12. HISTORY OF PRESENT ILLNESS:
(in days)
a) Jvara (Fever)
b) Vivarnata (Discoloration)
c) Shoola (Abdominal pain)
d) Hridroga(Cardiac disorders)
e) Sadana(Fatigue)
f) Bhrama(Giddiness)
g) Bhaktadwesha (Anorexia)
h) Atisara (Diarrhoea)
i) Swasa krichhrata (Dyspnea)
j) Hrillasa (Nausia)
k) Avipaka (Indigestion)
l) Anaha (Tympanitis)
m) Karshya (Cachexia)
n) Onset of disease Acute (1) Insidious (2)
o) Previous episodes Yes (1) No (0)
p) Duration of disease
q) Treatment given so far: Traditional Medicine (1) Modern Medicine (2)
13. PERSONAL HISTORY Yes (1) No (0)
a) Smoking
b) Non-Vegetarian diet
c) Alcoholic
96
c. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)
Sannipataj (7)
14. PHYSICAL EXAMINATION
a) Built Lean (1) Medium (2) Heavy (3)
b) Gait Normal (1) Abnormal (2)
c) Body weight _________Kg.
d) Body temperature ____________oF
e) Blood pressure (in sitting posture of right upper limb):
Systolic_______mm/Hg Diastolic _______mm/Hg
f) Pulse rate__________/min. (Radial pulse of right upper limb)
g) Respiration rate _________/min.
h) Pallor
i) Jaundice
j) Koilonychia
k) Lymphadenopathy
15. SYSTEMIC EXAMINATION
a) CVS with chest
b) CNS
If abnormal, specify abnormalities_________________________
97
c) Digestive system
d) Uro-genital system
e) Respiratory system
f) Abdomen Palpable (1) Not palpable (2)
i) Liver
ii) Spleen
16. SAMPRAPTI (PATHOGENESIS)
a) Anubandhya dosha
b) Anubandh dosha
c) Avaraka dosha
d) Ksheen dosha
e) Ksheen dhatu Rasa (1) Rakta(2) Mamsa (3)
Shukra(7) Ojas (8)
f) Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)
Shukra(7) Ojas (8)
98
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
(On Day 0, 8th, and 15th)
1. Centre: ………………..……….
3. Sr. No. of the subject: ……………………………........…………………….……………
7. Date of Assessment: .............................................................................................................
(in days)
8. Jvara (Fever)
9. Vivarnata (Discoloration)
10. Shoola (Abdominal pain)
11. Hridroga (Cardiac disorders)
12. Sadana (Fatigue)
13. Bhrama (Giddiness)
14. Bhaktadwesha (Anorexia)
15. Atisara (Diarrhoea)
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16. Swasakrichhrata (Dyspnea)
17. Hrillasa, Chhardi (Nausia, Vomiting)
18. Avipaka (Indigestion)
19. Anaha (Tympanitis)
20. Karshya (Cachexia)
21. Adverse reaction: Present (1) Absent (0)
i. Burning sensation in abdomen
ii. Nausea
iii. Diarrhoea
iv. Skin rashes
v. Any other, specify______________________________________
22. Overall clinical assessment:
Improved(1) No change(2) Deteriorated(3)
Improved(1) No change(2) Deteriorated(3)
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
Date: ______________ Signature of Investigator ___________________
100
(On Day 0)
FORM IV-A – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
Urine Examination
8. Routine: _____________
9. Microscopic: ______________
Stool examination:
10. Routine: _____________
11. Microscopic: ______________
12. Occult Blood: ___________
13. Ova/Cyst (Ova of A.lumbricoids): ____________
Blood
14. TC (Cells/Cmm.) _______________
101
15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
16. ESR (mm / 1st hour.) __________
17. Hb (g/dl) ____________________
18. S. Bilirubin (mg/dl): _____________________
19. SGPT (IU/L) : _____________________
20. SGOT (IU/L) : _____________________
21. S. Alkaline phosphatase (KA unit) : _____________________
22. S. proteins (gm/dl) : _____________________
23. Blood Urea (mg/dl) : _____________________
24. S. Creatinine (mg/dl) : _____________________
Date: _____________ Signature of Investigator __________________________
102
(On Day 08)
FORM IV-B – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
Stool:
8. Ova (A. lumbricoids)/Cyst
103
(On Day 15)
FORM IV-C – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
Urine Examination
8. Routine: _________________________________
9. Microscopic: _________________________________
Stool examination
10. Routine: _________________________________
11. Microscopic: _________________________________
12. Occult Blood: _________________________________
13. Ova/Cyst (Ova of A.lumbricoids) : _________________________________
Blood
14. TC (Cells/Cmm.) _______________
104
15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
16. ESR (mm / 1st hour.) __________
17. Hb (g/dl) ____________________
18. S. Bilirubin (mg/dl) : _________________________________
19. SGPT (IU/L) : _________________________________
20. SGOT (IU/L) : _________________________________
21. S. Alkaline phosphatase (KA unit) : _________________________________
22. S. proteins (gm/dl) : _________________________________
23. Blood urea (mg/dl) : _________________________________
24. S. Creatinine (mg/dl) : _________________________________
105
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
1. Centre: ………………..……….
Sl. Subjective/ objective 0 day/BT 8th day 15th day/AT

No Parameters Dt. Dt. Dt.
1. Jvara (Fever)
2. Vivarnata (Discoloration)
3. Shoola (Abdominal pain)
4. Hridroga (Cardiac disorders)
5. Sadana (Fatigue)
6. Bhrama (Giddiness)
7. Bhaktadwesha (Anorexia)
8. Atisara (Diarrhoea)
9. Swasakrichhrata (Dyspnea)
10. Hrillasa, Chhardi (Nausia,
Vomiting)
11. Avipaka (Indigestion)
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12. Anaha (Tympanitis)
13 Karshya (Cachexia)
14. Adverse reaction
Burning sensation in abdomen
Nausea
Diarrhoea
Skin rashes
Any other
15. TC (Cells/Cmm.)
16. DC P _____% P _____% P _____%
L _____% L _____% L _____%
E _____% E _____% E _____%
M _____% M _____% M _____%
B _____% B _____% B _____%
17. ESR (mm / 1st hour.)
18. Hb(g/dl)
19. Ova(A. lumbricoids) in the
stool
20. Liver function tests
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
21. Renal function tests
Blood urea (mg/dl)
S. Creatinine (mg/dl)
107
Overall clinical assessment
Overall impression of well being by the Subject:
Status of the Subject :
Continuing (1)
Drop out (2) Reason: ______________________________
Died (3) Cause: _______________________________
108
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS
ALONGWITH SAINDHAVA, KALAMI SHORA AND
NAUSADARA IN ONE GROUP VIS-A-VIS PATHAR
CHATTI SWARAS ALONGWITH IKSHUARAKA AND
KALI MIRCH IN THE MANAGEMENT OF
PITTASHMARI (GALL STONE)
Drug: Study Code:

AND SIDDHA
109
Blank
110
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONG WITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONG WITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
I. BACKGROUND
Ayurvedic literature describes ‘Ashmari’ primarily as a disease of urinary tract. Vataj, Pittaj,
Kaphaj and Shukraj these four types of Ashmaris are described in general. No specific etiology or
treatment has been mentioned Pittashmaris. However, the existence of ‘Pitteshu Iva Rochna go’ is
considered Sushruta in Nidana Sthana Chapter III and Chikitsa Sthana Chapter VII describes
Ashmaris etiology and treatment respectively. The entire description belongs to the Ashmaris or
urinary tracts. Gall stones are usually found in the gall bladder, but in 20 percent of cases, stones
may be present in the bile duct. Most of the times, it is the one sone amongst which is
responsible for patient’s sufferings (Bailey & Love’s)1.
The factors responsible for the formation of gall stones may be:
- Metabolic
- Infective
- Bile Stone
The effects and complications of gall stones may be:
(i) Stone in gall bladder
- Silent stones
- Flatulent dyspepsia
- Gall stone colic
- Acute cholecystitis
References
1. Harisson’s Principles of internal medicine, Volume-1, 14 th Edition, International Editions, 1998,
Published by McGraw-Hill Companies Inc .pp1208-1209
111
- Chronic cholecystitis
- Carcinoma
(ii) In the bile ducts
- Obstructive jaundice
- Acute/recurrent poncreatitis
- Cholangitis
(iii) In the intestine
- Acute intestinal obstruction
TYPE OF GALL STONES
The gall stones may be:
- Cholesterol
- Pigment stones (12% of gall stones)
- Mixed stones (majority 80-82% of gall stones)
A fat fertile, female of forty is an easy victim to the disease.
The incidence of gall-stone rises with diabetes mellitus, raised serum triglycerides,
pregnancy, obesity, patients taking clofibrate, oestrogen replacement therapy and contraceptive
pills. Patients with cirrhosis liver and hemolytic anemia have more chances of pigment stones.
Modern therapy advocates surgery/lithotripsy in most of the cases. However
chenodeoxycholic acid (10-15 mg./Kg./day) or Ursodeoxycholic acid 8-10 mg./Kg./day) may be
given to dissolve gall stone in 50-70% of the cases within 2 years. Recurrence can occur on
discontinuation of the therapy.
The patient of cholelithiasis-cholecystitis may present as acute cholecystitis or chronic
cholecystitis. The patients to be taken for Ayurvedic research may be of chronic cholecystitis.
II. OBJECTIVE
No significant contribution has been made to the treatment of Pittashmari (Gall Stone) in
Ayurvedic science, yet there are different claims. It has been considered worthwhile to find out the
effect of some claimed and popular Ayurvedic medicines, practiced to remove stone. The present
study is launched with a view to:
Study the disease incidence, Clinical picture and disease pattern of Pittashmari (Gall
Stones).
112
See the effect of Vijaura Nimbu swaras + saindhava + Kalami Shora + Nausadara + Ela
combination of radiologically/ultrasonographically proved cases of Pittashmari (Gall Stone).
See the effect of Pathar Chatti swaras + Ikshuraka Kshara + Kali Mirch in the diagnosed
cases of Pittashmari (Gall Stone)
To study comparatively the effect of treatments in group (ii) and (iii).
III. CENTRE :
CCRAS identified Centres
No of Groups: 2
No of patients in each group: 20
(Patients to be randomly allocated to different treatment groups)
Treatment:
Group I: Vijaura Nibu swarasa — 750 ml.
Saindhava — 20 gm.
Kalami Shora — 10 gm.
Nausadara — 10 gm.
Ela — 10 gm.
Mixed and filtered — 20 ml. thrice a day for 30 days
Group II: Pathar Chatti swarasa — 10 ml

Ikshuraka Kshara — 1 gm.
Kali Mirch — 4 in number
(1 such thrice daily with water) for 30 days)
Type of Study: Single blind
Period of Study: 30 days
Follow up; For a period of 3 months on a regular interval of two weeks
113
V. CRITERIA OF INCLUSION
1) Age > 10 years < 60 years
2) Sex-either-sex
3) Chronicity: Disease note older more than 5-7 years.
4) Murphy’s sign: Pain/Catch in deep breath when the fingers are pressed below right coastal
cartilage.
5) Patients of chronic cholecystitis/silent gall stones
6) Obese/non-obese
7) High lipid/normal lipid
8) Clinical feature of chronic cholecystitis with positive murphy’s sign.
9) Gall stone observed by definite investigative procedures e.g.
- Plain X-ray abdomen
- Oral cholecystogram
- Ultrasonography
- Endoscopic retrograde cholangiography and percutaneous hepatic cholangiography
VI. CRITERIA OF EXCLUSION

1. Acute cholecystitis
2. Acute pancreatitis
3. Carcinoma of gall bladder
4. Biliary enteric fistula
5. Diabetes mellitus
6. Pregnancy
7. Severe pain/fever/typhoid
8. Persistent
9. Jaundice
10. Empyema/septicaemia/shock
114
11. Patients on steroids
12. Patient with polyarteritis
VII. CRITERIA FOR WITHDRAWAL:
1. Discontinuation of treatment during the trial
2. Development of any complications
3. Aggravation of the disease symptoms
4. Any side effect of the drug
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations- urine routine and
microscopic, stool examination, blood sugar fasting & pp, lipid profile, x-rays: plain x-ray
abdomen, oral cholecystogram, ultrasonography,endoscopic retrograde, cholangiography will be
recorded before drug administration, at the end of treatment (Form-III)
Assessment will be done as per proforma after 3 months of regular treatment as per the
proforma. However, the patients are to be reviewed after every two weeks.
1. Good Response: Complete disappearance of signs and symptoms with no complications
and considerable regression in the size of the stone/complete disappearance of the stone.
2. Fair response: 50% and above relief in symptomatology with some regression in the size
of the stone.
3. Poor response: 25% and above relief in symptomatology with no change in the size of the
stone.
mail.
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
115
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centers should give clearance
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.
116
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I, exercising my free power of choice, hereby give my consent to be included as
a subject in the clinical trial on evaluation of vijaura nibu swaras alongwith saindhava,
kalami shora and nausadara in one group vis-a-vis pathar chatti swaras alongwith
ikshuaraka and kali mirch in the management of pittashmari (gall stone).
Relationship ___________________________________
117

Research is going on to find a suitable natural product for the treatment of Pittashmari (Gll
stone). You are invited to participate in such a study in which you will receive either Ayurvedic
trial drugs or control drug for 30 days.
The aims of the present study are
• To see the effect of Vijaura Nimbu swaras + saindhava + Kalami Shora +
Nausadara + Ela combination of radiologically/ultrasonographically proved cases of
Pittashmari (Gall Stone).
• See the effect of Pathar Chatti swaras + Ikshuraka Kshara + Kali Mirch in the
diagnosed cases of Pittashmari (Gall Stone)
• To study comparatively the effect of treatments in group (ii) and (iii
• Total 100 patients from this and other hospitals will be taking part in this study.
instructions scrupulously. The study will take approximately six months to complete. After this
period, you are expected to visit the hospital every fortnight. The interval between the first and
second visit will be around 15 days.
physical examination. ECG, Blood and urine samples will also be taken. This is to make sure that
you are eligible for the study.
One week later, at your second visit, if you are eligible, you would be put on trial treatment
for 30 days. You may receive either trial drug or control drug for 30 days. You should follow life
style modifications (Diets Advice, Exercise) as given along with information Sheet
From the first visit onwards, you will be required to fast overnight before attending each visit.
Blood and urine samples will be taken at every visit. At each visit, you will be supplied with
sufficient quantity of drug to last until your next visit.
118
What happens at the end of the study?
The trial treatment will be stopped at the end of 30 days. You will be put back on an
appropriate treatment available in the market.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment.
When you can leave the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
119
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE).
BEFORE TREATMENT
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
1. Patient of chronic cholecystitis/Silent gall stone
2. Clinical features of chronic cholecystitis
3. Murphy’s sign positive
4. Chronicity < 5 – 7 years
5. Age > 10 yrs. < 60 yrs.
6. Sex – either sex
7. Obese/Non-obese
8. High lipid/Normal lipid
120
9. Acute cholecystitis
10. Acute pancreatitis
11. Carcinoma of gall bladder
13. Pregnancy
14. Colic/Typhoid/Jaundice
15. Biliary enteric fistula
16. Empyema/Septicaemia/Shock
17. Patient on steroids
18. Patients of polyarteritis
If Sl. No. 1-8 is ‘Yes’ and Sl. No. 9-18 are ‘No’
Date: ………………….. Signature of the Investigator: ………………………
121
1. Centre: ………………..……….
3. Name of the patient …………………………….....……… Age ………… Sex ………...
4. Address : ..............................................................................................................................
5. Date of Admission : Date of Discharge :
6. Group No. First (1) Second (2)
Third (3) Fourth (4)
9. Total income of the family (in Rupees)
Total family members:
Income per capita per month (in Rupees)
122
10. Religion Hindu (1) Muslim (2) Christian (3)
Parsi (4) Others (5)
11. Marital status Married (1) Unmarried (2) Divorcee/ (3)

separated
CHIEF COMPLAINTS WITH DURATION (IN MONTHS)
Present (1) Absent (0) Duration
12. Pain abdomen
13. Dullache in Present hypochondrium
14. Distension (abdomen)
15. Fullness belching/retching
16. Nausea
17. Fever
18. Jaundice
HISTORY OF PRESENT ILLNESS
19. Onset of disease Acute(1) Insidious (2)
20. Duration of disease(in months)
21. Factors aggravating the disease/chief complaints: ……….……………………………….....

..........……………………………………………………………………….……………
22. Factors relieving main complaints ………………………………………………………….

..........………………………………………………………………………………………
23. History of past illness, having relation with present illness
Yes (1) No (0)
If yes, specify…………………………………………………………….........……………
H/o Pancreatitis/Liver disease/Typhoid/Lipid disorders/Obesity
H/o Operation
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H/o Treatment-hepatotoxic drugs/oestrogens/steroids
FAMILY HISTORY IF ANY
Yes (1) No (0)
24. Carcinoma
26. Polyarteritis
27. Liver disease
28. Obese/Lipid disorders
If yes specify……………………………………......….…………………………………….
PERSONAL HISTORY
29. Diet Veg (1) Non-veg (2) Lacto-ova Veg (3)
30. Sleep Good(1) Disturbed (2) Insomnia (3)
31. Emotional Stress Yes (1) No (0)
If yes, specify………………………………………………………………………............
33. Sharirika Prakriti: Vataaj (1) Pittaj (2) Kaphaj (3)
Vataja-Kaphaj(4) Vataj-Pittaj (5) Pittaj-Kaphaj (6)
Sannipataj (7)
34. Manas Prakriti Sattava (1) Rajas (2) Tamas (3)
Sattava Rajas(4) Sattava Tamas(5) Rajas Tamas (6)
Sama (7)
124
37. Body weight (in Kg.)
38. Blood pressure (Systolic)
39. Blood pressure (Diastolic)
40. Pulse
41. Respiration rate
42. Anaemia Present (1) Absent (0)
43. Jaundice Present (1) Absent (0)
44. DIGESTIVE SYSTEM
P/A – Soft Yes (1) No (0)
Non-tender
Liver Yes (1) No (0)
Palpable
Tender
Gall Bladder Yes (1) No (0)
Palpable
Tender
Spleen Yes (1) No (0)
Palpable
SYSTEMIC EXAMINATION Normal (1) Abnormal (2)
45. C.V.S. (With Chest)
If abnormal, specify abnormalities……………………………………….............…………..
46. C.N.S
If abnormal, specify abnormalities………………………………………………...............
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If abnormal, specify abnormalities…………………………………………………..
48. Uro-Genital system
SAMPRAPTI (PATHOLOGENESIS) OF THE DISEASE ACCORDING AYURVEDIC

CONCEPT
50. Dosa Vata (1) Pitta (2) Kapha (3)
51. Dushya (Involved) Rasa (1) Rakta (2) Mamsa (3)
Shukra (7) Ojas (8)
52. State of disease (Roga Kriya Kala)
Sanchaya(1) Prakopa(2) Prasar (3)
Sthansamshraya (4) Vyakti (5) Bheda (6)
RAKTA VAHA SROTAS Yes (1) No (0)
Pidika
Rakta Pitta (Bleeding)
Mukhapak
Vidradhi (Abcess)
Kamla
PURISHA VAHA SROTAS Yes (1) No (0)
Atibadha Purisha
Atidhrava Purisha
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Scantly stool
Excessive faecal matter
Painful defecation
Increased frequency of defecation
LAB INVESTIGATION
Microscopic
1. Urine
Routine
2. Blood
(i) Hb%
(ii) TLC
(iii) DLC
(iv) ESR
BIOCHEMICAL
Microscopic
(1). Urine
Routine
(ii) Lipid profile
(iii) HDL
(iv) LDL
(v) VLDL
(vi) S. CHOLESTEROL
(vii) Serum Triglycerides
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X-RAY
(i) Plain X-ray abdomen
(ii) Oral cholecystogram
(iii) Ultrasonography
(iv) Endoscopic retrograde cholangiography
Provisional Diagnosis
Final Diagnosis
Medical Management
Principal Drug Therapy
Dose
Vehicle
Diet
Summary of findings
Results Good Response (1) Fair Response (2)
Poor Response (2) No Response (4)
Drop out (5) LAMA (6)
Date: ……………… Signature of the Investigator: ………………………...
128
CASE REPORT FORM III– CLINICAL ASSESSMENT
1. Centre: ………………..……….
3. Name of the patient …………………………….....……… Age ………… Sex ………...
4. Address : ..............................................................................................................................
5. Date of Admission : Date of Discharge :
Third (3) Fourth (4)
CLINICAL PARAMETERS
(A). SUBJECTIVE YES (1) NO (0)
Pain abdomen
Fullness/belching/wretching
Nausea/Vomiting
Fever
Dullache in right hypochondrium
Abdominal distention/epigastric discomfort
(B). OBJECTIVE YES (1) NO (0)
Jaundice
Hyprochondriac tenderness
Date: _____________ Signature of the Investigator: _______________
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CASE REPORT FORM IV – LABORATORY INVESTIGATION
1. Blood Sugar: Fasting
Post Prandial
2. E.S.R.
3. Lipid Profile
- HDL
- LDL
- VLDL
- S. Cholesterol
- Serum Triglycerides
4. X-RAYS Before treatment After treatment
- Plain X-ray abdomen
- Ultrasonography
- Oral Cholecystogram
Date: ______________ Signature of the Investigator: ______________________
130
CLINICAL STUDY ON SERO CONVERSION OF HBs
Ag (CARRIERS) WITH CODED AYURVEDIC
FORMULATION ‘AYUSH-LIV’
Drug: Study Code:

AND SIDDHA
131
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132
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’
I. BACKGROUND
Hepatitis B1 is one of the major diseases of mankind and is a serious global public health
problem. It is preventable with safe and effective vaccines that have been available since 1982.
Hepatitis B Virus (HBV) is the most versatile of the hepatotropic Viruses. HBV can produce (1)
Acute hepatitis (2) Chronic non progressive hepatitis (3) Progressive chronic disease ending in
cirrhosis (4) Fulminant hepatitis with massive liver necrosis and (5) an a symptomatic carrier with
or without progressive disease. It has been documented by the WHO that world wide, there are
over 400 million hepatitis ‘B’ carriers, of which 42 million are in India alone. These carriers are at
200 times greater risk of developing serious liver complication including cirrhosis and liver cancer.
An HBV carrier is one who had hepatitis B in his blood for more than six months. A
carrier usually has no signs or symptoms of HBV but remains infected with the virus for years or
for a life time and is capable of passing the disease on to others. Sometimes HBV carriers will
spontaneously clear the infection from their bodies, but most will not. Any one who has not cleared
the virus after six months and has elevated liver enzymes is considered to have chronic hepatitis.
This means, the virus is infecting living liver cells and damaging them. Scar tissue called cirrhosis
replaces the damaged cells. The build up of Cirrhosis causes the liver to become hard and bumpy
and distorts the blood flow through this vital organ.
Characteristics of a HBs Ag Carrier state:
Carriers usually have no history of acute hepatitis and no clinical features of liver disease.
All of them have HBs Ag in blood. Some have HBe Ag and Anti HBe. Most of them have
normal liver function tests. Prognosis is uncertain. Virus can be carried for years. Some develop
chronic hepatitis and others are at increased risk of developing cirrhosis and hepato cellular
carcinoma.
Transmit ion of infection:
Hepatitis B Virus is transmitted by contact with blood or body fluids of an infected person
in the same way as human immuno-deficiency Virus (HIV). However HBV is 50 to 100 times
more infectious than HIV.
References
1. Harrison’s Principle of Internal Medicine 15th Edition
133
The Hepatitis B Virus (HBV) gets transmitted through
1. Prenatal (From mother to baby at the birth)
2. Child to child transmission
3. Unsafe injections and transfusions
4. Sexual contact
Hepatitis B virus is not spread by contaminated food or water and cannot be spread
casually in the work place.
Viral markers:
Chronic HBV infection is marked by the presence of HBs Ag) in the blood. At times the
Hbe Ag and Anti Hbe is also present. Presence of Hbe Ag indicates active viral replication.
Presence of Anti Hbe implies that replication is occurring at much lower level or that viral DNA
has become integrated into host Hepatocyte DNA.
PCR: Polymerase chain reaction can show HBV DNA in the blood, implying that viral
replication is occurring. This is essentially needed for formulating the treatment protocol..
Based on serological markers, hepatitis B carriers are classified into two categories super
carriers and simple carriers.
Super carrier: Those who have HBe Ag in their blood and are in the early stage of the
carrier state are very highly infectious. Very minute amount of serum or blood from such carriers
can transmit the infection. They have high titres of HBs Ag and DNA Polymerase in their blood.
Simple carrier: Very common type with no HBe Ag and a low level of HBs Ag in the
blood. HBV DNA Polymerase is negative. Simple carrier transmits the infection only when large
volumes of blood or serum are transferred as in blood transfusion. Simple carrier represents the
later stage of the carrier state.
Interferon is one of the drugs of choice for use in Chronic hepatitis B infection. Clinical
utility of interferon is limited by substantial adverse effects such as Flu like symptoms. Fatigue,
visual disturbances, Neuro toxicity, Neutropenia , Hypo tension etc.
As per Ayurvedic texts several plant drugs are known for its hepato protective, anti
hepatotoxic and anti-viral properties. A coded drug Ayush-Liv with four herbal ingredients having
above mentioned properties is selected to explore the possibilities of these drugs in combination in
the clearance of Hepatitis-B Virus.
II. OBJECTIVES
1. To study the efficacy of the Ayush-Liv formulation to get the viral marker, Hbs Ag sero
negative.
134
2. To study the efficacy of Ayush-Liv formulation in maintaining the liver parameters within
normal limits.
III. CENTERS
Sample size: 30 cases
Type of Study: Open trial
Trial Drug /Dosage /Duration
Group I - Allopathic drug + placebo (60 days)
Group II - Allopathic drug + AYUSH-LIV (two Caps, 550mg each twice
a day after food with water).
Type of study : Placebo controlled study
Period of study: Two months for each case and Post study surveillance screening
for one month. Total duration will be two years to complete the
study.
Follow Up : One follow up will be carried out after three months of completion
of the treatment.
1. Age between 18-60
2. HBs Ag positive in blood (Eliza test)
3. Normal liver function test [Serum bilirubin total<1 mg, Serum bilirubin direct <0.2mg,
Serum bilirubin indirect) <.0.8mg, SGOT<=40, SGPT<=40, SAP<13 KA Unit
4. Total protin <5.6>8.5 gm,
5. Albumin >4<6.7 gm
6. Total Globulin >1.2<2.9 gm
1. Age below 18 and above 60 years.
2. Viral markers positive for Anti HBc (IgG,IgM) Anti HBs, HBeAg, anti HBe
3. History of Jaundice during last two years
135
4. Abnormal Hematological cell count
5. Drug addicts
6. Alcohol addicts
7. Serum bilirubin total>1 mg, Serum bilirubin direct>0.2mg, Serum bilirubin
Indirect >.0.8 mg., SGOT>40 , SGPT>40, SAP>13 KA Unit
8. Total protein >5.6<8.5 gm,
9. Albumin <4>6.7 gm
10. Total Globulin <1.2>2.9 gm
i) If any increase in LFT parameters is observed in subsequent investigations the case will be
withdrawn.
ii) A case will be withdrawn from the study if there is development of any major ailments or
clinical symptoms of Jaundice.
iii) Patients failure to report for follow up or irregular medication (discontinuation for seven
days or above)
Patients withdrawn from the study will be managed by the Investigators.
VIII. ROUTINE EXMINATION AND ASSESSMENT
The full details of history and physical examination of patients will be recorded as per the
Proforma (Form I &IA). Clinical assessment will be done before drug administration, every
fortnightly till the completion of the treatment. The laboratory investigations will be recorded before
drug administration, every month till the end of treatment and at the end of follow-up. [Form III].
Eliza Test for HBs Ag : Every month and at the end of follow-up
Anti HBc, anti HBs : At the time of inclusion
Hbe Ag and anti HBe
LFT : Before treatment and every month till the end of
treatment and at the end of follow-up.
If HBs Ag becomes sero negative during treatment or after completion of the treatment it
will be considered a successful outcome of the treatment. 40% difference in the success rate
between the placebo ant the treatment group will be considered significant outcome.
136
X. STATISTICAL ANALYSIS
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS
analysis.
XII. ETHICAL REVIEW
B. Data and safety monitoring board: A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
A consolidated amount of Rs.……. /- per visit will be paid to subject.
137
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial on healthy carriers of hepatitis ‘B’ with herbal compounds.
Relationship ___________________________________
138
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV

Hepatitis ‘B’ virus (HBV) is the most Versatile of the hepato tropic viruses. It can
produce acute or chronic; progressive or non progressive hepatitis and exists in a carrier state
permanently with or without progressive disease. It has been documented by the WHO that
world wide there are over 400 million hepatitis ‘B’ carriers of which 42 million are in India alone.
These carriers are 200 times greater risk of developing serious liver complication including cirrhosis
and liver cancer. As per Ayurvedic literature several plant drugs are known for its hepato
protective, anti hepato toxic and antiviral properties. So a few drugs such as Katuki (Piccrorhiza
kurroa), the present study is aimed to evaluate role of selected Ayurvedic drugs in clearance of
Virus B infection in healthy carriers. You are invited to participate in this study where you will be
provided this drug. The previous observations in clinical and experimental studies have shown
promising effect of these drugs in the treatment of Viral Hepatitis. About 100 healthy carriers from
this hospitals and cases referred from other hospitals will be taking part in this study.
instructions scrupulously. The study will take approximately three months to complete (two months
for treatment and another one month for follow-up study). During this period, you are expected to
visit the hospital three times. The interval between the first, second and third visit will be one
month.
Before you start treatment, during the first visit to the OPD, you will undergo a complete
physical examination, Blood and urine samples will also be taken and also tested for all the viral
markers for Hepatitis ‘B’. This is to make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for two months. The daily
dosage will be two Caps of 550mg each twice daily. At each visit, you will be supplied with
sufficient quantities of drugs to last until your next visit.
139
BEFORE TREATMENT
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
CRITERIA FOR SELECTION Yes (1) No (0)
1. Age between 18-60
2. HBs Ag positive in blood (Eliza test)
3. Serum bilirubin total<1 mg
4. Serum bilirubin direct <0.2mg
5. Serum bilirubin indirect) <.0.8mg.
6. SGOT<=40 mg
7. SGPT<=40 mg
8. SAP<13 KA Unit
9. Total protin <5.6>8.5 gm
10. Albumin >4<6.7 gm
11. Total Globulin >1.2<2.9 gm
140
13. Anti HBc Positive
14. Anti HBs Ag Positive
15. Anti HBeAg Positive
16. HBe Ag Positive
17. History of Jaundice during last two years
18. Hematological cell count
19. Drug addicts
20. Alcohol addicts
21. Serum bilirubin total>1 mg
22. Serum bilirubin direct>0.2mg
23. Serum bilirubin indirect >.0.8mg
24. SGOT>40 mg
25. SGPT>40 mg
26. SAP>13 KA Unit
27. Total protin >5.6<8.5 gm,
28. Albumin <4>6.7 gm
29. Total Globulin <1.2>2.9 gm
30. Cases undergoing treatment for any

other serious illness
If Sl.No.1 – 11 is ‘YES’ and Sl.No.12 – 30 are ‘No’
If admitted: Subject’s Serial No. __________ No. of packets issued: ___________
Date: ____________ Signature of the Investigator: ______________________
141
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
Housewife (3) Others (4)
10. Income
Total Members in the family : ___________________________________________
Total Income in the family : ___________________________________________
Per capita income : ___________________________________________
142
History of Past Illness Yes (1) No (0)
11. Jaundice
12. Major or minor surgery With blood transfusion
If yes, indicate amount of blood transfusion _____________________
13. I.V. Fluids
Any injection
14. Intramuscular
If yes, indicate number of injections taken_______________________
15. Intravenous
If yes, indicate number of injections taken_______________________
16. Any history of drug abuse
If yes, provide details about drugs and mode of consumption _______
17. Previous treatment for Jaundice
If yes, provide details regarding time and period of illness__________
Personal History
18. Marital status Married (1) Unmarried (2) Widow (3)
Widower (4) Divorced (5)
19. Sexual orientation Heterosexual (1) Homosexual (2)
Bi-sexual (3) Others (4)
Addiction
20. Alcohol No (0) Yes (1)
If yes specify (a) Quantity per week (ml) ______________
143
21. Any other, specify: ___________________________________________________
22. Height (cm) ____________

23. Weight (kg) ____________
24. Pulse (per min) ____________
25. Blood Pressure Systolic(mm Hg)____________
26. Blood Pressure Diastolic (mm Hg) ____________
27. Respiration rate( per min) ____________
Systemic examination Normal (1) Abnormal (2)
28. CVS
If abnormal details___________________________________________
If abnormal, details ___________________________________________
30. CNS
Clinical Symptoms Absent (0) Present (1)
33. If any
If Present, specify____________________________________________
No. of packets issued: _______________________________________
Date:____________ Signature of the Investigator: ______________________
144
PROTOCOL FOR CLINICAL STUDY ON HEALTHY CARRIERS OF
HEPATITIS ‘B’ WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
(0th, 1st & 2nd Month)
CASE REPORT FORM III – CLINICAL ASSESSMENT
1. Centre: ………………..……….
7. Date of Assessment:
8. Period of Assessment: Initial (0) 1st Month (1) 2nd Month (2)
CLINICAL ASSESSMENT Yes (1) No (0)
9. Fever
10. Anorexia
11. Nausea
12. Vomiting
13. Yellow tint of the sclera
14. Dark coloured urine
15. Clay coloured stools
16. Malaise
Date: __________ Signature of the Investigator__________________
145
(CARRIERS) WITH CODECD AYURVEDIC FORMULATION AYUSH-LIV
(0, First & Second Month)
CASE REPORT FORM IV– LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
8. Period of Assessment: Initial (0) 1stMonth (1) 2ndMonth (2)
Urine Examination (Microscopic)
9. Sugar: ___________________
10. Albumin: ___________________
11. Deposits: ___________________
Blood
12. TLC (Cells/Cmm.)_____________________
13. DLC: P (%)________ L (%)________ E (%)________M (%)________ B (%)________
14. Hb(g/dl): ________________
15. ESR (1st hour.)(m.m.): ________________
16. Blood Sugar-Fasting (%): ________________
146
17. Blood Sugar – PP (mg. /dl): ________________
18. S.Cholesterol (mg./dl): ________________
19. HDL (mg. /dl): ________________
20. LDL (mg. /dl): ________________
21. Triglycerides (mg. /dl): ________________
22. B. Urea (mg. /dl): _______________
23. S.creatinine (mg. /dl): _______________
24. Urea (mg. /dl): _______________
25. SGOT: _______________
26. SGPT: _______________
27. Serum bilirubin tota: _______________
28. Serum bilirubin direct (mg) _______________
29. Serum bilirubin indirect (mg.) _______________
30. Alk.Phosphatase(KA units) _______________
31. Total protin ( gms) _______________
32. Albumin (gms) _______________
33. Total Globulin (gm) _______________
34. HBsAg _______________
Physiological Parameters
35. Systolic Blood Pressure (mm of Hg) ____________________
36. Diastolic Blood Pressure (mm of Hg) ____________________
37. Weight (Kg) ____________________
38. Any other Remarks
Date: ____________ Signature of the Investigator: ____________________
147
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148
JOINT DISORDERS
SECTION - III
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150
COMPARATIVE CLINICAL EVALUATION OF
PHANCHKARMA VERSUS PHYSIOTHERAPY IN
PATIENTS OF SANDHIVATA (OSTEOARTHRITIS) -
KNEE JOINT
Drug: Study Code:

AND SIDDHA
151
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152
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
I. BACKGROUND
Panchakarma is a textual classical and authentic treatment procedure of Ayurveda. Our
ancient sages and scholars like Charaka and Vagbhatta have attributed a lot of potential benefits
to Panchkarma practices. The aim of the study is to see the effect of Panchakarma in group I
patients of Sandhivata (Osteoarthritis) and to compare the results with known physiotherapy
treatment in the patients of group II. This Physiotherapy treatment is usually referred to by doctors
of various Systems of Medicines1.
II. OBJECTIVE
Comparative clinical evaluation of Panchkarma versus Physiotherapy in patients of
Sandhivata (Osteoarthritis) - knee joint, with selected clinical parameters.
III. CENTRES
CCRAS identified centers
Type of study : Open trial
Level of study : OPD/IPD
Number of Groups : Two Groups
Sample Size : 30 (15 patients in each group)
References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chikitsa Sthana, Chapter – 28,
Chaukhambha Sanskrit Sansthan, 5th edition, Varanasi, 2001
2. Clare Jinks, Kelvin Jordan Measuring the population impact of knee pain and disability with the
Western Ontario and McMaster Universities Osteoarthritis Index. Pain 2002: 100, 55-64.
3. Gail D Dyele, Stephen C Allison, Robert L Matekel. Physical Therapy treatment effectiveness for
osteoarthritis of the knee: A randomized comparison of supervised clinical exercise and manual therapy
procedures versus a home exercise program. Physical Therapy 2005: 85, 12, 1301-1317.
4. Effects of repetitive shortwave diathermy for reducing synovitis in patients with knee osteoarthritis: An
ultrasonographic study Physical therapy 2006: 86, 2, 236-244.
153
Drug/Dosage/Duration:
Group-I Panchkarma Group:
• Local application of Pancaguna Taila 10-15 ml each joint, thrice a day
• Nadi Sweda with Dashmoola Kwatha for 15 minutes, followed by rest for 15
minutes.
The above mentioned Panchkarma treatment will be given for 4 weeks in the hospital
followed by 2 weeks Pancaguna Taila application at home.
Group-II Physiotherapy Group:
• Exercise Protocol for 4 weeks continuously in the hospital which will consist of
Manual Therapy, Stretching, Strengthening, and Range of Motion Exercises, followed
by exercises at home for another 2 weeks.
• Associated with above treatment, shortwave diathermy (a type of thermal therapy) for
initial 2 weeks (6 days/ week).
Duration of treatment : 4 weeks in both the groups
Follow up period : After 2 wks
2. Sex-Either sex
3. Patients with Primary Osteoarthritis – knee joints (single or both knees)
4. Kellgren Lawrence (Radiological scale) of e” 2.
Note: Patients taking Ayurvedic/Allopathic NSAIDs orally may be included in the study but the
treatment may be considered as basal treatment and it should not be altered during the trial.
1. Age less than 40 years or more than 70 years.
2. Patients with skin allergies/skin diseases
3. Patients with Pott’s spine/infections/other systemic diseases
4. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic
Arthritis, SLE.
5. Patients with Diabetes/Hypertension
154
6. Bed ridden patients
7. Patients using local Anti-inflammatory medicine other than the research drugs.
8. Patients taking active Allopathic/Homeopathic treatment.
9. Low backache with or without radiation to legs.
10. Patients with metallic implants.
11. Subjects having any deformity of knee, hip or back.
12. History of bony or soft tissue injury to knee joint.
During the course of treatment, if any serious condition or any serious adverse events
occurs or pain/stiffness/swelling increases, or if subject himself/herself wants to withdraw from the
study, such subjects may be withdrawn from the study.
VIII. ROUTINE EXAMINATION/ASSESSMENT:-
Inclusion into study - 0 day
1st assessment - 14th day
2nd assessment - 28th day
3rd assessment - 42nd day
Assessment Chart – annexed in case record form.
(Based on visual analogue scale).
Radiography-I
To diagnose the patients (at or before day 0) at the time of inclusion.
Radiography-II
To be compared with Radiography-I at the time of final assessment i.e. 45th day.
However much radiographical changes are not expected.
Result expectations:
30 to 35% improvement is expected in treatment groups.
However 10 to 20% improvement may also be there in placebo group.
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
155
X. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XI. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
Counseling about life style:-
During the research period, the patient should maintain uniform life style or basal life style
(what he was adopting in general). Over exercise, over strain, riding bicycle, going upstairs or
sitting in squatting positions may seriously alter the results.
156
To Check the drug compliance
The packing of the oil should be proper with no mark over the bottle so as to avoid bias.
At each visit, patient must bring his/her medicine bottle and submit it to the researcher so that the
consumption of medicine may be checked.
Expected medicine requirement for 42 days
Oil requirement for 6 weeks (42 days):
One application on one joint = 10-15 ml x 3 times a day
= 30-45 ml.
In case of two joint involved 60 - 90ml per day.
Let us take average of 50ml per day per patient.
Thus total oil requirement for 42 days for 15 patients will be = 50 x 42 x 15
= 32 liters
Medicine requirement for 4 weeks (28 days):
Dashmoola required per day per patient = 50 gms
Requirement for 28 days for 1 patient = 50 x 28
= 1400 gms
Thus total medicine required for 28 days for 15 patients = 50 x 28 x 15
= 21kg
PHYSIOTHERAPY TREATMENT
1. Patient Exercise Program: Strengthening Exercises
Exercise Performance Repetitions

Static quad Perform daily Hold each contraction for 6 s
sets in knee Patient is positioned fully supine or with a
extension supine supported on elbows with the 10-s rest between repetitions
knee in full extension. Patient contracts Repeat 10X
the quadriceps femoris muscle and
pushes the knee down while maintaining
the foot in full dorsiflexion.
157
Standing Perform 3 X per week Hold each contraction for 3 s.
terminal knee Patient stands with a resistive band or a Repeat 10X
extension cuff from a weighted pulley mechanism Increase resistance as
behind a slightly flexed knee. Patient tolerated
contracts the gluteal and quadriceps
femoris muscles to fully straighten the hip
and knee
Closed-chain Patient performs one of the following

progression, activities 3X per week.
ordered from Patient should progress to the most
least to challenging activity that he or she can
mostchallen- successfully complete with minimal or no
ging pain
1. Seated Patient is seated holding a resistive band Hold each contraction 3 s

legpresses in both hands. Patient places his or her with knee as straight as
foot against the band, then straightens possible. Slowly return to
the knee by pushing the foot down and starting position and repeat for
forward by contracting the gluteal and a 30 s bout.
quadriceps femoris muscles Progress to bands of
increasing resistance and
additional bouts
2. Partial Patient stands with arm support as Hold each contraction 3 s

squats weight needed with hips and knees as
lessenedwith Patient performs a partial squat, keeping straight as possible. Repeat for
arm support the knees centered over the feet. Return 30 s Progress to full body
as needed to standing by contracting the quadriceps weight without
femoris and gluteal muscles support and additional bouts
3. Step-ups Patient stands in front of a low step. Slowly repeat for 30 s

Patient places foot of involved leg on Progress to increased height of
step and brings body over foot to stand the step and additional bouts.
on the step. Use as little push-off Alternate legs if both knees
assistance from the contralateral foot as are involved
possible. Step down with the
contralateral foot
158
2. Patient Exercise Program: Stretching Exercises
Standing calf Perform daily Hold for 30 s and repeat 3X

stretch Patient stands with the heel of the foot
on the ground behind the patient; the
toes point straight ahead. The patient
leans forward until a moderate pull is
perceived in the calf musculature. The
patient may use his or her arms for
support against a wall or furniture as
needed
Supine Perform daily Hold for 30 s and repeat 3X

hamstring Patient is positioned supine with the Clinical observation: if
muscle stretch contralateral lower extremity maintained radicular symptoms are
as straight as possible. The ipsilateral hip produced, decrease or
is flexed to 90° eliminate the ankle dorsiflexion
The knee is straightened and the or the intensity of the stretch
proximal lower leg supported with the
hands until a moderate pull is perceived
in the posterior thigh and calf The
ipsilateral ankle should be dorsiflexed
Prone Perform daily Hold for 30 s and repeat

quadriceps Patient is positioned prone with both 3XClinical observation:
femoris hips and knees. A strap is placed around hamstring muscle cramping
muscle stretch the ipsilateral ankle and brought may occur if the patient
posteriorly and superiorly over the attempts to actively bend the
ipsilateral shoulder. The patient grasps knee; to reduce this possibility,
the strap in the ipsilateral hand and always use the strap to
bends the knee by straightening his or passively flex the knee
her elbow and pulling on the strap. The Maintain a gentle stretch and
knee is progressively flexed until a gentle comfortable position for the
stretch is perceived in the anterior thigh lumbar spine. Hard stretching
will frequently create lumbar
symptoms in this population
159
3. Patient Exercise Program: Range of Motion Exercises

Knee in mid- Perform daily Two 30-s bouts with 3-s hold
flexion to full- Performed once daily at end range
extension Patient is positioned supine or supine Clinical observation: these
supported on elbows Knee is brought exercises work best if
to 45° of flexion with the ipsilateral foot performed on a smooth
sliding on the surface that the patient is surface such as a hardwood
lying on. The knee is then fully extended or linoleum floor or if a sliding
with a strong quadriceps femoris muscle board is used
contraction against any limitation to full
knee extension.
Knee in mid- Performed once daily Two 30-s bouts with 3-s hold
flexion to full- Patient is positioned supine or supine at end range.
flexion supported Clinical observation: pain with
on elbows Knee is brought to full flexion end-range knee flexion may
with assistance of the upper extremities be due to degenerative
or a strap A gentle challenge to end- meniscal tears
range flexion is sustained. Over-pressure to end range
should be applied with
caution.
Stationery Performed once daily 5 min, increase time as

bicycle Knees should be at nearly full extension tolerated
at bottom of pedal stroke Clinical observation: some
patients are intolerant of the
stationary bicycle, and clinical
judgment is required to
continue the activity.
160
4. Common Knee Impairments Addressed by Manual Therapy
Impairment Manual Intervention Typical Delivery

Loss of knee Manual mobilization through range of Mobilization grades III and
extension motion (ROM) and knee extension at IV to III++ and IV++ 2–6
end range bouts of 30 s per manual
Knee extension technique
Knee extension with valgus or abduction Clinical observation: this
Knee extension with varus or adduction manual intervention may
provide near-immediate
decrease of symptoms and
may be approached with
relatively more vigor than
knee flexion
Loss of knee Manual mobilization through ROM and Mobilization grades of III-
flexion knee flexion at end range and IV- to III+ and IV+ 2–6
Knee flexion bouts of 30 s per manual
Knee flexion plus medial (internal) technique
rotation Clinical observation: pain with
end-range knee flexion may
be due to degenerative
meniscal tears; end-range
techniques should be
utilizedwith caution.
Loss of Manual mobilization of the patella in 5°– Mobilization grades of IV to

patellar glides 10° of knee flexion IV++ 2–6 bouts of 30 s per
Medial manual technique.
Lateral Clinical observation: some
Caudal patients may be intolerant of
Cephalad even slight compressive forces
over the patella; therapist
hand placement is Important.
Muscle Manual stretches at end length of the Sustained manual stretches of

tightness muscle 12–30 s duration repeated 1–
Quadriceps femoris 3 times per muscle.
161
Hamstrings Clinical observation: the
Gastrocnemius lumbar spine should be
Adductors manually stabilized and
Iliopsoas protected during all extremity
Tensor fasciae latae and the iliotibial stretches, particularly hip
band flexor stretches; many of
these patients also will have
arthritic changes in the spine,
and symptoms can be
increased without care in
positioning.
Soft tissue Soft tissue mobilization Circular fingertip and palm

tightness Suprapatellar and peripatellar regions pressure mobilization at the
Medial and lateral joint capsule depth of the capsule or
Popliteal fossa. retinaculum for 1–3 bouts of
30 s per area.
Clinical observation: the soft
tissue work in the popliteal
fossa seems to work best
when performed slowly with
occasional sustained positions
of 10–12 s, this technique
works well when combined
with the manual mobilizations
into knee extension.
5. Method of Delivery of Short Wave Diathermy

Position of patient: supine lying with a pillow below the knee joint.
Method used: capacitive method using pad electrodes.
Electrode placement: Contra planar across the medial-lateral aspect of the knee.
Intensity: the intensity should be adjusted to produce a sensation of mild warmth in the
patient. Patient is made to appreciate the warmth by asking him/ her to blow at the hand.
The degree of warmth felt at the knee should be same as that felt at the hand.
Duration: 20 minutes.
162
KNEE JOINT
INFORMED CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
this study.
in the “Comparative clinical evaluation of phanchkarma versus physiotherapy in patients of
sandhivata (osteoarthritis)-knee joint”.
Relationship ___________________________________
163
KNEE JOINT

Panchakarma is a textual classical and authentic treatment procedure of Ayurveda. Our
ancient sages and scholars like Charaka and Vagbhatta have attributed a lot of potential benefits
to Panchkarma practices. The aim of the study is to see the effect of Panchakarma in groupI
patients of Sandhivata (Osteoarthritis) and to compare the results with known physiotherapy
treatment in the patients of group II. This Physiotherapy treatment is usually referred to by doctors
of various Systems of Medicines.
Expected duration of the subject participation
An Ayurvedic physician along with a physiotherapist will take a brief history of the subject
and reveal him/her the facts about the benefits and side effects of the procedure. The volunteer
will be subjected to:
Local application of Pancaguna Taila 10-15 ml each joint, thrice a day, Nadi Sweda with
Dashmoola Kwatha for 15 minutes followed by rest for 15 minutes in group I.
The above mentioned Panchkarma treatment will be given for 4 weeks in the hospital
and then followed by 2 weeks Pancaguna Taila application at home.
In group II, Exercise Protocol for 4 weeks continuously in the hospital (consisting of
Manual Therapy, Stretching, Strengthening, and Range of Motion Exercises), followed by
exercises at home for another 2 weeks.
With above treatment, shortwave diathermy (a type of heat- therapy) for initial 2 weeks (6
days/ week) will be associated.
The benefits that might be expected from the out come of the research to the subject
The patients suffering from Sandhivata / OA, selected from CRIA will serve the cause of
science by participating in the study. We may be able to re-establish the facts and science of
Ayurveda already in use by our ancestors for last 2000 years. This treatment is expected to reduce
pain and swelling of the affected joints. The additional benefits that the subject may get that his/her
related investigations will be done free of cost .Apart from this the functional status of the patient
will improve.
164
Any risk to the subject associated with the study
Though the side effects are not very common, however in rare cases patient might develop
allergy with the oil. At times local irritation/ skin burn may happen during heat application.
Maintenance of the confidentiality of records
The records of the study will be kept confidential to protect volunteer’s privacy.
Compensation of subjects for disability or death resulting from injury
Not applicable
Freedom of individual to participate and to withdraw from research at anytime
without penalty or loss of benefits to which the subject would otherwise be entitled
Subjects will be free to withdraw from the study at any stage without assigning any reason,
without penalty or loss of benefits to which he/she would otherwise be entitled.
165
KNEE JOINT
CASE REPORT FORM – 1 SCREENING
Before Treatment
(Please tick wherever is applicable)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
2. Sex-Either sex
3. Patients with Primary Osteoarthritis – knee joints

(single or both knees)
4. Kellgren Lawrence (Radiological scale) of ≥ 2.
8. Age less than 40 years or more than 70 years.
9. Patients with skin allergies/skin diseases
10. Patients with Pott’s spine/infections/other systemic diseases.
166
11. Patients with systemic conditions such as Gouty
Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.
12. Patients with Diabetes/Hypertension
13. Bed ridden patients
14. Patients using local Anti-inflammatory medicine other

than the research drugs.
15. Patients taking active Allopathic/Homeopathic

treatment.
16. Low backache with or without radiation to legs.
17. Patients with metallic implants.
18. Subjects having any deformity of knee, hip or back.
19. History of bony or soft tissue injury to knee joint.
A patient is eligible for admission for treatment
If Sl. No. 1 – 4 is ‘Yes’ and Sl. No. 5 – 19 are ‘No’
If admitted, Sr. No. of the Subject: __________________
Date: ___________ Signature of the Investigator: ___________________
167
KNEE JOINT
CASE REPORT FORM – II HISTORY
Before Treatment
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
Constant sitting/standing for long hour (5)
11. Family income per months in Rs.
168
12. Total family members:
13. Marital status: Single (1) Married (2) Separated (3)
Widow (4) Widower (5)
History of present illness
14. Onset of disease Acute (1) Insidious (2)
15. Duration of disease (in months)
16. Factors aggravating the disease/chief complaints __________________________
17. Factors relieving main complaints ______________________________________
18. History of past illness, having relation with present illness : Yes (1) No (0)
If yes, Specify______________________________________________________
History of past illness:
19. History of trauma/ Injury Yes (1) No (0)
If yes, specify: ________________________________________________________
20. Undergone Treatment before Yes (1) No (0)
Family History:
21. Diet: Veg (1) Non-veg (2) Lacto-ova veg(3)
Fish-veg (4)
Sannipataj (7)
23. Manas Prakriti : Sattva (1) Rajas (2) Tamas (3)
Sattva-Rajas(4) Rajas-Tamas(5) Sattva-Tamas (6)
Sama (7)
169
Chief complaints with duration:
24. PAIN
Name of joints involved:
Duration
Increased by exertion Yes/ No Yes (1) No (0)
Relieved by taking rest Yes/ No Yes (1) No (0)
Pain at rest Yes/No Yes (1) No (0)
Radiating to other parts Yes/No Yes (1) No (0)
25. STIFFNESS
Duration
Morning stiffness Yes (1) No. (0)
Lasting for an hour or so Yes (1) No. (0)
26. SWELLING
Duration
27. RESTRICTED MOVEMENTS
Duration
Crepitus Yes/No Yes (1) No. (0)
Duration
28. VARIATION IN PAIN
Climate
Season
170
Day/night
Rest/movement
Walking/exertion
Other relations if any
GENERAL EXAMINATION OF THE PATIENT
29. G.C.: _____________________________
30. Pulse: _____________________________
31. B.P. : _____________________________
32. Respiratory Rate: _____________________________
33. Body weight: _____________________________
34. Pallor Present/Absent
35. Icterus Present/Absent
36. Oedema Present/Absent
37. Lymphadenopathy Present/Absent
38. Pigmentation Present/Absent
39. Deformity Present/Absent
SYSTEMIC EXAMINATION OF THE PATIENT
40. Gastro Intestinal System: _____________________________
41. Cardio Vascular System: _____________________________
42. Respiratory System: _____________________________
43. Central Nervous System: _____________________________
44. Genito Urinary System: _____________________________
45. Reticulo Endothelial System: _____________________________
171
Samprapti (pathogenesis) of the disease according to Ayurvedic concept:
46. Dosa Vata (1) Pitta (2) Kapha (3)
Anubandhya dosha
Anubandh dosha
Avaraka dosha
Ksheen dosha
47. Dushya (Involved) Rasa (1) Rakta (2) Mamsa (3)
Shukra (7) Ojas (8)
172
KNEE JOINT
CASE REPORT FORM – III LABORATORY INVESTIGATION
1. Centre: ………………..……….
3. Sr. No. of the subject: …………………………….........…………………………………
9. Date of Assessment :
INVESTIGATIONS PROFORMA
10. Blood Pathology
• TLC: _________________________
• DLC: _________________________
• ESR: _________________________
• Hb %: _________________________
11. Blood Bio-chemistry
• RA Factor: _________________________
• Serum calcium: _________________________
• Serum Alkaline phosphatase: _________________________
173
• Blood Urea: _________________________
• Serum Uric Acid: _________________________
• Blood-Sugar Fasting/PP: _____________/____________
• Others: _________________________
12. Radiology
• Soft Tissue swelling: _________________________
• Effusion: _________________________
• Osteoporosis: _________________________
• Erosion Cart/Bony: _________________________
• Deformity: _________________________
• Ankylosis: _________________________
• Reduced joint space: _________________________
DRUG TREATMENT GROUP-I/II
Medicine Dose & frequency Duration
SIDE EFFECTS/UNTOWARD EFFECTS IF ANY
174
ASSESSMENT OF TRIAL
Grade 0 = No Symptoms
Grade 1 = Mild Symptoms
Grade 2 = Symptoms Sufficient to Cause Distress/Difficulty in performing routine work
Grade 3 = Symptoms very severe/ patient unable to perform his routine work.
Symptoms Before Treatment After Treatment

(Severity Grades) (Severity Grades)
0 1 2 3 0 1 2 3
Pain
Tenderness
Swelling
Stiffness
Fatigue
Restricted Movement
Deformity
Before Treatment After Treatment
Walking Time
(Seconds)
Grip Power (mm/Hg)
Pressing Power
(mm/Hg)
ESR(mm/Hr)
Hb (Gm %)
175
WOMAC OSTEROARTHRITIS INDEX
SECTION A
PAIN
How much you have had …………………..
1. When walking on a flat surface?
Visual Analogue Scale
1 2 3 4 5 6 7 8 9 10
2. When going up or down stairs?
1 2 3 4 5 6 7 8 9 10
3. At night while in bed? (i.e. – pain that disturbs your sleep)
1 2 3 4 5 6 7 8 9 10
4. While sitting or lying down?
1 2 3 4 5 6 7 8 9 10
5. While standing?
1 2 3 4 5 6 7 8 9 10
176
SECTION B
STIFFNESS
6. How severe has your stiffness been after you first woke up in the morning?
1 2 3 4 5 6 7 8 9 10
7. How severe has your stiffness been after sitting or lying down or while resting leter in the
day?
1 2 3 4 5 6 7 8 9 10
177
SECTION C
PHYSICAL FUNCTION
8. When going down the stairs?
1 2 3 4 5 6 7 8 9 10
9. When going up the stairs?
1 2 3 4 5 6 7 8 9 10
10. When getting up from a sitting position?
1 2 3 4 5 6 7 8 9 10
11. While standing?
1 2 3 4 5 6 7 8 9 10
12. When bending to the floor?
1 2 3 4 5 6 7 8 9 10
178
13. When walking on a flat surface?
1 2 3 4 5 6 7 8 9 10
14. Getting in or out of a car, or getting on or of a bus?
1 2 3 4 5 6 7 8 9 10
15. While going shopping?
1 2 3 4 5 6 7 8 9 10
16. When putting on your socks or stockings?
1 2 3 4 5 6 7 8 9 10
17. When getting out of bed?
1 2 3 4 5 6 7 8 9 10
18. When talking off your socks or stockings?
1 2 3 4 5 6 7 8 9 10
179
APPENDIX

KNEE JOINT
KELLGREN– LAWRENCE RADIOGRAPHIC GRADING SCALE OF
OSTEOARTHRITIS OF TIBIO FEMORAL JOINT.
Grade of osteoarthritis Description
0 No radiographic findings of osteoarthritis.
1 Minute osteophytes of doubtful clinical significance.
2 Definite osteophytes with unimpaired joint space.
3 Definite osteophytes with moderate joint space narrowing.
4 Definite osteophytes with severe joint space narrowing and

subchondral sclerosis.
180
RECEIPT

KNEE JOINT
Received an amount of Rs 500/ (Five hundred only) from the institute as traveling expenses
for traveling to and fro the Institute for 4 weeks so as to participate in the above mentioned
research,
Signature or thumb impression: _____________________
Date: _________ Name of the Subject: ____________________________
Signature of the investigator with date: _______________________________
Signature of the Accounts Officer with date: ___________________________
181
Blank
182
CLINICAL VALIDATION OF GUGGULU, SHUNTI &
GUDUCHI IN RHEUMATOID ARTHRITIS
Drug: Study Code:

AND SIDDHA
183
Blank
184
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
I. BACKGROUND
Rheumatoid arthritis1 is a chronic multisystem disease characterized by persistent
inflammatory synovitis, usually, involving peripheral joints in a symmetric distribution. The potential
of synovial inflammation to cause cartilage destruction and bone erosions & subsequent changes in
joint integrity is the hallmark of the disease.
Exact etiology is unknown. Although recent work has focused on the possible role of
super antigens produced by a number of microorganism including staphylococci, streptococci and
mycoplasma arthritidis, other possible etiology mechanism in RA include a breakdown in normal self
tolerance leading to reactivity to self antigens in the joint such as type-II collagen or loss of
immuno regulatory control mechanism resulting in polyclonal ‘T’ cell activation. Superantigens are
protein with the capacity to bind to HLA-DR molecules and particular Vâ segments of the
heterodimetric T cell receptor and stimulate specific T cell expressive the Vâ gene products.
Of all the potential environmental triggers, the one only clearly associated with the
development of RA is cigarette smoking. Rheumatism arthritis effect females in three times more
than males it generally occurs in late third or fourth decade of their life spans.
The Ayurvedic treatment of Amavata - Rheumatoid arthritis is being increasingly recognized
as an alternate approach to its treatment. The modern treatment of this disease is not very
satisfactory and is often attended with serious reactions. As such efforts are being persistently
made for this dreadful disease. An important aspect of Ayurvedic treatment is its easy availability
and abundance of its ingredients.
According to Ayurveda some of etiological factors such as Viruddhahara (Improper &
irregular dietary habits), Viruddhachesta (Improper Physical and Psychological activities),
Mandagni, Sedentary habits and exercise immediately after food are said to be responsible for
the origin of Amavata.
References
1. Harrison’s Principle of Internal medicine: 15th Edition Page: 2083, Vol-II.
2. Madhav Nidana, Chapter 25,
185
Various studies on Amavata-Rheumatoid arthritis have been published in the JRAS and
other scientific journals. Some of the important publications dealing with development of diseases,
the Ayurvedic concepts of its etiopathogenesis, the dietetic management and effect of certain
therapies are presented in this compilation on Amavata.
The Agnimandhya-Grahani Dosa has been considered to be the main factor in pathogenesis
of this disease in Ayurveda. Certain studies have been conducted and reviewed to assess the
gastro-intestinal function. The findings indicate impaired secretion of gastric acid secretion, deranged
liver function and reduced intestinal absorption.
The cardinal features of Amavata are swelling and pain like scorpion bite over the joints
like hands and legs (especially knee, ankle wrist, metacarpals and metatarsals). Based on the
cardinal feature and other associated features, many effective regimens are described in Ayurvedic
classics.
Owing to the gravity of the situation, a need is felt for searching the safe /effective
Ayurvedic formulations to reduce the symptoms. Keeping all these view in consideration and the
public health needs, the council intends to initiate scientific studies on well known and safe classical
Ayurvedic formulation that is being successfully prescribed by Ayurvedic physicians without any
side effects since centuries.
For the present study, coded Ayurvedic drug like AYUSH-RA tab. and AYUSH-RA oil
have been taken to assess its clinical safety and efficacy.
II. OBJECTIVES
To study the effect of Guggulu, Shunti & Guduchi in rheumatoid arthritis
III. CENTRES
Sample Size : 50 cases in each center
Trial period : 18 months
Design of the study : Open observational Trial.
Drug & dosage : Tab. AYUSH-RA 2gm twice daily after food and
AYUSH - RA oil for external application 2 to 3
time daily.
Duration of the study : 45 days drug therapy with a follow up for 15
days without drug.
186
Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 15 days of
treatment.
• Age between 35 - 65 years of either sex
• Presence of any four of the following seven criteria (according 1987, revised criteria of
American College of Rheumatology)
(a) Morning stiffness: Stiffness in and around joints lasting one hour before maximal
improvement (More than 6 week’s duration).
(b) Arthritis of three or more joints (at lest three joint area, observed by Physician
simultaneously having pain with soft tissue swelling or joint effusion, not just bony
over growth) (More than 6 weeks duration).
(c) Arthritis of Hand joints (More than 6 weeks duration).
(d) Symmetric arthritis (More than 6 week’s duration).
(e) Presence of Rheumatoid Nodules
(f) Serum Rheumatoid factor- positive
(g) Typical Radiographic changes of arthritis on PA view of hand & wrist radiograph
that must include erosions or unequivocal bony decalcification adjacent to involve
joints.
2. Patients who develop secondary complication of RA e.g. Pleuro-pericardial disease,
severely damaged joint with bed ridden patients.
3. Any other serious illness e.g. Hepatic/ renal failure.
4. Patient with diagnosed other arthritis like Gouty arthritis, tuberculosis arthritis etc.
5. Patient receiving any other method of treatment.
The cases with following complications will be withdrawn from the study.
1. Aggravation of the disease during the course of the trial period.
2. Discontinuation of the treatment during trial.
187
3. Development of any serious complications requiring change in the treatment.
• The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA).
• Clinical assessment will be done and recorded on ‘0’ day, 15th day, 30th day, 45th day
and 60th day.
• Laboratory investigation will be done before and after treatment i.e. on ‘0’and 45th day.
IX. METHOD OF ASSESSMENT OF TREATMENT
The changes in the subjective and objective parameters before and after the treatment shall
be considered for assessment of the safety and efficacy the drug.
1. Clinical Assessment
Clinical assessment will be done (symptoms graded from 0 to 3) and recorded on the
zero day (i.e. one day before administering the trial drug), after completion of the treatment period
(i.e. on 45th day of the treatment) and on the final day of the follow-up (i.e. on 60th day).
Joint pain:
Sl. Severity of Pain Grade Score

1 No pain Zero 0
2 Pain occasional, can be managed I 2
without drug
3 Pain frequent and can be managed II 4
with some pain killer
4 Pain persistent and unmanageable III 6
even with drugs
Morning stiffness:
Sl. Morning stiffness Grade Score

1 No stiffness Zero 0
2 Early morning stiffness upto 30 minutes I 2
3 Early morning stiffness more than 30
minutes and less than 45 minutes II 4
4 Morning stiffness more than 45 minutes III 6
188
Tenderness:
Sl. Tenderness Grade Score

1 No tenderness Zero 0
2 Tender but bearable I 2
3 Tender and winced II 4
4 Tender winced and withdraw III 6
Swelling:
The circumference of swollen Proximal inter Phalangeal joints (PIPj) and big / major joints
are measured with simple measuring methods (soft & thin tape). (only a maximum of 3 PIPj & 3
major joints are to be measured indicating the names of the joints measured for the follow-up)
Swelling:
Sl. Severity of Swelling Grade Score

1 No swelling/not making the bony Zero 0
land marks of joints
2 Just covering the bony prominences I 2
3 Considerably above the land marks II 4
may be with positive fluctuation.
4 III 6
Sl. Name of the involved Measurement in mm.

joint Zero day 45th day 60th day
1
2
3
4
5
6
189
2. Functional assessments
Apart from this walking time in seconds, gripping power, pressing power using inflated mercury
manometer and writing time before treatment and once in every 15 days would be recorded till
the completion of the treatment.
a) Functional tests: To have an objective view of the improvements in the functions of the
affected joints, periodical functional tests have been done (Loxton, et al. 1952 and By-
waters et.al.,1950)
• Walking time: Patients were asked to walk a distance of 150 ft. and time taken has
been recorded.
Sl. Walking time in seconds

Zero day 45th day 60th day
1
2
3
4
5
Sl. Walking time in seconds Grade Score

1 Zero 0
2 I 2
3 II 4
4 III 6
5 IV 8
190
• Grip power: Patients were asked to squeeze the inflated cuff up to 50 mmHg of the
sphygmomanometer and the grip power has been recorded in m.ms. of mercury depending
upon the rise of mercury column.
Sl. Grip power (in mm Hg.)

1 Right hand Left hand
2 Zero day 45th day 60th day Zero day 45th day 60th day
3
4
Sl. Grip power Grade Score

1 If the scale shows between Zero 0
50-55 mmHg
2 between 56 - 65 mmHg I 2
3 between 66 - 75 mmHg II 4
4 between 76 - 85 mmHg III 6
5 86 mmHg & above IV 8
• Pressing power: Similarly when the patient presses the same inflated cuff up to 50 mmHg
against a table then it is recorded as pressing power.
Sl. Pressing power (in mm Hg.)

1 Right hand Left hand
2 Zero day 45th day 60th day Zero day 45th day 60th day
3
4
191
Sl. Grip power Grade Score
1 If the scale shows between Zero 0
50-55 mmHg
2 between 56 - 65 mmHg I 2
3 between 66 - 75 mmHg II 4
4 between 76 - 85 mmHg III 6
5 86 mmHg & above IV 8
ASSESSMENT ON BIO-CHEMICAL CHANGES

ESR and C-reactive proteins will be done before, monthly and after the treatment.
Sl. ESR (mm/1st hr) Grade Score

1 <20 Zero 0
2 21 to 40 I 2
3 41 to 60 II 4
4 61 to 80 III 6
5 >80 IV 8
ASSESSMENT OF SEROLOGICAL CHANGES

R.A. test (Latex fixation test) and Serum C-reactive protein will be done before monthly
and after treatment. The radiological changes will be assessed before and after treatment.
Sl. R.A. factor Grade Score

1 Negative Zero 0
2 Positive I 2
3 Strongly positive II 4
192
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
mail for analysis
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
study related adverse events
A consolidated amount of Rs. ………. /- per visit will be given i.e., on the 1st day of
recruitment after screening, 15th day, 30th day 45th day and 60th day.
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
193
CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical validation of guggulu, shunti & guduchi in rheumatoid arthritis.
Relationship ___________________________________
194

Arthritis is a vague and common terminology which literally means inflammation of the
joints. There are many types of arthritis which are generally grouped into three i.e. infective,
immunological and Degenerative. Arthritis is a global problem since the generation of mankind.
The incidence is on increase as a consequence of the fact developing science and technology,
which makes the man immobile even in midst of his comforts. The sedentary life style predisposes
more. India is no exception. Rheumatoid arthritis falls under immunological disorders. It s a
disabling disease and the disability is so great that suffers become physically crippled and becomes
invalid in family and society. It occurs in all climates, on all ethnic groups in the world in
developing countries it is estimated that 3% of the population is suffering. It affects the female
three times more than males. It generally occurs in late third or fourth decade of their life spans
and finally cripples the sufferers with deformities. Ayurvedic system also recognizes this clinical
entity as Amavata.
The coded drug AYUSH-RA tab. and AYUSH-RA oil are to be tried in Rheumatoid
arthritis.
instructions scrupulously. The study will take approximately 60 days. During this period, you are
expected to visit once in a 15 days during drug treatment and follow up period.
Before you start the treatment, clinical assessment and the Biochemical tests will be carried
out. If your diagnosis is confirmed and if you are a fit case you will be subjected to this study for
the period of 60 days. You will be supplied with the sufficient quantity of medicines to last until
your next visit i.e. once in every 15 days. The clinical assessment and the laboratory investigations
will be done before and after treatment for the therapeutic efficacy of the drug.
195
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
CASE REPORT FORM-I: SCREENING
1. Centre: ………………..……….
6. Postal Address ………………………….....………..………………………………………
1. Age between 35 - 65 years
2. Presence of any four of the following seven criteria

(according 1987, revised criteria of American
College of Rheumatology)
(a) Morning stiffness: Stiffness in and around joints

lasting one hour before maximal improvement
(More than 6 week’s duration).
(b) Arthritis of three or more joints (at lest three joint

area, observed by Physician simultaneously having
pain with soft tissue swelling or joint effusion, not
just bony over growth) (More than 6 weeks duration).
(c) Arthritis of Hand joints (More than 6 weeks duration).
(d) Symmetric arthritis (More than 6 weeks duration).
196
(e) Presence of Rheumatoid Nodules
(f) Serum Rheumatoid factor- positive
(g) Typical Radiographic changes of arthritis on PA

view of hand & wrist radiograph that must include
erosions or unequivocal bony decalcification adjacent
to involve joints.
4. Patients who develop secondary complication

of RA e.g. Pleuroperi cardial disease, severely
damage joint with bed ridden patients.
5. Any other serious illness e.g. Hepatic/ renal failure.
6. Patient with diagnosed other arthritis like Gouty arthritis,

tuberculosis arthritis etc.
7. Patient receiving any other method of treatment.
If Yes to Sl. No. 1 & 2 and No to Sl. No. 3 to 7 above, admit the subject to the trial.
If admitted, subject serial No. __________________
Date:____________ Signature of the Doctor _______________________
197
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
Total income of the family (in Rs.) ...........................................................
198
HISTORY OF PRESENT ILLNESS:
Chief complaints with duration (in days)
Yes (1) No (0) Duration

(in days)
10. Pain in Joints
If present, specify three major and three minor joints
11. Swelling in joints
12. Morning stiffness
13. Tenderness
14. Fever
FUNCTIONAL ASSESSMENT
15. Walking time (in seconds) __________________
16. Grip power in mm Hg:
Left hand Right hand
17. Pressing power in mm Hg
19. Previous episodes Yes (1) No (0)
20. Duration of disease (in days)
Personal History:
21. Diet: Veg (1) Non-veg (2) Lecto-veg (3)
199
Addiction
22. Smoking Yes (1) No (0)
If yes specify: (a) Quantity [packs] _____________________
(b) Total Duration in years ________________
23. Tobacco Yes (1) No (0)
If yes specify: (a) Quantity_______________________
(b) Total Duration in years____________
24. Alcohol Yes (1) No (0)
If yes specify: (a) Quantity (ml) _________
25. Any other (specify) ________________
26. Menstrual history: Regular (1) Irregular (2)
If irregular, Specify___________________________
27. Duration of menstruation: Up to 5days (1) 5-7 days (2)
More than 7 days(3)
28. Quantity Normal (1) Abnormal (2)
If abnormal, Specify__________________________________
29. Prakriti: Vata (1) Pitta (2) Kapha(3)
Vata-Kaphaj (4) Vata-Pittaja (5) Pittaja-Kaphaja(6)
Sannipataj (7)
30. Height: ___________________
31. Weight: ___________________
200
32. Pulse (per min) ____________
33. Blood Pressure (mm Hg) ___________
34. Body temperature (o F) _____________
35. Respiration rate (per min) _____________
36. Abnormal breathing sounds, specify____________
37. CVS
If abnormal, details_____________________________________________
38. CNS
41. Urogenital system
42. Vision
Date: ______________ Signature of Investigator: ______________________
201
(On 0th Day)
1. Centre: ………………..……….

(in days)
8. Pain in Joints
11. Tenderness
12. Fever
202
14. Grip power in mm Hg
Date: ______________ Signature of Investigator: _________________________
203

(On 15th Day)
1. Centre: ………………..……….

(in days)
7. Pain in Joints
8. If present, specify three major and three minor joints
12. Tenderness
13. Fever
204
205

(On 30th Day)
1. Centre: ………………..……….

(in days)
7. Pain in Joints
12. Tenderness
13. Fever
206
207

(On 45th Day)
1. Centre: ………………..……….

(in days)
7. Pain in Joints
12. Tenderness
13. Fever
208
209

(On 60th Day)
1. Centre: ………………..……….

(in days)
7. Pain in Joints
10. Tenderness
11. Fever
210
211
FORM IV – LABORATORY INVESTIGATIONS
(0th day)
1. Centre: ………………..……….
8. Stage of Assessment
Initial 4th week 8th week 12 th seek
9. Urine Examination:
Routine _____________ Microscopic____________
Ova/Cyst____________ Occult Blood____________
Blood Examination
11. TC (Cells/Cmm.): ______________________
12. DC P (%)______ L(%) ______ E(%)______M (%)_____B(%)______
13. Hb (g/dl) ____________________________
212
14. ESR (1st hour.)(mm) ____________________
15. Blood Sugar – PP (mg./dl): _______________
16. B.Urea (mg./dl): _____________________
17. S.Creatinine (mg./dl) _______________
18. Uric acid (mg./dl) ______________
19. C. Reactive protein _____________
20. RA factor (Latex fixation test)_____________
21. SGOT _________________
22. S.G.P.T _________________
23. S. Alkaline phosphatase ________________
24. Serum Bilirubin. ________________
25. X-ray chest PA view_________________
26. ECG 12 leads _________________
27. X-ray hand/foot/ limbs (before & after treatment) _________________
28. Any other Remarks _________________________________________________
213
FORM IV – LABORATORY INVESTIGATIONS
(60th day)
1. Centre: ………………..……….
8. Stage of Assessment
Initial 4th week 8th week 12 th seek
9. Urine Examination:
Routine _____________ Microscopic____________
Blood Examination
11. TC (Cells/Cmm.): ______________________
12. DC P (%)______ L(%) ______ E(%)______M (%)_____B(%)______
13. Hb (g/dl) ____________________________
214
14. ESR (1st hour.) (mm) ____________________
15. Blood Sugar – PP (mg./dl): _______________
16. B.Urea (mg./dl): _____________________
17. S.Creatinine (mg./dl) _______________
18. Uric acid (mg./dl) ______________
19. C. Reactive protein _____________
20. RA factor (Latex fixation test)_____________
21. SGOT _________________
22. S.G.P.T _________________
23. S. Alkaline phosphatase ________________
24. Serum Bilirubin. ________________
25. X-ray chest PA view_________________
26. ECG 12 leads _________________
27. X-ray hand/foot/ limbs (before & after treatment) _________________
Any other Remarks _________________________________________________
215
CASE RECORD FORM V
CONSOLIDATED DATA ON PERIODICAL OBSERVATIONS
1. Centre: ………………..……….
Sl Subjective/ 0 day/BT 15th day 30th day 45thday 60th day

Tobjective Dt. Dt. Dt. Dt. Dt.
Parameters
Yes No Yes No Yes No Yes No Yes No
(1) (0) (1) (0) (1) (0) (1) (0) (1) (0)
1. Pain in joints
2. Swelling in
joints
3. Morning
stiffness
4. Tenderness
5. Fever
6. Walking time
(in second)
7. Grip power
in mm Hg
216
8. Pressing power
in mm Hg
9. Other Associated Symptoms if Any [Specify]
10. Adverse reactions

11. Burning Not
sensation in applicable
abdomen
12. Nausea Not
applicable
13. Diarrhoea Not
applicable
14. Skin rashes Not
applicable
15. TC (Cells/Cu.
mm.)
16. DC (%) 13. P 13. P
14. L Not Not Not 14. L
15. E applicable applicable applicable 15. E
16. M 16. M
17. B 17. B
17. ESR (mm / Not Not Not
1st hour.) applicable applicable applicable
18 Hb (g/dl)
(Cyanomet
hamoglobin
method)
19. C. Reactive
protein
20 RA factor (Latex
fixation test)
22. S. Bilirubin
217
23. Total (mg/dl)
24. Direct (mg/dl)
25. SGPT (IU/L)
26. SGOT (IU/L)
27. S. Alkaline Not Not
phosphatase Applicable Applicable
(U/L)
28. S. Proteins
(Total) (g/dl)
29. Albumin (g/dl)
30. Globulin (g/dl)
32. Blood urea Not Not
(mg/dl) applicable applicable
33. S. Creatinine
(mg/dl)
Routine Not Not
Albumin (g/dl) applicable applicable
Globulin (g/dl)
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells
35. Stool Examination
Occult Blood Not Not
Ova/Cyst Not Not
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells
218
Continuing: (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
Date: ______________ Signature of the investigator ___________________
Name of the investigator ______________________
219
DRUG COMPLIANCE REPORT FORM – I
(To be filled by the trial participant)
(To be issued on 1st visit – 0 day and taken back on 2nd visit –15th day)
Registration No. of participant .....................................................................................................
Name of the participant ..................................................................................................................
Please come for next visit on ................................. (Date and time is to be filled by the Investigator)
Instructions to trial participant
• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.
• Please return the empty strip after taking medicine along with the compliance report duly
filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.
220
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Name of the participant .....................................................................
Date: ...........................................
Signature or Thumb impression of the participant ........................................
Signature of the Investigator with date ..........................................
221
DRUG COMPLIANCE REPORT FORM – II
(To be issued on 2nd visit – 16th day and taken back on 3rd visit –30th day)
filled.
medicine medicine
16.
17.
18.
19.
20.
222
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Date: ...........................................
223
DRUG COMPLIANCE REPORT FORM – III
(To be issued on 3rd visit – 31st day and taken back on 3rd visit –45th day)
filled.
medicine medicine
31.
32.
33.
34.
35.
224
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
Date: ...........................................
225
DRUG COMPLIANCE REPORT FORM – IV
(To be issued on 3rd visit – 46th day and taken back on 4th visit – 60th day)
filled.
medicine medicine
46.
47.
48.
49.
50.
226
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
Date: ...........................................
227
RECIEPT
Received an amount Rs ____________________ (Rupees_______________________ only)

from_________________________ (name) Institute/unit/center_________________ (station)
on _________________________________________________________________ (date) for
visit no.____________________________________
Date: _______________ Name of participant: ______________________

Sl. No. _________________
Signature or Thumb impression: _____________

Signature of the Investigator: _______________
Signature of Account’s Personnel /Office Personnel
Signature of the Director/In charge
228
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL
FOR THE TREATMENT OF OSETOPOROSIS
Drug: Study Code:

AND SIDDHA
229
Blank
230
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
TREATMENT OF OSETOPOROSIS
I. BACKGROUND
Pommer coined the term osteoporosis in 1885, which literally means increased porosity of
Bones.
It is described as a systemic skeletal disease characterized by low bone mass and micro
architectural detoriation of bone tissues with a consequent increase in bone fragility and susceptibility
to fracture. The magnitude of the problem has not been fully understood and the incidence of
osteoporosis is highly increased due to increased life span and greater awareness of the disease
since 1980 (Rosen et al, 1997). In recent study the following observations were made.
1) Osteoporosis1 occurs both in males and females in India.
2) Osteoporotic fractures occur more commonly in Indian males than females.
3) Osteoporotic fractures occur 10-20 years earlier in Indian men and women compared to
west (Wali, T.P. etal)
Certain factors like Genetic, personal life style factors like smoking, alcoholism lower
intake of calcium, non-exposure to sunlight and certain diseases predispose this disease.
In Ayurveda under the heading “Asthi kshaya” many signs and symptoms described can
closely be correlated with this clinical entity. This has also been treated with herbal and herbo
minerals since very remote past. In recent years the advancement in the field of Phytochemistry
and clinical trials, it has been evinced the role of certain herbals like Cissus quardrangularis in the
treatment of bone fracture. The phytochemical studies have also established the presence of
phytosterol, phytoestrogen and calcium. Embica officinalis is an anti-oxidant and thereby stabilizes
Vitamine-D metabolites or their conjugates present in the primary ingredient. Further it is
considered to promote collagen metabolism by virtue of its Vitamine-C like activity. Now
combination of Asthi Shrankhala( Cissus quardrangularis) and Amalki( Embica officinalis ) is
being taken up for study.
References
1. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
2. Bhaisajya Ratnavali, Chaukhamba Sanskrit Samsthan, Varanasi
231
In modern medicine this disease is managed with, Hormone replacement therapy and also
with calcium and Vitamin ‘D’ which is considered as anti resorptive and stimulator of Bone turn
over. But these drugs do have side effects like nausea, vomiting and diarrhea. In this contest the
natural calcium, which is safe, less toxic, and does not have any side effect will be taken for
study.
II. OBJECTIVES:
To assess the therapeutic efficacy of an Ayurvedic coded trial drug AYUSH B-caps in the
treatment of osteoporosis in comparison with standard control drug Calcium with Vitamin- D3.
III. CENTRES
Groups : Two – trial and control [50 (25 male and 25 female) cases
in each group (Control drug will be made similar to trial
drug and one placebo draggee will be prescribed after
dinner)
Group-I : Trial drug
Group-II : Control drug
Trial Design : Double blind randomized
Drug/Dosage/Duation:
Trial drug : Coded drug AYUSH B –Two caps 500 mg each twice a
day.
Control drug : Control drug 500 mg twice a day.
Duration of : One year
Treatment
Period of Study : One year for each case.
Total duration : will be Two years to complete the study.
1. Age: Patients of both sexes above 45 years and up to 70 years.
2. B.M.D. T. Score below – 1.5
232
The cases for carrying out BMD T Score will be screened with the following targeted
patients:
1. Post menopausal woman with early menopause (40 years and below) and familial
prevalence.
2. Patients with osteopenia or spinal deformities on spine-x-rays.
3. Patients on long-term cortico steroids for more than six months.
4. Patients with history of osteoporosis related fractures.
1. Age below 45 and above 70
2. T. Score below –1.5
3. Primary Hyper parathyroidsim
4. Thyrotoxicosis
5. Addison’s disease
6. Cushing syndrome
7. Rheumatoid arthritis
8. Malabsorption syndrome
9. Chronic liver diseases
10. Organ transplantation
11. Chronic renal failure
12. Prolonged immobilization
13. Diabetes (Uncontrolled)
14. Cases undergoing treatment for osteoporosis
15. Cases undergoing treatment for any other serious illness.
During the course of the trial there may be certain potential adverse threats like Kidney
stones, hypocalcaemia with renal insufficiency (milk alkali syndrome) and interference of calcium
with other essential nutrients. If any other side effects and other symptoms are observed then the
trial drugs will be withdrawn and will be treated symptomatically.
233
Clinical assessment will be done (O), at the end of 1st, 2nd and every subsequent month
till the completion of treatment (Form 2). The Lab investigations (Biochemical markers) will be
recorded before drug administration (O month) and after every two months till the completion of
trial (0, 2nd, 4th, 6th, 8th, 10th and 12th months i.e. the end of the treatment). The B.M.D. will be
done before and after the completion of the treatment.
IX. CRITERIA FOR ASSESMENT
30% or more in B.M.D. T. Score (above –1.5 level) increase will be considered as
significant improvement. .
Data on BMD T-Score will be analyzed using appropriate statistical tools. (Null
Hypothesis: There is no significant difference between the BMD T-score in the treated group and
control group).
CCRAS, HQ’s Office New Delhi will monitor the progress of the trial
XII. ETHICAL REVIEW
Clearance certificate from Institutional Ethical Committee (IEC) or Head of the Institution
should be obtained before the Project is initiated. IEC/Head of the Institution should submit
patient’s information sheet and informed consent form along with project proposal for approval.
Both of these forms should be maintained in duplicate with one copy given to the patient at the
The change between two BMD can be expressed in the form of (%) percentage between two measurements
or by absolute change in gm/cm between two measurements.
Percentage change is calculated as I BMD – II BMD x 100
I BMD
= (%) percentage change.
Absolute change is calculated as I BMD – II BMD
Absolute change
234
A consolidated amount of Rs. ___________ per visit.
personnel involved in the trial at CCRAS Hqrs. The investigators and technicians will be detailed
235
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the “Double blind clinical trial for the treatment of Osetoporosis”.
Relationship ___________________________________
236
DOUBLE BLIND CLINICAL TRIAL FOR THE TREATMENT OF
OSETOPOROSIS

Osteoporosis is characterized by increased fragility and susceptibility to fracture. It is a
disease very common and there is increase in its incidence due to increased life span and
advancement in health delivery system. Osteoporotic fractures occur 10-20 years earlier in Indian
men and women compared to west. The life style changes have also bearing on the predisposition
of this disease. In Ayurveda system also the management is done through herbal medicines and
this clinical entity can be correlated with Asthi Kshaya. The drugs which are used for the treatment
of Osteoporosis some time causes side effects. In Ayurveda the efficacy of herbal drugs like Asthi
Shrankhala and Amalki have been observed in clinical trials.and now these drugs are being takenup
for study with modern medicine calcitrol in 100 cases (50 each group)
instructions scrupulously. The study will take approximately one year to complete. During this
period, you are expected to visit the hospital thirteen times. The interval between the first and
second visit will be around one month. After it, you are required to visit once in a month till the
completion of the treatment.
physical examination, BMD Test (Bone Mineral Density). This is to make sure that you are eligible
for the study.
If you were found eligible, you would be put on trial treatment for one year. The daily
dosage will be 500mg twice. At each visit, you will be supplied with sufficient quantities of drugs
to last until your next visit. On completion of the treatment B.M.D. will be done again to asses the
effect of the treatment. Bio-chemical investigations will also be carried out one in every two
months.
237
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN
THE TREATMENT OF OSETOPOROSIS
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
1. Age between 45 and 70 years of either sex
2. Bone Mineral Density (B.M.D.)
CRITERIA OF EXCLUSION Yes (1) No (0)
3. Age below 45 and above 70
4. Primary hyper parathyroidsim
5. Thyrotoxicosis
6. Addison’s T. Score >-1.5 and <.4
7. Cushing syndrome
8. Rheumatoid Arthritis
9. Mal-absorption syndrome
10. Chronic liver diseases
238
11. Organ Transplantation
12. Chronic renal failure
13. Prolonged immobilization
14. Uncontrolled Diabetes
15. Cases undergoing treatment for osteoporosis
16. Cases undergoing treatment for any other serious illness
If ‘Yes’ to 1 and 2 & ‘No’ to 3 – 16 above, admit the subject to the trial. If admitted,
Subject serial No. ____
Date:____________ Signature of the Doctor ___________________
239
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
Addiction No (0) Yes (1)
10. Smoking
If yes specify: (a) Quantity (packs) _______________
(b) Total Duration in year’s _________
240
11. Tobacco
If yes specify: (a) Quantity ________________
(b) Total Duration in year’s _________
12. Alcohol
If yes specify: (a) Quantity (in ml/day) _________--_____
(b) Total Duration in year’s _________--_____
13. Prakriti: Vata (1) Pitta (2) Kapha (3)
Vata-Kaphaj(4) Vata-Pittaja(5) Pittaja-Kaphaja(6)
Sannipataj (7)
14. Height (cm) ____________
15. Weight (kg) ____________
MEDICAL HISTORY No (0) Yes (1)
16. Pathological Fracture(After the age of 40 yrs or more)
If yes indicate: Date_______ Site__________ History of pain before fracture_________
17. Family History of Osteoporosis
If yes indicate relationship_______________________________________
18. Spinal Deformity
If yes indicate site_________ Date from which suffering__________
Menstrual History (For female patients): No (0) Yes (1)
19. Age in years at Menarche
20. Duration of menstrual period in days
21. Interval of menstrual period
22. Age in years at onset of menopause
241
SURGICAL HISTORY No (0) Yes (1)
23. Abdominal Surgery
24. Hysterectomy
25. Oophorectomy
26. Orthopedic Surgery
Drugs used (having bearing on Osteoporosis) No (0) Yes (1)
27. Steroids
If yes indicate duration (in months) _______ Doses_______
28. Anti convulsive
If yes indicate duration (in months) _______ Doses________
29. HRT Heparin/Warfarin
If yes indicate duration (in months) _______ Doses________
Clinical Symptoms No (0) Yes (1)
30. Skeletal Pain
If yes indicate Region______________ Duration in months ________
31. Kyphosis
32. Other clinical symptoms
If yes, specify (Symptoms & Duration) ________________________________________
33. Type of pain Acute (1) Chronic (2)
Date:_______________ Signature of the Investigator_________________
242
1. Centre: ………………..……….
8. Month of Assessment :
Initial (0) 1st month (1) 2nd month (2)
3rd month (3) 4th month (4) 5th month (5)
6th month (6) 8th month (7) 9th month (8)
10th month (9) 11thmonth (10) 12th month (11)
Clinical Symptoms No (0) Yes (1)
9. Skeletal Pain
If yes indicate Region______________ Duration in months ________________
10. Kyphosis
11. Other clinical symptoms
If yes, specify (Symptoms & Duration) _______________________________________
12. Type of pain Acute (1) Chronic (2)
Date: ___________ Signature of the Investigator _______________________
243
TREATMENT OF OSTEOPOROSIS
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
Initial (0) 2nd month (1) 4th month (2)
6th month (3) 8th month (4) 10th month (5)
12th month (6)
9. Serum Calcium__________________________________(mEg / 100 cc)

BONE TURNOVER
10. Alkaline phosphate________________________________(King & Amstrong units)
(Bone specific)
11. Osteo calcin (BGP) ________________________________(King & Amstrong units)
12. Procollagen peptides________________________________
BONE RESORPTION
13. Pyridinium cross links and some of________________________________
Type – I Collagen Break down products in serum
14. Serum Tartarate resistant________________________________________
Acid phosphatase
Date: _____________ Signature of the Investigator: ______________
244
ANORECTAL DISORSERS
SECTION - IV
245
Blank
246
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE
MANAGEMENT OF FISSURE-IN-ANO (PARIKARTIKA)
Drug: Study Code:

AND SIDDHA
247
Blank
248
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA1)
I. BACKGROUND
An Anal Fissure is a tear in the skin around the opening of the Anus1. It can cause sharp
pain, especially when opening the bowels. Anal Fissure is thought to be a common disorder for
which many people do not seek medical advice. The internal anal sphincter is thought to play a
key role in the development of an Anal Fissure. This is one of two muscles that control the
opening of the anus. Both muscles need to relax in order to pass a stool. Unlike the exterior anal
sphincter, which can be tensed or relaxed voluntarily, there is no voluntary control of the internal
sphincter. Because of the pain of a fissure, the internal anal sphincter may go into spasm - causing
a raised pressure within the anus. This excess pressure makes it harder to pass a stool, making
constipation worse, and contributing to a vicious circle. The spasm of the internal anal sphincter
can also restrict the blood supply to the anal skin, which reduces its ability to heal.
The condition Parikartika has been mentioned in the Ayurvedic literature as one of the
fifteen kinds of disorders which may result from an injudicious use of purgatives owing to the
ignorance of the physician or of the patient. Improperly done virechana karma (purgatives)
aggravates the Vata & Pitta that gives rise to a sort of cutting, sawing pain in the anus, penis,
umbilical region and the neck of the bladder (Vasti). The omission of flatus is arrested the Vayu
lies incarcerated in the abdomen and relish for food vanishes.
Application of Creams or Ointments that contain local anaesthetics (eg lidocaine) or
steroids (eg hydrocortisone) and an injection of outline toxin (Botox), anal dilatation,
sphincterotomy, and fissurectomy (chronic fissure) are usually in practice. But these procedures
have sometimes associated with some complications like post operative anal stenosis, sphincter
incontinence etc. To overcome such problems and to provide cheap, simple, ambulatory and
effective treatment, different treatment modalities have been kept on trial on the basis of the
treatment mentioned in the ancient literature and also based on the preliminary work done in the
management. Earlier workers have tried Kaseesadi Taila Vasti, Jatyadi Ghtrita per rectal
application, hot sitz bath and a laxative, taking lead from the ancient classics especially descriptions
described about the use of Picchavasti and Anuvasana Vasti in the treatment of parikartika.
Though different regimens have proved to be efficacious in the treatment of fissure-in-ano, patients
References
1. Charak Siddhi sthana 6/29
249
feel difficulty in pushing of Kaseesadi Taila in to the anal canal. Sometimes there was an
immediate spillage of oil after pushing due to spasm of the sphincter. More over it was found
difficult to assess which procedure was more effective in the combined therapy of pushing of oil
and application of ghee manually per rectally. In order to see the efficacy of various procedures
individually, it was thought to try different therapeutic regimens in present study beside the
development of a novel method of dilatation of anal canal to see the effect of different procedures
/ drugs in the management of fissure-in-ano.
II. OBJECTIVES
• To provide symptomatic relief in shorter duration
• To provide healing to the fissure-in-ano
• To find out a simple, amble, safe & cost effective therapeutic regimen or procedure in the
management of fissure-in-ano
III. CENTRES
CCRAS identified Centers.
Trial Drug /Dosage :
Group: I
• Triphala churna; 5gm with warm water daily at bedtime for 28 days
• A novel method of Anal dilatation for 07 days
• Hot Sitz bath for 28 days Anal dilatation:
A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.
The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:
Day 1 : 5ml
250
Day 2 : 7ml
Day 3 : 10ml
Day 4 : 15ml
Day 5 : 20ml
Day 6 : 20ml
Day 7 : 20ml
Group: II
• Triphala churna; 5gm with warm water daily at bed time for 28 days
• Anal dilatation with Jatyadi Ghrita for 07 days
• Hot Sitz bath for 28 days
Anal dilatation:
Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal Canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal Canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.
Group: III
• Triphala Churna; 5gm with warm water daily at bed time for 28 days
• Application of Jatyadi Ghrita (P/R) (without dilatation) for 07 days
Application of Jatyadi Ghrita (P/R)
The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal Canal without applying much pressure in the Canal.
The same procedure is to be carried out for seven days.
251
Duration of the trial : Total six weeks: (28 days as per the schedule
given under each group and last two weeks
follow-up without any medication.
Design of the Study : Open trial
Selection of cases : Any age of either sex with complains of Pain with or without
bleeding per rectum during and/or after the defecation with or without other symptoms like, itching,
discharge, constipation, with /or without pain are examined and confirmed by peri-anal
examination are admitted for the study.
The cases are randomly selected irrespective of age, sex, chronicity, Prakriti and type of
fissure.
The cases associated with malignancy were excluded from the study.
VII CRITERIA FOR WITHDRAWAL
events which requires urgent treatment or if patients themselves want to withdraw from the study,
such subjects may be withdrawn from the trial.
recorded as per case record form I & II. Clinical and physiological assessment in form III and
laboratory investigations in forms IV will be done regularly.
IX. CRITERIA OF ASSESSMENT
Since the pain is the main symptom in Fissure-in-ano, a total number of days taken to
heal the ulcer with alleviation of pain and associated symptoms are noted and results are assessed
in the following manner.
Sl. Response Response Description

Duration
1 Complete < 7 days When there is complete relief in pain during/after
Response defecation without any bleeding within 7 days of the
therapy started. No recurrence thereafter up to 6 weeks
of the follow-up.
252
2 Partial 08 – 14 When there is complete relief in pain during/after
Response days defecation without bleeding after 7 days but before 14
days of the therapy and no recurrence thereafter up to 6
weeks of the follow-up.
3 Poor 15 – 21 Complete relief in pain after 14 days but before 21 days
Response days of the treatment without bleeding and recurrence
thereafter up to 6 weeks of the follow-up.
4 No 22 days & When there is any relief in pain or partial relief or relief
Response above in pain after 22 days of the therapy and/or recurrence
thereafter.
5 Drop-out Drop-out Discontinuation of the treatment during the trial due to
development of any complications & aggravation of the
disease.
Data on intensity of pain, duration of pain will be tabulated and analysed by using
appropriate statistical methods.
However the data of each case will have to be communicated on completion of trial
therapy to the Statistical Officer of CCRAS through e-mail.
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS.
approval by IEC. Both will be maintained in duplicate with one copy given to the patient at the
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB)
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
253
study related adverse events
A consolidated amount of Rs.______ /- per visit i.e., on the 1st day of recruitment after
screening, 3rd week, & 6th week (3 times)
research Institutes should be conducted at identified reputed Tabs /Government Institutes under
intimation to this Council observing requisite codal formalities.
254
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
this study.

in the clinical trial on “Multi centric open Clinical trial on the management of Fissure-in-
ano (Parikartika).”
Relationship ___________________________________
255
FISSURE-IN-ANO (PARIKARTIKA)
What is the study about? What is an Anal Fissure?

An anal fissure is a small tear in the lining of the Anal Canal. This type of tear may
develop in adults from passing hard or large stools during bowel movements. Anal Fissure is also
common in infants between 6 and 24 months. Anal Fissures are less likely to develop in older
children.
An Anal Fissure may cause you to experience pain and bleeding. More than 90 percent
heal without surgery, and you can use topical creams or suppositories to provide relief as they
heal. Anal fissures that fail to heal may become chronic and cause considerable discomfort. Certain
Ayurvedic formulations and procedures were proved to be effective in the management of fissure-
in-ano.
What are signs and symptoms of an anal fissure?
The main signs and symptoms of an anal fissure include:
• Pain or burning during bowel movements that eases until the next bowel movement
• Bright red blood on the outside of the stool or on toilet paper or wipes after a
bowel movement
• Itching or irritation around the anus
• A visible crack in the skin around the anus
When to see a doctor?
See your doctor if you have pain during bowel movements or blood on stools or toilet
paper after a bowel movement.
instructions scrupulously. The study will take approximately six weeks. During treatment period,
you are expected to visit the hospital daily from day one to seven days then on 14th, 21st, 28th,
35th & 42nd day.
256
If you are found eligible, you would be put on trial treatment for six weeks.
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc., noticed
during the treatment period, this should be noticed to the doctor who is treating you.
257
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
CASE REPORT FORM-I: SCREENING
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
1 Pain or burning sensation during or after defaecation
2 Bleeding per rectum during or after defaecation
3 Associated with Itching or irritation around the anus
4 A visible crack in the skin around the anus (Fissure-in-ano)
5 Bright red blood on the outside of the stool or on the toilet paper
6 Constipated bowels
CRITERIA OF EXCLUSION:
7 History of malignancy
If Sl. No. 1 – 6 is ‘Yes’ and Sl. No. 7 are ‘No’
If recruited, subject serial No: ______________
Date: __________________ Signature of the investigator: _______________________
258
1. Centre: ………………..……….
8. Address ……………………………………..……………..........…………………………
9. Educational status: Illiterate 1 Read and Write 2 Primary School 3
Middle School 4 High School 5 College 6
Other (specify) 7 I.N.A. 8
10. Occupation: Desk work 1 Field work 2
Field work with physical labour 3
Field work with intellectual 4
11. Family income per month in Rs. Rs. Income per capita in Rs.
12. Religion: Hindu 1 Muslim 2 Sikh 3
Christian 4 Parsi 5
13. Dietary Pattern: Vegetarian Non-Vegetarian
259
14. Likes: __________________________________________________________________
15. Habits: Smoking Drinking Chewing Pan
Tobacco
HISTORY Yes (1) No (0) Duration

(in days)
16. Chronic illness:
17. Allergy:
18. Surgery:
19. Communicable diseases
FAMILY HISTORY
20. Type of family: Nuclear No. of persons:
Joint: No. of persons:
Yes (1) No (0)
21. Diseases: Chronic illness:
Hypertension:
Diabetes:
Genetic disorders:
If yes, specify: __________________________________________________
Psychiatric disorder:
Other:
22. History of recent delivery (in case of female): ___________________________________
HISTORY OF PRESENT COMPLAINTS Yes (1) No (0)
23. Pain or burning sensation during or after defaecation
24. Bleeding per rectum during or after defaecation
260
25. Associated with Itching or irritation around the Anus
26. A visible crack in the skin around the Anus (Fissure-in-ano)
27. Bright red blood on the outside of the stool or on

the toilet paper
28. Constipated bowels
29. Medication: Yes (1) No (0)
a. Whether received any treatment previously
b. Any surgical interventions made for any disease
CLINICAL EXAMINATION Yes (1) No (0)
General Examination
30. Blood Pressure: TPR:
31. Height
32. Weight
33. Chest : Auscultation: Heart: Lungs:
34. Abdomen:
35. Extremities - Inspection: Clubbing of fingers
Pedal Oedema: Varicose veins:
Local / Peri-anal Examination:
1. Condition of skin around anus:

12 0
2. Condition of the fissure :
Acute Chronic
Presence of Sentinel pile : Yes / No

90 30
Position of the fissure o clock position:
60
No. of fissures :
261
3. Digital examination
Tenderness Present / Absent
Sphincter tone:
Hyper tonic /Normal /Hypo tonic
Any mass palpated in the canal
4. Anoscope/Proctoscopic examination (not in Acute cases)
Treatment:
Group: I
• Triphala churna: 5gm with warm water daily at bed time for 28 days
• A novel method of Anal dilatation for 07 days
• Hot Sitz bath for 28 days Anal dilatation:
A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the Anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the Anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.
The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:
Day 1 : 5ml
Day 2 : 7ml
Day 3 : 10ml
Day 4 : 15ml
Day 5 : 20ml
Day 6 : 20ml
262
Day 7 : 20ml
Group: II
• Anal dilatation with Jatyadi Ghrita for 07 days
Anal dilatation:
Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.
Group: III
• Application of Jatyadi Ghrita (P/R) (without dilatation) for 07 days
Application of Jatyadi Ghrita (P/R)
The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal canal without applying much pressure in the canal.
The same procedure is to be carried out for seven days.
Remarks:
Signature of the Investigator
263
(From day one to seventh day and subsequently on 14th, 21st, 28th, 35th &
42nd day)
1. Centre: ………………..……….
7. Day of Assessment: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, 28th, 35th & 42nd day
CLINICAL ASSESSMENT CHART: (Mention ‘Y’ for Yes, ‘N’ for No)
FOLLOW UP
Symptoms & Signs: Initial First month Second month Third month
Abdominal pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda
264
- Bheda
- Sula
Low back pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda
- Bheda
- Sula
Pain in lower limbs
Nausea / Vomiting
Constipation
Giddiness
Tenderness on palpation
Breast tenderness
Diarrhea
Headache
Fainting
Drug Compliance Chart: 100% 75-99% 50-74% <50%

1.
2.
3.
Complications if any:
Outcome of Trial:
Completed:
Drop out: Reason: ____________________________
Died: Cause______________________________
Date: Signature of the Investigator
265
MLTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE - IN ANO (PARIKARTIKA)
CASE REPORT FORM IV - A - LABORATORY INVESTIGATIONS
(On Day 1)
1. Centre: ………………..……….
5. Address ................................................................................................................................
Routine: _______________________ Microscopic: ___________________
Routine: _______________________ Microscopic: ___________________
Occult Blood: __________________ Ova/Cyst: ___________________
Blood Examination
9. TLC (Cells/Cmm.): _______________
10. DLC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
11. ESR (mm / 1st hour.) __________
12. Hb (g/dl) (Cyanmethaemoglobin method) ____________________
13. General Blood Picture for morphology of RBC ______________________
Normocytic Normochromic /Microcytic Hypochromic /Macrocytic Normo/hypochromic
266
14. S. Bilirubin (mg/dl)
15. SGPT (IU/L)
16. SGOT (IU/L)
17. S. Alkaline phosphatase (KA unit)
18. S. proteins (gm/dl)
20. S. Creatinine (mg/dl)
Date: _____________ Signature of investigator _______________________________
267
(On Day 35)
CASE RECORD FORM IV-PERIODICAL OBSERVATION AND ASSESSMENT
FORM IV-B – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
7. Address: ...............................................................................................................................
9. Hb (g/dl) (Cyanomethaemoglobin method) ____________________
Normocytic Normochromic /Microcytic Hypochromic /Macrocytic Normo/hypochromic
Date: _____________ Signature of investigator _______________________
268
CASE RECORD FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
1. Centre: ………………..……….
7. Address: ...............................................................................................................................
Sl Subjective/ objective 0 day/BT 15th day 30th day 45thday/AT

1. M.C.V. (Fl)
2. Serum iron (ìg/dl)
3. Serum ferritin (ìg/dl)
4. Hb (g/dl) (Cyanomet
haemoglobin method)
5. PCV (%)
6. General Blood Picture
for morphology of
RBC
Normocytic
Normochromic
269
Microcytic Hypochromic
Macrocytic Normo/
hypochromic
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
Blood urea (mg/dl)
S.Creatinine(mg/dl)
Improved No change Deteriorated
Status of the patient:
Continuing
Drop out Reason: _____________________________
Died Cause: _______________________________
Date: ______________ Signature of investigator _________________________
270
COMPARATIVE CLINICAL EVALUATION OF SELECT
AYURVEDIC TREATMENT MODALITIES IN THE
MANAGEMENT OF ARSHA
Drug: Study Code:

AND SIDDHA
271
Blank
272
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
I. BACKGROUND
Concept of Arsha as described in Ayurveda is quite wider. ‘Arsha’ includes a variety of
conditions pertaining to Ano-rectal and other parts/organs of the body. Present study includes
conditions pertaining to Ano-rectal Arsha. Only Sushruta has described four fold methods of
treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.
Medical/conservative treatment includes various Ayurvedic medicines which decrease intra-
abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other
Oils/like Kashishadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used
medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi
churna etc. Locally Kashishadi tila and inflammatory conditions Jatyadi taila are prescribed.
In certain other cases Ksarakarma and Ksharasutra are used effectively. Plain thread
ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids
on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shastrakarma are some other
methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine)
treatment is the most suitable treatment in the Arsha of:
• Rectal origin
• History of mild/moderate bleeding
• Small, negligible or invisible haemorrhoidal mass
• Associated with diarrhoea/dysentery
References
1. Baily and Love – Short practice of surgery, 24th Edition, 2004, Arnold Publication, London
2. Charaka Samhita, Chikitsa Sthana, Arsha Chikitsa, Chapter–15, Vidyotini Hindi Vyakhya by Pt.
Kashinath, Choukhamba Orientalia, Varanasi
4. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary) Nidana Arshonidana
2nd Chapter, Chi. 6th Chapter, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
273
It is safe and easily available method to prescribe medicines and patient’s acceptability is
good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.
Piles (haemorrhoids – internal haemorrhoids arise in the upper Anal Canal and lower rectum form
the internal various haemorrhoidal plexus. They enlarge to involve the skin-lined lower Anal Canal
and the external haemorrhoidal venous plexus to become visible externally.
Bright red bleeding is common as is prolapse of the piles on defecation, discomfort,
mucuous discharge and partial incontinence. The patient is investigated by proctoscopy and tehn
by sigmoidoscopy to ensure that no other lesion is responsible for the bleeding. Symptomatic piles
are treated on an out patient basis by injection of sclerosant or by rubber band ligation.
Haemorroide ctomy is reserved for more severe cases.
II. OBJECTIVE
Bhesaja, Ksarakarma, Raktavasecana, Agnikarma and Sastrakarma are the measure
adopted to treat Arsha Roga (Haemorrhoids) as described in Ayurvedic texts. The present study
is aimed at reducing the effect of some Ayurvedic medicines oral and local upon Gudarsh (Piles)
in various groups for comparison. The therapy so planned is non-invasive and may give relief to
a patient while keeping him active (at O.P.D. levels).
III. CENTRES:
Identified centres of CCRAS,New Delhi .
IV. SAMPLE SIZE AND METHODS:
Sample Size : 90 patients (30 patients in each group)
Trial Drug/Dosage/Duration
Group I : Kankayan Vati : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Kaseesadi Taila : 2 ml locally before defecation
Group II : Kravyadi Rasa : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Group III : Kankayan Vati : 500 mg thrice a day
Kravyadi Rasa : 500 mg thrice a day along with
Abhayarishta : 15 ml thrice a day
274
Diet
Normal diet
Design of the study – Single blind open trial.
Duration of the Study - 21 days drug therapy with a follow up for every 15 days upto 3
months
1) Age > 5 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Bleeds/does not bleed
6) Ano-rectal Arsha only/pertaining to Ano-rectal
7) Pile mass palpated/seen by P/R exam or proctoscopy
VI. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool
3) Corrhosis liver-portal hypertension
4) Tuberculosis/Diabetes/Systemic disease
5) Bleeding diathesis
6) Multiple haemorrhoids/externo-internal haemorrhoids
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any side effect of the drug
recorded as per case report form I & II. Clinical and physiological assessment in form III and
275
laboratory investigations i.e. Urine Routine & Microscopic, Stool Routine & Microscopic, TLC,
DLC, ESR, Hb%, B.T., C.T., P.T., Blood Sugar Fasting &PP, Proctoscopy, Sigmoidoscopy will
be done.
Assessment will be done as per proforma after three months of regular treatment. However
the patients are to be reviewed after every 15 days.
Good Response
Complete disappearance of known symptomatology in absence of any other complication
with considerable regression in the size of pile mass.
Fair response
50% and above relief in presenting symptomatology of the disease with no/negligible
change in the size of pile mass.
X. TRIAL MONITORING AND STATISTICAL DATA ANALYSIS
Progress of the study can be mentioned by the clinicians by P/R exam or proctoscopy.
Improvement in symptoms can also be assessed and the data analyzed statistically.
XI. ETHICAL REVIEW:
Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by IEC.
A consolidated amount of Rs.…… /- per visit.
Short-term training will be provided to the Investigators and Laboratory personnel
involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and technicians
will be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
intimation to this Council following Codal formalities.
276
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Comparative Clinical Evaluation of select Ayurvedic Treatment
Modalities in the Management of Arsha”.
Relationship ___________________________________
277

Concept of Arsha as described in Ayurveda is quite wider. ‘Arsha’ includes a variety of
conditions pertaining to Ano-rectal and other parts/organs of the body. Present study includes
conditions pertaining to Ano-rectal Arsha. Only Sushruta has described four fold methods of
treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.
Medical/conservative treatment includes various Ayurvedic medicines which decrease intra-
abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other
oils/like Kashishadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used
medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi
churna etc. Locally Kashishadi tila and inflammatory conditions Jatyadi taila are prescribed.
In certain other cases Ksharakarma and Ksharasutra are used effectively. Plain thread
ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids
on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shgstrakarma are some other
methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine)
treatment is the most suitable treatment in the Arsha of:
• Rectal origin
• History of mild/moderate bleeding
• Small, negligible or invisible haemorrhoidal mass
• Associated with diarrhoea/dysentery
It is safe and easily available method to prescribe medicines and patient’s acceptability is
good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.
Piles (haemorrhoids – internal haemorrhoids arise in the upper Anal Canal and lower rectum form
the internal various haemorrhoidal plexus. They enlarge to involve the skin-lined lower anal canal
and the external haemorrhoidal venous plexus to become visible externally.
Bright red bleeding is common as is prolapse of the piles on defecation, discomfort,
mucuous discharge and partial incontinence. The patient is investigated by proctoscopy and tehn
by sigmoidoscopy to ensure that no other lesion is responsible for the bleeding. Symptomatic piles
are treated on an out patient basis by injection of sclerosant or by rubber band ligation.
Haemorroide ctomy is reserved for more severe cases.
278
you are expected to visit the hospital six times i.e. on 15th, 30th, 45th, 60th, 75th and 90th day for
clinical and physiological assessment.
also be done.
279
1. Name of the patient ....................................................... Age .................. Sex ...................
. Address: ..............................................................................................................................
..............................................................................................................................
2. Centre
4. Group No. First Second
Third Fourth
CRITERIA FOR INCLUSION YES NO
5. Age > 5 years
6. Ano-Rectal Arsha (Haemorrhoids)
7. Arsha seen on P/R proctoscopy
8. Bleed/does not bleed
9. Painful/Painless
10. Fresh/Previously operated
CRITERIA FOR EXCLUSION YES NO
11. Patient with malignancy
12. Incontinence of stool
13. Cirrhosis liver-portal hypertension
14. Tuberculosis/Diabetes/Systemic disease
15. Bleeding diathesis
280
16. Multiple haemorrhoids/externo internal haemorrhoids
17. Cardiac disease/neurological disease
If Sl. No. 5 to 10 is ‘Yes’ and Sl. No. 11 to 17 are ‘No’
Date: _______________ Signature of the Investigator: ____________________
281
2. Address: ..............................................................................................................................
3. Date of Admission Date of Discharge
4. Centre
Third Fourth
7. Educational status: Illiterate Read and write Primary
Middle school High school College
Others (specify) INA
8. Occupation Desk work Field work
Field work with physical labour
Field work with intellectual
Indicate nature of work…………………………….................................
9. Total income of the family (in Rupees)
10. Total family members
11. Income per capita per month (in Rupees)
12. Religion Hindu Mulsim Christian
Parsi Others
282
13. Marital status Married Unmarried Divorcee/
separated
Chief complaints with duration (in months)
Present Absent Duration
14. Pain
15. Swelling
16. Tenderness
17. Itching
18. Indurations
19. Bleeding Mild Moderate
Before defecation With defecation
After defecation
20. Type of pain Pricking Cutting Throbbing
Burning Itching Mixed
21. Onset of disease Operated Non-operated
22. Duration of disease
23. Location of pile mass O’clock position
24. Size of pile mass
25. Sentinel tag/Thrombotic pile
FAMILY HISTORY, IF ANY YES NO
26. Hypertension
28. Piles
283
29. Tuberculosis
30. Others
If yes specify………….......………………………….…………………………………….
PERSONAL HISTORY Yes No
31. Smoking
32. Obesity
33. Non-vegetarian
34. Alcoholic
35. Spices intake
36. Emotional stress
37. Bowel habit
38. Sharirik Prakriti
Vataja Pittaja Kaphaja
Vata Kaphaja Vata Pittaj Pitta Kaphaj
Sannipataj
39. Manas Prakriti
Sattva Rajas Tamas
Sattva-Rajas Sattva-Tamas Raja-Tamas
Sama
40. Built Lean Medium Heavy
284
44. Pulse
45. Respiration
46. Pulse rate
47. Oedema C.V.S.
GASTRO INTESTINAL TRACT Present Absent
48. Hepatomegaly
49. Sleenomegaly
50. Tumour/Lump
51. Portal hypertension
SAMPRAPTI (PATHO GENESIS) OF THE DISEASE ACCORDING AYURVEDIC

CONCEPT
52. Dosh Vata Pitta Kapha
53. Dushya Rasa Rakta Mamsa
Meda Asthi Majja
Shukra
54. State of disease (Roga kriya kala)
Sanchaya Prakopa Prasar
Sthanasamshraya Vyakti Bheda
Date: _______________ Signature of the Investigator: _________________________
285
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 15 days, 30 days, 45 days, 60 days, 70 days and 90 days)
1. Code No. (of clinical trial)_____________________

2. Centre________________________________
3. Sl. no. of the subject ____________________
4. Name __________________________________________Age________ Sex_________
5. Date of Assessment _________________________
Chief complaints with duration (in days) Present Absent Duration
6. Pain
7. Swelling
8. Tenderness
9. Itching
10. Indurations
11. Bleeding Mild Moderate
Before defecation With defecation
After defecation
12. Type of pain Pricking Cutting Throbbing
Burning Itching Mixed
If yes, specify_________________________
Date: _______________ Signature of the Investigator: ___________________
286
CASE REPORT FORM IV- LABORATORY ASSESSMENT
1. Code No. (of clinical trial)_____________________
2. Centre________________________________
3. Sl. no. of the subject ____________________
4. Name __________________________________________Age________ Sex_________
5. Date of Assessment _________________________
Routine Microscopic
Routine Microscopic
Occult Blood Ova/Cyst
Blood
8. TLC (Cells/Cu. mm.) _______________
9. DLC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
10. ESR (mm / 1st hour.) __________
11. Hb (g/dl) (Cyanomethamoglobin method) ____________________
12. S. Bilirubin
• Total (mg/dl)
• Direct (mg/dl)
287
13. SGPT (IU/L)
14. SGOT (IU/L)
15. S. Alkaline phosphatase (U/L)
16. S. Proteins (Total) (g/dl)
• Albumin (g/dl)
• Globulin (g/dl)
18. S.Creatinine (mg/dl)
19. Blood Sugar
• Fasting
• Post prondial
20. S. Cholesterol
Special Tests
(i) Proctoscopy
(ii) Sigmoidoscopy
Date: _____________ Signature of investigator _________________________
288
CASE REPORT FORM I – SCREENING OF THE CASES
1. Name of the patient…………………………....…….. Age …………….. Sex ……...........
2. Centre
4. Group No.
INITIAL During Treatment
15 Days 30 Days 45 days 60 days 70 days 90 days
CLINICAL PARAMETERS
Pain
Swelling
Tenderness
Itching
Indurations
Bleeding
LAB INVESTIGATIONS
Stool for occult blood
Note: Severity of the symptoms may be graded as I, II and III grades as per positively in
increasing order (mild 1, moderate 2 and severe 3)
* To be done at the beginning and at the end of the study.
289
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290
COMPARATIVE CLINICAL EVALUATION OF
KSHARASUTRA VIS-À-VIS APPLICATION OF KSHARA
VATI IN THE MANAGEMENT OF BHAGANDARA
(FISTULA-IN-ANO)
Drug: Study Code:

AND SIDDHA
291
Blank
292
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
I. BACKGROUND
Bhagandara1 (Fistula in ano), Arsha (haemorrhoids) and Gudavidara (Parikartika) are some
ano rectal torturesome diseases. Among these, Bhagandara is one of the most painful diseases. It
is a disease of ano rectum which is characterized in humans by single or multiple sinuses with
purulent discharge. It is an obnoxious condition.
This is a field where modern surgery could not help much as extensive excision of the
fistulous tract result into a wide open wound with slow healing rate. Chances of wound infection,
non-healing and recurrences are high. Application of Ksharasutra in the management of fistula-in-
ano showed encouraging results (Deshpande et al 1989). The patients can abstain from
psychological trauma and extensive surgery.
Patients can undergo treatment without paralyzing their routine work.
Kshara Vati is also found to help in such cases. Thus it is important to evaluate the result
after a comparative study.
II. AIMS AND OBJECTIVE
Medical management of diseases in Ayurveda is quite popular. However, there are diseases
which can be treated by para-surgical methods in better way. Management of Bhagandara by
Ksharasutra is one such example. Thus the present study is proposed with a view to:
1. Study the disease pattern of Bhagandara (Fistula in ano)
2. To evaluate the effect of Ksharasutra application in the management of Bhagandara
(Fistula in ano)
3. To compare it with the effect of Kshara Vati (applied 7 times in 21 days) in the
management of Bhagandara (Fistula in ano)
References
1. Sushruta Nindan 4th cheptar.
293
III. SAMPLE SIZE AND METHODS
Sample Size : 60 cases
No of Groups : 2 (30 patients in each group) (Patients to be randomly
allocated to different treatment groups)
Type of Study : Single blind
Level of Study : O.P.D.
Period of Study : 21 days in Kshara Vati
In Ksharasutra group according to disease
Dose Schedule
(i) Ksharasutra application depends upon the severity and depth of fistula.
(ii) Kshara Vati will be applied seven times at the interval of every two days.
Note: Renewal of Ksharasutra will be decided by the research workers looking
after the problem.
Diet
Normal diet
IV. CRITERIA OF INCLUSION
1) Age preferably above 8 to 10 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Discharging/non-discharging
6) Purulent/non-purulent
7) Tender/non-tender
8) All cases of fistula in ano
V. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool/stricture of anus
3) Tuberculosis/Diabetes/Systemic disease/infections
294
4) Bleeding diathesis
5) Fistula connected with other organs like urethra vagina etc.
VI. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after 21 days of regular treatment in group
treated with Kshara Vati. However in case of Ksharasutra application it depends upon the disease
and physicians perception.
VII. CRITERIA FOR ASSESSMENT OF RESULTS
1. Good Response:
Complete disappearance of known symptomatology
• absence of any other complication
• Normal healing of the wound
2. Fair response:
50% and above relief in presenting symptomatology of the disease
• Absence of complications
• Healing of the wound more than 75%
3. Poor response:
25% to 50% relief in symptomatology + some improvement in the wound
4. No response
No relief in symptomatology or otherwise
VIII. CRITERIA FOR WITHDRAWAL
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any toxicity/local reaction of Sutra/Vati
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
mail for analysis
295
X. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XI. ETHICAL REVIEW:
Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with
project proposal for approval by EC. Both will be maintained in duplicate with one copy
given to the patient at the time of entry to the trial.
A consolidated amount of Rs.……. /- per visit i.e., on the 1st day of recruitment after
screening and at the end of 7th, 14th, 21st and 30th day of months. (5 times)
personnel involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and
technicians will be detailed about the clinical trial conduct and laboratory procedures in order to
maintain the uniformity.
Microscopic
Urine
Routine
Microscopic
Stool Cyst
Routine
Ova
Stool: - For Occult Blood
Sputum: - A.F.B. (To exclude Koch’s if required)
296
Fasting
Blood Sugar
PP
Blood: - TLC, DLC, ESR, Hb%, B.T., C.T., P.T.

X-rays: - Barium enema (as required)
- Fistulo-graphy
Special test: - Proctoscopy
- Sigmoidoscopy
297
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Comparative clinical evaluation of ksharasutra vis-à-vis application
of kshara vati in the management of bhagandara (fistula-in-ano)”.

Relationship ___________________________________
298

Bhagandara (Fistula in ano), Arsha (haemorrhoids) and Gudavidara (Parikartika) are some
ano rectal torturesome diseases. Among these, Bhagandara is one of the most painful diseases. It
is a disease of ano rectum which is characterized in humans by single or multiple sinuses with
purulent discharge. It is an obnoxious condition.
This is a field where modern surgery could not help much as extensive excision of the
fistulous tract result into a wide open wound with slow healing rate. Chances of wound infection,
non-healing and recurrences are high. Application of Ksharasutra in the management of fistula-in-
ano showed encouraging results (Deshpande et al 1989). The patients can abstain from
psychological trauma and extensive surgery.
you are expected to visit the hospital three times i.e. on 0, 8th, 15th and 22nd day for clinical and
physiological assessment.
also be done.
299
2. Address: ..............................................................................................................................
3. Centre
Third Fourth
CRITERIA FOR SELECTION YES NO
1. Age above 8 – 10 years
2. Either sex
3. Fresh/Previously operated
4. Painful/Painless
5. Discharging/Non-discharging
6. Purulent/Non-purulent
7. Tender/Non-tender
8. All cases of fistula in ano
CRITERIA FOR EXCLUSION YES NO
9. Patient with malignancy
10. Incontinence of stool/stricture of anus
11. Tuberculosis/Diabetes/Systemic disease/Infections
12. Bleeding diathesis
300
13. Fistula connected with other organs like Urethra vagina etc.
Date: _______________ Signature of the investigator: ___________________
301
BHAGANDARA (FISTULA IN ANO)
2. Address: ..............................................................................................................................
3. Date of Admission Date Discharge
4. Centre
Third Fourth
Total iincome of the family (in Rupees)
Total family members
9. Income per capita per month (in Rupees)
10. Religion Hindu Mulsim Christian
Parsi Others
302
11. Marital status Married Unmarried Divorcee/
separated
12. Pain
13. Burning
14. Swelling
15. Tenderness
16. Itching
17. Indurations
18. Onset of disease Acute Insidious
19. Duration of disease (in months)
20. Factors aggravating the disease/chief complaints………….....……………………………...
......…………………………………………………………………………………………
21. Factors relieving main complaints…………………………………………………………...
..……………………………………………………………………………………………
22. History of past illness, having relation with present illness
Yes No
If yes, specify…………………………………………………………………………
Treatment given so far: Modern Ayurvedic Any other
VARIOUS SURGERY DONE YES NO
23. Open + Drainage
24. Drainage + Saucerization
303
25. Excision
26. Saucerization + Wiring
27. Excision + Grafting
No. of times surgery done: Once Twice more than twice
Date of last surgery
FAMILY HISTORY IF ANY YES NO
28. Hypertension
30. Ano Rectal disease
31. Tuberculosis
32. Others
If yes specify…………………………….......……….…………………………………….
32. Sharirik Prakriti
Vataja Pittaja Kaphaja
Vata-Kaphaja Vata-Pittaj Pitta-Kaphaj
Sannipataj
33. Manas Prakriti
Sattva Rajas Tamas
Sattva Rajas Sattva Tamas Rajas Tamas
Sama
35. Gait Normal Abnormal
304
39. Pulse
40. Respiration
Present Absent
41. Anaemia
42. Jaundice
43. Lymphadenopathy
Normal Abnormal
44. C.V.S. (With Chest)
45. C.N.S
305
SAMPRAPTI (PATHO GENESIS) OF THE DISEASE ACCORDING AYURVEDIC
CONCEPT
49. Dosha Vata Pitta Kapha
50. Dushya Rasa Rakta Mamsa
Meda Asthi Majja
Shukra
51. State of disease (Roga kriya kala)
Sthanasamshraya Vyakti Bheda
LOCAL EXAMINATION
52. Inspection
1). Condition of skin near fistula YES NO
Normal
Inflamed
Indurated
External piles/tags
Discolouration of skin
2). Opening
No. Position (Clockwise) Distance from anal verge in Cm.
3). Digital Examination
Fissure Yes No
Thrombotic piles Yes No
Sphincteric tone Normal
Hypertonic
306
Hypotonic
Prostate Normal Enlarged
4). Type of discharge
(i) Blood (ii) Pus (iii) Faecal material (iv) Urine (v) Gas
5). Probing
Location of Fistula Towards
Depth of Fistula Cms.
Character of Fistula
(i) Blind ext. (ii) Blind int.
(iii) Complete (iv) Bilateral
(v) Radial (vi) Curved
(vii) Horse shoe (viii) Straight
6). Proctoscopy YES NO
1. Presence of pile
2. Inflammation
3. Location of int. opening
7). Sigmoidoscopy
1. Done 2. Not done
If done then………………………………………………………………………….
Yes No
A. Ulceration
B. Bleeding
C. Mucous
307
8). Biopsy
1. Done 2. Not done
CLASSIFICATION OF FISTULA
53. Modern view
1. Low cutaneous
2. Sub. Mucous
3. Low anal
4. High anal
5. Ano rectal
6. Pelvi rectal
54. Ayurvedic view
1. Shataponak (Vataja)
2. Ushragreeva (Pittaja)
3. Parisravi (Kaphaja)
4. Shambukartava (Sannipataja)
5. Unmargi (Agantuja)
Provisional Diagnosis
Final Diagnosis
Principal Drug Therapy
Date: ………………….. Signature of the Investigator: ………………………..
308
1. Centre………………………………………………………………………………………
3. Patient No.
4. Group No.
INITIAL Days after starting therapy
7th day 14th day 21st day 30th day
5. Pus-discharge
6. Induration
7. Inflammation
8. Pain
9. Burning sensation/itching
10. Bleeding
ASSESSMENT OF UNIT CUTTING TIME OF FISTULOUS TRACT
UNIT CUTTING TIME TOTAL NO. OF DAYS

INITIAL LENGTH IN CMS.
(OF FISTULA)
Date: ………………………... Signature of the Investigator: ………………
309
CASE REPORT FORM IV– INVESTIGATION
1. Centre………………………………………………………………………………………
3. Patient No.
4. Group No.
Investigation Time of after 7 days after 14 days after 21days after month
Admission
Microscopic
5. Urine
Routine
6. Urine Glucose
Microscopic
7. Stool Cyst
Routine
Ova
8. Stool: for Occult blood

9. Haematology: TLC
DLC
ESR……………(1 Hr.)…………..mm. (2 Hr.)…………..mm.
310
10. Biochemistry
Fasting
11. Blood Sugar
PP
Bariumenema (if required)

Fistulogram
Proctoscopy
Sigmoidoscopy (if required)
Date: ………………………... Signature of the Investigator: ………………………..
311
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312
NERVOUS SYSTEM
SECTION - V
Blank
314
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
TREATMENT IN THE MANAGEMENT OF
PAKSHAGHATA
Treatment modalities : Study Code:

AND SIDDHA
315
Blank
316
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA
I. BACKGROUND
Paksaghata (hemiplegia) is a major disabling disease of mankind. The terms Paksaghata,
Parsavadha and Ekangaroga are synonyms of the same disease and are used in classical
treatises in various contexts. Caraka has classified it as Nanatmaja vata vyadhi caused due to
vitiation of Vata dosa and considered it as a Maharoga from the point of prognosis – difficult to
cure. According to the concept, the disease affects the Madhyama roga marga and disrupting the
functions of Sira, Snayu, Kandara etc. According to modern terminology, hemiplegia is the
sequelae of pathological events which take place in the central nervous system, may be due to
different factors such as cerebro-vascular accidents neoplasm, infections etc. where in paralysis
will be common symptom. Ayurveda has a definite pattern of treatment for such conditions. The
line of treatment includes Snehana, Svedana and Panchakarma therapy. The Snehana and
Svedana therapy mentioned in the classics are used as preparatory mearues for Sodhana therapy.
(Caraka Samhita Chikitsa 28-100, Susrut Chikitsa 5-19). This Council has taken up this
problem for research and different methods of therapy used in clinical practice are taken up for
intensive evaluation of their efficacy of samana therapy alongwith Panchakarma therapy. A series
of clinical studies to evaluate the effect of herbo-mineral preparation and application of Sastikasali
pindasveda with Brihat Masa Taila alongwith Panchakarma therapy has shown that these
therapies are giving significant results and found effective in relieving hypertenic (stiffness) of
muscles and to improve the functional ability of the affected limb (P.K.N. Namboodiri et al,
2000, Management of Hemiplegia by Panchakarma & Samana therapy CCRAS). The objective
of present study is to evaluate the effect of samana &panchakarma therapies with and without
internal medication in the management of Paksaghata1.
II. OBJECTIVES
To assess the efficacy of Ayurvedic treatment in the management of Pakshaghata.
References
1. Charak Chikitsa 28 Ch. (Vata Vyadhi Chikitsa)
317
III. CENTRE
CCRAS identified Centers.
Sample Size : 100 patients (50 in each in group, two groups)
Treatment
A. Sodhan Chikitsa
1. Snehapana - Murchita tila taila (maximum 7 days)
2. Svedana - Vaspa Sveda (3 days)
3. Virecana - Eranda Taila (1 day)
4. Samsarjana - 7 days
5. Abhyanga - Brihat masa Taila (7 days)
6. Yogabasti (8 days) (a) Anuvasana – Morchitataila (240ml) [1st, 3rd, 5th,
7th, 8th] (Oil Enema –Dose 240ml)
(b) Asthapana – [2nd, 4th, 6th]
(Decoction Enema – Dose 960ml)
Erandamula Kvatha (480 ml.)
Morchitataila (240ml)
Honey – 180 ml
Satahva – 24 gm
Saindhava – 12 gm
** One Day Rest
7. Nasya Kshirabala taila - 3 times (Potency) (7 days)
** One Day Rest
B. Samana therapy
Internal _ Ekangavirarasa (250 mg twice daily)/ Placebo (250 mg.) BD.
Externally – 1. Morchitataila (50ml) (Abhayanga)
2. Sastikasali pinda Sveda – 14 days
318
Design of Study: Randomized double blind placebo controlled study.
1. All the patients will be provided with the Sodhana therapy for 35 days.
2. After completion of Sodhana therapy patients will be devided into two groups. One group
will receive trial drug in the dose of 250 mg. twice daily for 30 days along with
Abhyanga for 30 days and Sastikasasli pinda sveda for 14 days. The other group will
receive placebo in the dose of 250 mg. twice daily for 30 days along with Abhyanga for
30 days and Sastikasasli pinda sveda – for 14 days. Oral drug as well as Abhyanga
and Sastikasasli pinda sveda will run simultaneously.
Period of Study: Six months of each case. Total duration will be two and half years to complete
the study.
Follow Up: One follow up will be carried out at the end of 6th month.
1. Age: More than 20 years and less than 70 years.
2. Duration of illness more than 6 months but less one year.
3. Patients of stable one time stroke with hemiparesis or hemiplegia with or without facial
paralysis.
4. Patients with non-progressive neurological disease causing Para paresis (plegia) such as
- Compressive mydopathy (operated)
- Non-compressive (post-viral, denyclinating, post traumatic, vascular)
5. Motor deficit should be 3/5 or less (MRC Grade).
6. Spasticity of a scale of 3 or more (Ashwarth Scale)
7. Medically stable
8. Fully conscious and oriented
9. Normal Higher mental functions
1. Age less 20 and more than 70 years.
2. Progressive Neurological diseases.
3. Pregnancy & lactation.
4. Insulin dependent diabetis mellitus (IDDM)
319
5. Impaired sensorium
6. Recurrent strokes.
7. History of Renal and liver diseases
8. Cases undergoing treatment for any other serious illness.
A patient may be withdrawn from the study on account of the following.
1. Recurrent attacks of strokes.
2. Development of any major ailments, side effects necessitating institution of new modalities
of treatment.
3. Worsening of symptoms.
4. Patient failure to report for follow-up or irregular medication.
the proforma (Forms I & II). Clinical assessment will be done before the therapy, at the end of
5th week, end of 9th week, end of 6th month (Form III). The lab investigations will be recorded
before therapy, end of 5th week, end of 9th week and at the end of follow up (6th month)
(Form IV).
IX. CLINICAL ASSESSMENT:
MOTOR PARALYSIS
a). Clinical muscle strength testing – MRC Grading:
0. - Nil
1. - Flicker of movement.
2. - Movement with gravity eliminated.
3. - Movement against gravity.
4. - Movement against minimal resistance
5. - Movement against maximum resistance.
b). ADL (Activities of Daily Living) Score
c). Dynamometers – for measuring isometric strength.
320
Spasticity:
A. Clinical
a. -Ashworth Scale Score:
0. - No increase in tone
1. - Slight increase producing a catch when a joint is moved in flexion or extension.
2. - More marked increase in tone, but joint easily flexed
3. - Considerable increase and passive movements difficult.
4. - Affected part rigid in flexion or extension.
b. -Spasm Score:
0. - No spasms
1. - Mild spasms induced by stimulus
2. - Spasms occurring less than 1 per hour
3. - Spasms occurring more than 1 per hour
4. - Spasms occurring more than 10 per hour
c. - Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
B. Biomechanical Techniques:
Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the
muscles across a joint.
- Wartenberg’s pendulum or the “drop” test.
- With an electrogoniometer to record the changes in the knee joint angle.
- Relaxation index.
321
methods.
The progress of the trail will be monitored by field visits by Monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELLING EXPENSES
A consolidated amount of Rs……../- per visit will be paid to the subject.
The Laboratory Investigations (Pathological / Biochemical, Radiological / Sonography etc.)
which are not available at research Institutes will be referred to any reputed/Government Institutes
under intimation to this Council following codal formalities.
322
MANAGEMENT OF PAKSHAGHAT
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the, “Double blind clinical trial of Ayurvedic treatment in the management of pakshaghat”.
Relationship ___________________________________
323
MANAGEMENT OF PAKSHAGHAT

Pakshaghata (hemiplegia) is a major disabling disease of mankind. The terms Pakshaghata,
Parsavadha and Ekangaroga are synonyms of the same disease and are used in classical treatises
in various contexts. Caraka has classified it as Nanatmaja vyadhi caused due to vitiation of Vata
dosa and considered it as a Maharoga from the point of prognosis – difficult to cure. According
to the concept, the disease affects the Madhyama roga marga and disrupting the functions of Sira,
Snayu, Kandara etc.
According to modern terminology, hemiplegia is the sequelae of pathological events which
take place in the central nervous system, may be due to different factors such as cerebro-vascular
accidents neoplasm, infections etc. where in paralysis will be common symptom. Ayurveda has a
definite pattern of treatment for such conditions. The line of treatment includes Snehana, Svedana
and Panchakarma therapy. The Snehana and Svedana therapy mentioned in the classics are used
as preparatory mearues for Sodhana therapy. (Caraka Samhita Chikitsa 28-100, Susrut Chikitsa
5-19). This Council has taken up this problem for research and different methods of therapy used
in clinical practice are taken up for intensive evaluation of their efficacy of samana therapy
alongwith Panchakarma therapy. A series of clinical studies to evaluate the effect of herbo-mineral
preparation and application of Sastikasali pindasveda with Brhat Masa Taila alongwith
Panchakarma therapy has shown that these therapies are giving significant results and found
effective in relieving hypertenic (stiffness) of muscles and to improve the functional ability of the
affected limb (P.K.N. Namboodiri et al, 2000, Management of Hemiplegia by Panchakarma &
Samana therapy Snamaa and Panchakarma, CCRAS). The objective of present study is to
evaluate the effect of samana & panchakarma therapies with and without internal medication in the
management of Paksaghata.
However, considering the eco- climatic changes traces of certain unwanted substances may
lead to untoward effects. Thus this project is undertaken to assess the clinical safety in subjects
receiving Ayurvedic preparations.
period, you are expected to visit the hospital 3 times (0, 15 and 30 days) for clinical, biochemical
and physiological assessment.
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also be done. If you are found eligible, you would be put on treatment for 1 month.
Date: ______________ Principle Investigator:____________________________________
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MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
BEFORE TREATMENT
1. Centre: ………………..……….
6. Address ……………………………………..…………..........……………………………
CRITERIA OF INCLUSION Yes (1) No (0)
1. Age: More than 20 years and less than 70 years
2. Duration of illness more than 6 months, but less one year
3. Patients of stable one time stroke with Hemiparesis or

hemiplegia with or With out Facial Paralysis.
4. Patients with Non Progressive Neurological diseases
5. Motor deficit –3/5 or less[MRC Grade]
6. Spacticity of a scale of 3 or more (Ashworth scale)
7. Medically Stable, fully conscious & oriented
8. Normal Higher Mental Functions
9. Age less than 20 years and more than 70 years
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10. Progressive Neurological diseases
11. Pregnancy & lactation
12. IDDM
13. Impaired Sensorium
14. Recurrent strokes
15. History of Renal & Liver Diseases
Dated:____________ Signature of the Doctor _________________________
327
CASE REPORT FORM II – HISTORY PROFORMA
1. Centre : ........................................
3. Sr. No. of the Subject : _______________________
5. Address: ..............................................................................................................................
9. Family income per month in Rs.
10. Total Family members :

(in months)
11. Paralysis/Weakness of upper limb
12. Paralysis/Weakness of lower limb
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13. Difficulty for locomotion
14. Rigidity
15. Flacidity
16. Spasm
17. Numbness
18. Head ache
19. Difficulty in speech
20. Pain in either half of the body
21. Incontinence/retention of urine
22. Incontinence/retention of Motion
23. Facial Palsy
24. 26. Other complaints, if any (Specify) ______________________________
25. History of serious illness in the past (if any):___________________________
Personal History
26. Diet: Veg 1 Non-veg 2
27. Bowel habits Regular 1 Irregular 2
Addiction
28. Smoking No 1 Yes 2
If yes specify: (a) Quantity (packs per day) _______________
(b) Total Duration in year’s ______________
29. Tobacco No 1 Yes 2
If yes specify: (a) Quantity per day_________
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30. Alcohol No 1 Yes 2
If yes specify: (a) Quantity per week (ml)_________
31. Any other(specify)________________
Family History No (0) Yes (1)

32. Hemiplegia
33. Hypertention
34. Cardio vascular disease
35. Other, specify____________________________________________________
36. Prakriti: Vata 1 Pitta 2 Kapha 3
Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6
Sannipataja 7
37. Physical Examination
38. Built Lean 1 Medium 2 Heavy 3
39. Gait Normal 1 Abnormal 2
40. Height (cm) ________________________
41. Weight (kg) ________________________
42. Pulse (per min) ________________________
43. Blood Pressure Systolic(mm Hg) ___________
44. Blood Pressure Diastolic (mm Hg) ___________
45. Respiration rate( per min) ______________
46. Body Temperature ______________
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47. CNS
If abnormal details_____________________________________________
49. CVS
Dated: ________________ Signature of the Investigator_________________
331
(0th, 5th, 9th Weeks and 6th Month)
1. Centre : ........................................
5. Address: ..............................................................................................................................
6. Date of Birth Age (in years)
8. Stage of Assessment: Initial 0 3rd Week 1
11th Week 2 6th Month 3
Clinical Symptoms Absent(0) Present(1)
9. Paralysis/Weakness of upper limb
10. Paralysis/Weakness of lower limb
11. Improvement in locomotion 0____________________________________10
12. Numbness(VAS) 0____________________________________10
13. Improvement in speech 0____________________________________10
14. Incontinence / retention of urine 0____________________________________10
15. Incontinence / retention of Motion 0____________________________________10
16. Facial Palsy 0____________________________________10
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OBJECTIVE PARAMETERS
MOTOR PARALYSIS
17. Clinical muscle strength testing – MRC Grading:
0. - Nil
1. - Flicker of movement.
2. - Movement with gravity eliminated.
3. - Movement against gravity.
4. - Movement against minimal resistance
5. - Movement against maximum resistance.
18. ADL (Activities of Daily Living) Score
19. Dynamometers – for measuring isometric strength.
20. Spasticity
CLINICAL PARAMETERS
21. Ashworth Scale Score:
0 - No increase in tone
1 - Slight increase producing a catch when a joint is moved in flexion or extension.
2 - More marked increase in tone, but joint easily flexed
3 - Considerable increase and passive movements difficult.
4 - Affected part rigid in flexion or extension.
22. Spasm Score:
0 - No spasms
1 - Mild spasms induced by stimulus
2 - Spasms occurring less than 1 per hour
3 - Spasms occurring more than 1 per hour
4 - Spasms occurring more than 10 per hour
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23. Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
BIOMECHANICAL TECHNIQUES
(Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the muscles
across a joint.)
24. Wartenberg’s pendulum or the “drop” test
25. With an electrogoniometer to record the changes in the knee joint angle.
26. Relaxation index.
27. Overall clinical assessment by the investigator:
Improved 1 No change 2 Deteriorated 3
Deteriorated 4
Continuing 1
Drop out 2 Reason: _____________________________
Died 3 Cause: _______________________________
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(0th, 5th, 9th week and 6th month)
1. Centre : ........................................
5. Address: ..............................................................................................................................
8. Stage of Assessment: Initial 0 3rd Week 1
11th Week 2 6th Month 3
Urine Examination
A. Routine:
9. pH _______
10. Specific gravity_________
11. Sugar
12. Albumin
13. Bile Salt
14. Bile pigment
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B. Microscopic ______________________________
Blood Examination
15. Hb (g/dl) _______________
16. ESR (1st hour)(mm) _______________
17. TC (Cells/Cmm.) _______________
18. DC: P(%)_____ L(%) _____ E(%)_____ M (%)_____ B(%)_____
19. PCV (%) _______________
20. Blood Sugar – PP(mg./dl)_______________
21. Cholesterol (mg./dl) _______________
22. HDL (mg./dl) _______________
23. LDL (mg./dl) _______________
24. S. Triglycerides (mg./dl) _______________
25. B. Urea (mg./dl) _______________
27. Uric acid (mg./dl) _______________
28. Total proteins (gm./dl) _______________
29. Albumin(gm./dl) _______________
30. Globulin(gm./dl) _______________
31. A/G Ratio _______________
32. SGOT _______________
33. SGPT _______________
34. Total Bilirubin _______________
336
Serum Electrolytes
35. Na+ ______________________
36. K+ _______________________
37. Cl- ______________________
38. X-ray Chest: [0 Month only] ___________________________________
39. ECG [0 Month & 6 month] ____________________________________
40. CT Scan [0 Month only] ____________________________________
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338
ASSESSMENT OF THERAPEUTIC EFFICACY OF
AYUSH-M NASAL DROPS AND AYUSH-M CAPSULE IN
THE MANAGEMENT OF MIGRAINE WITH OUT
AURA (ARDHAVA BHEDAKA)
Drug : Study Code:

AND SIDDHA
339
Blank
340
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BHEDAKA)
I. BACKGROUND
Migraine1 (Ardhava Bhedaka) is as old as civilization, occupying 16% among clinical
classification of headaches, has become a challenging problem to the present day physician1&2. It
is a paroxysmal disorder characterized in its fully developed form by visual and/or sensory
phenomena in an aura associated with or followed by unilateral headache and vomiting. While this
definition is satisfactory of ‘Classical’ Migraine, there are many patients who never experience an
aura and in whom the headache is always bilateral; the single most characteristic and constant
feature is that migraine is a paroxysmal disorder, i.e., the headaches occur in attacks, separated by
intervals of freedom. It is described as a separate clinical entity in the classics of Caraka and
Susruta while Vagbhata included this condition in the classification of Vatajashiroroga. A clinical
study conducted on 20 cases migraine to evaluate the effect of Nasya Karma with fresh leaf juice
extracted from Acalypha indica Linn. (Haritamanjari,) along with internal medication of
Panchagavya ghrta (Astanga Hradya, Uttara Tantra 7/18) revealed significant clinical
improvement.
II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-M coded nasal drops and Ayush-M capsule
in the management of Migraine without aura.
References
1. Peter J Goadsby et al, Diagnosis and management of migraine, Selections from BMJ Vol.12 July,
1996 pp 456-460.
2. Classification Committee of the International Headache Society. Classification and diagnostic
criteria for headache disorders, cranial neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-
96.
3. Srikanth N. et al, Clinical study on the role of Nasyakarma and Ghritapana in the management
of Arddhavabhedaka vis-à-vis Migranous headaches, Aryavaidyan Vol.XIX, No.3, Fe-Apr.2001
: 166-171.
341
III. CENTRE
Central Research Institute (Ay.), New Delhi
Design of the study – Open trial
Treatment
a. Snehana: Local application of Til oil around nose followed by local mridu swedana(mild
fomentation) as poorva karma
b. Ayush-M Nasal drops {containing equal parts of Acalypha indica Linn. (Haritamanjari,)
and Glycyrrhiza glabra (Yasti madhu) – 3-drops in each nostril after poorva karma for
7 days.
c. Ayush-M (Glycyrrhiza glabra (Yasti madhu)- Two capsules (500 mg) twice a day with
water for two months
Duration of the study- Two months drug therapy with a follow up for one month without drug.
Period of Study: Three months for each case. Total duration will be one year to complete the
trial.
Follow – Up: One follow-up will be carried out after one month of the completion of
treatment.
1. Age between 20 years and 60 years
2. Both the sex
3. Patient with five or more attacks of Migraine(headache) without Aura lasting for 4-72
hours presenting with a) at least two of the features viz. i) unilateral, ii) Pulsating, iii)
Moderate to severe, iv) Aggravated by movement and b)at least one of the features viz.
i) Nausea, ii) Photophobia, iii) Phonophobia (Classification Committee of the International
Headache Society. Classification and diagnostic criteria for headache disorders, cranial
neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-96..}
1. Age below 20 and above 60 years
2. Less than five attacks of Migraine without Aura.
342
3. Clinically diagnosed cases of
a.. Tension headache
b. Cluster headache.
c. Idiopathic stabbing headache
d. Exertional headache.
e. Headache due to systemic infection.
f. Drug induced headache
4. Organic brain lesions
5. Systemic disorders
6. Person undergoing treatment for any other serious illness
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
the Performa (Forms I & II). Clinical assessment will be done before drug administration, at the
end of 1st month, 2nd month during treatment and at the end of 3rd month during follow up (Form
III). Required laboratory investigations will be carried out to exclude cases as specified in the
criteria for exclusion. Form-IV)
IX. CRITERA FOR ASSESMENT OF RESULT OF TREATMENT
Disappearance of headache and presenting clinical features i.e. (i) Unilateral, (ii) Pulsating,
(iii) Moderate to severe nature, (iv) Aggravated by movement, (v) Nausea, (vi) Photophobia &
(vii) Phonophobia will be considered as significant improvement.
Data on clinical symptoms, duration of attack and frequency of attack will be tabulated
and analysed using appropriate statistical tools.
343
XIII. ETHICAL REVIEW
Ethical Committee (IEC) of trial center for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at Hqrs
will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in
immediately to the PI and Data Monitoring Board 1) any life threatening conditions
whether they are perceived to be study related or not. The Board decides whether the
adverse effects warrant discontinuation of the study protocol. Protocols will be written and
approved for the treatment of study related adverse events
A consolidated amount of Rs……. /- per visit will be paid to subject selected for trial.
Short-term two-day training will be provided to the Investigators involved in the trial at
CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical trial conduct and
The Laboratory Investigations (Hematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
344
OUT AURA (ARDHAVA BEDHAKA)
CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial on “Assessment of Therapeutic Efficacy of Ayush-M Nasal Drops and Ayush-
M capsule in the management of Migraine with out Aura (Ardhava Bhedaka )

Relationship ___________________________________
345

Migraine (Ardhava Bedhaka) is as old as civilization, occupying 16% among clinical
classification of headaches, has become a challenging problem to the present day physician. Thee
is no satisfactory treatment available, since no drug is clearly superior then its potential side effect
are also considered A clinical study conducted on 20 cases migraine to evaluate the effect of
Nasya Karma with fresh leaf juice extracted from Acalypha indica Linn. (Haritamanjari,) along
with internal medication of Panchagavya ghrta (Astanga Hradya, Uttara Tantra 7/18) reveled
significant clinical improvement. Keeping the potential of Ayurveda into consideration, the present
study is aimed at evaluating an effective and safe remedy for the management and prevention of
migraine.
instructions scrupulously. The study will take approximately 3 months to complete (2 months for
treatment and another one month for follow-up study). During this period, you are expected to visit
the hospital three times, once in a month during drug treatment and once at the end of 3rd month
during follow up.
physical examination, Blood and urine samples will also be taken. This is to make sure that you
are eligible for the study.
If you are found eligible, you would be put on trial treatment for two months.
Initially for seven days nasal drops will be given to you for installation in nostril as per
guidelines issued by physicians. Daily dose of oral treatment consist of two 500 mg.
capsules twice a day for two months.
your next visit.
346
1. Centre: ………………..……….
6. Address ……………………………………..…………..........……………………………
1. Age below 20 years & upto 60 years
2. Both the sex
3. Five or more attacks of migraine (headache) without

Aura lasting for 4-72 hours
4. Presence of two or more of the following features
i) unilateral,
ii) Pulsating,
iii) Moderate to severe
iv) Aggravated by movement and
5. Presence of one or more of the following features
i) Nausea,
ii) Photophobia,
347
iii) Photophobia
7. Less than five attacks of Migraine without Aura
Clinically diagnosed cases of (S.No. 8 – 16)
8. Tension headache
9. Cluster headache
10. Idiopathic stabbing headache
11. Exert ional headache
12. Headache due to systemic infection
13. Drug induced headache
14. Organic brain lesions
15. Any systemic disorders
If Sl. No. 1 to 5 is ‘Yes’ and Sl. No. 6 to 16 are ‘No’
If admitted, Sr. No. of the Subject: _____________________
Date: _______________ Signature of the Investigator: ___________________
348
CASE RFPORT FORM II - HISTORY
1. Centre : ........................................
4. Name of the patient .............................................................................................................
5. Gender Male 1 Female 2
6. Address: ..............................................................................................................................
Exposed to allergens like dust, chemicals : ..............................................
Field work with physical labor : ..............................................................
Indicate nature of work : .........................................................................
11. Income per capita per month in rupees :
349
Chief complaints with duration Present (1) Absent (0)
12. Five or more attacks of Migraine (headache)

Aura lasting for 4-72 hours
13. Clinical features
14. Unilateral headache
15. Pulsating,
16. Moderate to severe
17. Aggravated by movement
18. Nausea
19. Photophobia,
20. Phonophobia
21. Average frequency of attacks of migraine per month
Zero One Two Three More than Three
22. Average duration of attacks of migraine (hours)
Less than five hours five to ten hours more than 10 hours
Personal History
23. Diet: Veg 1 Non-veg 2 Lecto-veg 3
24. Sleep: Normal (1) Duration in hours :____________
Abnormal (2) Duration in hours :____________
If Abnormal specify ______________________________________
No (0) Yes (1)
(a) Initiation:
(b) Maintenance:
(c) Freshness in the morning:
350
25. Anxiety
26. Constipation
Addiction
If yes specify: (a) Quantity [packs] ________________
(b) Total Duration in years ____________
If yes specify: (a) Quantity__________
30. Any other(specify)________________
31. Prakriti:
Vataj 1 Pittaj 2 Kaphaj 3
Vataja-Kaphaj 4 Vata-Pittaj 5 Pitta-Kaphaj 6
Sannipataj 7
32. Systemic examination: Normal 1 Abnormal 2
If abnormal, specify abnormalities __________________________________________
Date: _______________ Signature of Investigator: _________________________
351
[0, end of the Ist Month, IInd Month, IIIrd Month]
1. Centre : ........................................
5. Gender: Male 1 Female 2
6. Address: ..............................................................................................................................
Clinical Symptoms Present (1) Absent(0)
9. Unilateral headache
10. Pulsating headache
11. Nausea
12. Photophobia
13. Phonophobia
14. Frequency of attacks during last one month
Zero One Two Three More than Three
15. Duration of migraine attacks (hours):
Less than five hours five to ten hours more than ten hours
352
16. Adverse reaction: Yes 1 No 2
If yes, details:_______________________
Continuing 1
Drop out 2 Reason: _____________________________
Died 3 Cause: _______________________________
Date: ________________ Signature of the Investigator: ______________________
353
(BEFORE TREATMENT)
1. Centre : ........................................
6. Address: ..............................................................................................................................
9. Urine Examination: Routine____________ / Microscopic___________
10. TC (Cells/Cmm.)_____________________
11. DC: P (%)______ L (%)______ E (%)______ M (%)______B (%)______
12. Hb (g/dl) ______________
13. ESR (1st hour.)(mm) ______________
14. Blood Sugar – PP (mg./dl)______________
15. B. Urea (mg./dl) ______________
17. Uric acid (mg./dl) _______________
18. Lipid profile ______________
19. Liver function tests ______________
Date: ______________ Signature of Investigator _________________________
354
DOUBLE BLIND PLACEBO CONTROLLED
CLINICAL EVALUATION OF “AYURVEDIC CODED
DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”
Drug : Study Code:

AND SIDDHA
355
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356
DOUBLE BLIND PLACEBO CONTROLLED CLINICAL EVALUATION OF
“AYURVEDIC CODED DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”
I. BACKGROUND
Manasa mandata is a condition in which the normal growth of the child is affected and
this could be equated with mental retardation due to various reasons. According to Ayurveda this
deficiency occurs due to beeja dosha where the parents of the child might have had incompatible
and improper diet and habits, during and before their conjugation. According to ayurvedic
concepts vata or vayu (bodily bioforce) is the self-generating and self-propagating energy, which
is responsible for the conduct, regulation and integration of all vital functions and the structures of
the body. This vital force when imbalanced due to the above factors affects the development of
fetus and ends up with serious deformities to the child. Because if vata is in imbalanced stage,
definitely child will become mentally and/or physically abnormal. Ayurveda has mentioned the role
of doshaja (both sareeraka & manasika) and ajantuja factors in development of the disease
pathogenesis. The rajoguna &tamoguna (manasika dosha) along with vata, pitta, & kapha
(sareeraka dosha) will play an important role for the development of this disease.
Severity of Mental Retardation
Depending on the severity of intellectual impairment ICD –10 classifies the mental
retardation in to following degrees.
F 70 Mild mental retardation IQ of 50-69
F 71 Moderate mental retardation IQ of 35-49
F 72 Severe mental retardation IQ of 20-34
F 73 Profound mental retardation IQ < 20
The Intelligence quotient (IQ) score is used in the measurement of intelligence. IQ tests are
designed in such a fashion that an average individual gets a score of 100. As mentioned earlier, an
IQ of less than 70 is the criterion for falling in the range of mental retardation. Common IQ tests
that are used in India are Binet Kamat Test (BKT), Vineland Social Maturity Scale (VSMS),
Development Assessments scale for Indian Infants (DAS II), Seguin Form Board (SFB) and Malin
Intelligence Scale for Indian Children (MISIC).
II. OBJECTIVE
To study the efficacy of Ayush Manas for one year, in children with mental retardation in
terms of improving their intellectual function as measured by the IQ or SQ.
357
III. SAMPLE SIZE &METHODS
Study design: 12 months prospective double blind placebo controlled design is proposed. Patients
while e & f are optional / to selected patients.
Sample Size: Sample size would be 60 in active drug arm and 60 in the placebo group.
Drug/Dosage/ Duration
The subjects will be randomized to ayush Manas and placebo in a 1:1 ratio with
approximately 60 patients assigned to each group. Active treatment will be given for one year.
The drug Ayush Manas (250/tab) will be given at a dose of 2 tablets tid with water, which
contains equal parts of brahmi, manduka parni, jyothishmathi and ashwagandha.
Study procedures
Subjects will visit the investigator six times during the trial. The initial visit is screening phase
(visit 0), and subsequently after 1 to 4 weeks of initial wash out period (visit 1), after 3 months
(visit 2), 6 months (visit 3), 9 months (visit 4), 12 months (visit 5) and 6th visit will be at 15th
month. Visit 0 will be considered as the screening, visit I will be considered, as the baseline visit
where the trial begins and visit 5 will be the end of active treatment. On visit 1(base line visit), the
investigator after ensuring compliance with inclusion and exclusion criteria will propose the study to
the patient and obtain informed consent for each subject from the parent or guardian. A complete
medical history will be obtained. This will include patient demographics, significant past and present
illness or surgical procedures, concomitant medication data and VSMS – Malin’s version. A
physical examination will be done and include the recording of height, weight heart rate and blood
pressure. Diagnosis of Mental Retardation will be made according to VSMS – Malin’s version
criteria for Mental Retardation. Laboratory investigations will be done as per CRF (case recording
file) at base line (visit 1), after 3 months (visit 2) and at the end of the active treatment (visit5).
IV. CRITERIA FOR INCLUSION
1. Children of either sex aged in between 6 to 13 years.
2. Children with mild to moderate Mental Retardation.
V. CRITERIA FOR EXCLUSION
Children with a history of peptic ulcer disease, any gastric or duodenal surgery,
gasterointestinal (GI) bleeding or other GI disorders.
1. Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac
or hematological disorders.
2. Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2
mg/dl, SGOT, SGPT >2times uppr limit of normal; serum bilirubin or Alkaline phosphatase
>1.5 times upper limit of normal.
358
3. Subject’s guardian who cannot be relied upon to comply with the test procedures or are
unwilling to give informed consent.
4. The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4
weeks prior to study entry.
5. The Children has likelihood of requiring treatment during the study period with drugs not
permitted by the study protocol.
6. The Children with a history of recent and clinically significant drug abuse.
7. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia,
thrombocytopenia etc.
8. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to
return for follow-up visits, and unlikelihood of complete study.
9. Children in whom another investigational drug was used with in 3 months prior to entry in
this study.
10. Children with mental retardation suffering with active epilepsy (H/o attack in last 3 months).
11. Children to whom Binet Kamat Test (BKT) can’t be administered for any reason such as
speech delay, severe hyperkinesias etc.
VI. CRITERIA FOR WITHDRAWAL
A discontinuation occurs when an enrolled subject ceases participation in the study,
regardless of the circumstances, prior to completion of the study. The reason for withdrawal
should be recorded in the CRF, dated and signed. Efforts should be made to ascertain the reason
for discontinuation.
Discontinuation can be due to:
1. Non-compliance with the study medications and specified visits
2. Serious clinical events requiring specific treatment
3. At subject’s/ guardian’s request.
The final evaluation required by the protocol at the end of the study, will be performed at
the time of study discontinuation.
VII. ROUTINE INVESTIGATION AND ASSESSMENT
The following laboratory tests will be performed on at base line (visit 1), after 3 months
(visit 2) and at the end of the active treatment (visit5).
359
The laboratory tests include:
Hematology: Hemoglobin, haematocrit, RBC count, TLC, DLC, platelet count, erythrocyte
sedimentation rate (ESR), bleeding time, clotting time, prothrombin time.
Biochemistry: Total bilirubin, SGPT, SGOT, alkaline phosphotase, creatinine, blood sugar,
serum protein and albumin.
Urinanalysis: Albumin, microscopic haematuria, Urine for abnormal metabolites.
The laboratory test results will be recorded in CRF.
VIII. CLINICAL ASSESSMENT
Using study instruments in each visit will assess all Children who fulfill the inclusion and
exclusion criteria and whose parent/guardian provides written informed consent.
Instruments - a. Detailed clinical proforma for Mental Retardation
b. Binet Kamat Test (BKT)
c. Vineland Social Maturity Scale (VSMS) – Indian adaptation by Malin
d. Maladaptive Behavior Scale (Part II of ABS of AAMR)
e. Seguin Form Board (SFB)
f. Malin’s Intelligence Scale for Indian Children (MISIC)
a, b, c & d will be administered to all the patients while e & f are optional / to selected patients.
SAFETY RECORDING
a. Adverse Events
All adverse events observed or reported by patients will be recorded in the CRF with
information about severity (i.e., whether mild, moderate or severe) and possible relation to the
study medication. Any serious adverse effects must be notified immediately to the study monitor.
b. Safety Measures
Safety evaluation will perform by recording clinical adverse events at randomization
(baseline) and at the subsequent clinical visits. Further adverse events will be classified according
to their type, severity and possible relationship to treatment. At Visit 1 the subject’s medical history
will be recorded. At monthly visits vital signs (body temperature, pulse, blood pressure) will be
recorded and a physical examination will be performed (Abnormal Lab reports listed in appendix
3).
360
IX. TRIAL MONITORING AND DATA ANALYSIS
A qualified statistician will perform the statistical analysis. All available data will be used in
the analysis. In general all statistical tests will be performed at the 5% level of significance.
X. ETHICAL REVIEW
Ethics Committee: The study will be performed in accordance with the principles stated
in the Declaration of Helsinki (enclosed Appendix 2). Ethical approval of the study protocol will
be obtained from the Ethics committee at institutions where the study will be conducted before the
study is undertaken. The opinion of the Ethics Committee should be dated and given in writing.
Whenever possible, the names and titles of the members attending the Ethics Committee meeting
should be appended. The approval must clearly identify the protocol and other documents
submitted for review, by title and study code.
XI. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
screening, 1st, 2nd, 3rd month (4 times)
XII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
XIII. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Haematological /Biochemical, etc.), which are not available
361
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”

The research study in which patient participation is suggested aims to assess the efficacy
and safety of a new drug called AYUSH MANAS, a herbal product.
Currently no available drug has proven efficacy to improve the overall intellectual
functioning. Many patients seek alternative methods of treatment (complementary medicine). There
is thus a definite need to scientifically assess some of these treatment modalities. Though there are
no published data available on the efficacy of these herbs in mental retardation, the long claimed
usage in complementary medicine in India, claimed efficacy in mental performance, the apparent
safety profile makes it worthwhile studying in a placebo controlled randomized double blind trial.
The individual components of AYUSH MANAS have been studied in India & abroad in
various institutes in open clinical trials for disorders of the nervous system, memory improvement,
and development of immunity.
Explanation of procedures to be followed
Study procedure
I agree to return to this institute for examinations and evaluations of my child’s response to
treatment. At this initial visit my child’s medical and psychiatric history, current condition and
eligibility to enroll in this study will be evaluated. Approximately 5 more visits will be required to
assess my child throughout this study. Visits will take approximately one or two hours.
During these visits, a complete clinical assessment including physical examination,
psychological tests, & behavior rating scales, compliance with therapy and reporting of any
adverse reactions will be recorded.
Laboratory tests will be performed on first, second and last visits.
My child will be receiving either AYUSH MANAS or placebo (inactive drug). Neither my
physician nor I will know what medication my child is receiving. The physician will however be
able to obtain this information, quickly if needed.
Expected duration of the study and number of patients expected to participate
My child will be one of 120 patients who will participate in this study. The study
medication will be administered orally daily for a period of one year.
Possible risks
Based on our clinical experience the drugs included in AYUSH MANAS have shown no
side effects for short and long-term therapy.
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Problems and side effects, which are not known at this time, could occur. I will be told of
any changes in the way the study will be done and of any newly identified risks to which my child
may be exposed.
I shall inform the physician about any illness that my child may have suffered in this study
period and the treatment required for it.
Patient participation
Participation in this study is entirely voluntary. If I do not desire to enroll my child for the
study the child’s treatment will continue as per the routine of the institute.
Possible benefits of the study
The costs of the all tests, examinations and medical care required as a part of this study
are to be provided free of cost to me. My child may respond favorably to treatment and others
may benefit from the overall conclusions to be drawn from the results of this study. There is no
guarantee that my child will benefit from participating in this study.
Withdrawal from this study
The investigator in charge of this study can remove my child from the study without my
consent based on his/her judgment to improve my child’s medical care or my failure to follow the
study schedule.
Compensation
If my child is injured as a direct result of taking part in this study, I understand that
medical treatment and other related costs should be made available by CCRAS, New Delhi.
Right to withdraw from the study
I am free to leave this study at any time without giving any reason. My decision of not
participating in this study or to leave the study in between shall not affect my child’s future medical
care.
Confidentiality
The records obtained during the study as well as related health records will remain strictly
confidential at all times. However, I understand that these will need to be made available to
CCRAS, New Delhi, to other doctors/scientists of this study and if required to the drug regulatory
authority. The information disclosed will remain confidential. The results of the treatment, including
laboratory tests, photographs may be published for scientific purposes provided my child’s identity
is not revealed.
Data protection: Use of data collected from this study
My child’s personal data, which may be sensitive, will be collected and processed only for
research purposes in connection with this study. By taking part in this study, I agree not to restrict
the use of any data even if I withdraw.
363
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”
(By parent/guardian of the patient)
I,…………………………………………………………………………………………Father/
Mother/Guardian of………………………………………, exercising my free power of choice
give my consent on my as well as my child’s behalf to be included in this study on one-year
prospective double blind placebo controlled clinical evaluation of “Ayurvedic coded drug (AYUSH
MANAS)” in the management of “Manasa Mandata (Mental Retardation)”. I have read, or had
read to me, the above information before signing this consent form. I have been provided ample
opportunity to ask questions and have received answers that fully satisfy those questions. I have
been informed to my satisfaction by the attending physician the nature and purpose of the study.
I understand that the clinical details and information recorded as part of the study will be
kept confidential.
I am also aware of my right to withdraw out of this study at any time during the course of
the study without having to assign the reason for doing so.
Signature of the Father/Mother/Guardian Date: ________________
Signature of the Physician Date: ________________
Signature of impartial witness Date: ________________
364
CENTRAL COUNCIL FOR RESEARCH IN A YURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – I SCREENING
1. Name of the patient : ______________________________________________________

2. Address: _______________________________________________________________
_______________________________________________________________
3. Centre: _______________________________________________________________
5. Patient No. ______________________________________________________________
Third Fourth
1. Age between 5-16 years of either sex 1 0
2. Duration of disease up to 10 years 1 0
3. Presence of cardinal symptoms of diseases 1 0
CRITERIA OF EXCLUSION
4. Age below 5 and above 16 years 1 0
5. Duration more than 10 years 1 0
6. Patients with uncontrolled epilepsy, hyperkinesis, 1 0
psychosis, tuberculosis and organicity
7. Others (specify)_________________________________________
A patient will be admitted for treatment,
If ‘Yes’ to 1 – 3 and ‘No’ to 4 – 7 above
No: _ _ _ _ _ _ _ _ _ _ _ _
Date: _____________ Signature of the Investigator _______________________
365
CASE RFPORT FORM II - HISTORY
1. Name of the patient : ______________________________________________________
2. Address : _______________________________________________________________
_______________________________________________________________
4. Centre : __________________________________________________________________
5. Code No. (of clinical trila) :
6. Patient No.
7. Group No. First 1 Second 2
Third 3 Fourth 4
8. Age in patient in years : _______________
9. Educational status:
Illiterate 1 Read and write 2 Primary 3
Middle school 4 High school 5 College 6
Others (specify) 7 INA 8
10. Occupation
Desk work 1 Field work 2
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Total income of the family in rupees : .......................................................
Chief complaints with duration Yes (1) No (0)
13. Delayed milestones 1 0
14. Speech handicap 1 0
15. Seizures 1 0
16. Mental age not proportional with chronological age 1 0
17. Adaptive behavior Impaired 1 Not impaired 0
18. Hyperactivity present 1 absent 0
19. Maladaptive signs (tick if present)
Twitches & tics

Silly giggling
Dribbling of the saliva
Destructive & harmful
Inopportune laughing/crying/shouting
Fixed eyes
Lack of personal hygiene
History of present illness:
20. Onset of disease Acute 1 Insidious 2
21. Duration of disease ______________
22. Treatment given so far :
Ayurvedic medicine 1 Modern medicine 2 Unani 3
Homoeopathy 4 Siddha 5 Mixed 6
367
Medicines given ________________________ Results obtained ______________________
23. Factors aggravating the disease/chief complaints ___________________________________
24. Factors relieving main complaints_______________________________________________
25. History of past illness having relation with present illness
Yes 1 No 2
If yes, specify _____________________________________________________________
Family History if any Yes (1) No (0)
26. Mental disease 1 0
27. Mental retardation 1 0
28. Consanguineous marriage 1 0
Personal History
29. Diet: Veg 1 Non-veg 2 Lacto-ova veg 3
30. Sleep: Good 1 Disturbed 2 Insomnia 3
31. Emotional stress Yes 1 No 2
32. Bowel Habit Regular 1 Constipation 2 Loose motion 3
33. Addiction Yes 1 No 2
If yes, specify _____________________________________________________________
34. Prakriti
Vataja-Kaphaj 4 Vata-Pittaj 5 Pitta-Kaphaj 6
Sannipataj 7
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35. Manas Prakriti
Sattva 1 Rajas 2 Tamas 3
Sattva-Rajas 4 Sattva-Tamas 5 Rajas-Tamas 6
Sama 7
Physical Examination:
Build Lean 1 Medium 2 Heavy 3
36. Body weight Kg: _________________
37. Blood Pressure (Systolic): _________________
38. Blood Pressure (Diastolic): _________________
39. Body temperature: _________________
40. Respiration: _________________
41. Cyanosais 1 0
42. Anaemia 1 0
43. Jaundice 1 0
44. Pigmentation 1 0
45. Clubbing of fingers 1 0
46. Deformities 1 0
47. Lymphadenopathy 1 0
48. CVS with chest 1 2
If abnormal, specify abnormalities_______________________________________________
49. CNS 1 2
If abnormal, specify abnormalities__________________________________
369
50. Digestive System 1 2
51. Urogenital System 1 2
Samprapti (Pathogenesis) of the disease
52. Anubandhyashareerikadosha Vata 1 Pitta 2 Kapha 3
53. Anubandhashareerika dosha Vata 1 Pitta 2 Kapha 3
54. Anubandhya manasika dosha Rajas 1 Tamas 2
55. Anubandhamanesika dosha Rajas 1 Tamas 2
56. Ksheena shareerika dosha Vata 1 Pitta 2 Kapha 3
57. Ksheena manasika dosha Rajas 1 Tamas 2
58. Stages of disease (Rogakriya kala)
Sanchaya 1 Prakopa 2 Prasara Sthanasamshraya 3
Vyakti 4 Bheda 5
SROTAS PAREEKSHA
59. Pran Vaha Srota
Alpa Alpa Swasa (Shortened Breathing) 1
Atisrama Swasa (Increased respiration rate) 2
Abhikshna Swasa (Chyne stroke breathing) 3
Kupita Swasa (Vitiated breathing) 4
Sashula swasa (Dyspnoea with pain) 5
60. Udakavaha Srota
Jihva sosha (Dryness of tongue) 1
370
Oustha sosha (Dryness of lip) 2
Talu shosha (Dryness of palate) 3
Kantha shosha (Dryness of throat) 4
Kloma shosha (Excessive thirst) 5
Trishna (Thirst) 6
61. Annavaha Srota
Anannabhilasha (Lack of desire for food) 1
Aruchi (Anorexia) 2
Avipaka (Indigestion) 3
Chhardi (Vomitting) 4
62. Ras Vaha Srotas
Mukha vairsya (Bad taste in mouth) 1
Arasajnata (Tastelessness) 2
Hrillasa (water brash) 3
Gaurava (Feeling of heaviness) 4
Tandra (Stupor) 5
Anga marda (Body ache) 6
Jwara (Fever) 7
Pandu (Anaemia) 8
Avsada (Depression) 9
Klaibya (Loss of libido) 10
Karshya (Emaciation) 11
Agnimandya (Diminished appetite) 12
371
63. Rakta Vaha Srotas
Pidika (Boils) 1
Rakta Pitta (Bleeding from any of the orifice) 2
Mukha paka (Stomatitis) 3
Vidradhi (Abscess) 4
Charma raga (Skin disease) 5
Kamala (Jaundice) 6
64. Mamsa Vaha Srotas
Arubuda (Tumour) 1
Aljee (Phlyctenular conjunctivitis) 2
Gandamalaa (cervical lynphadenitis) 3
Upjivihika (Epiglotitis) 4
Adhimamsa (Protruberance of flesh/cancer/cyst) 5
Putimamsa (decayed flesh/gangrene) 6
65. Medo Vaha Srotas -
Maladhykya (Excess of excreta) 1
Hastapada daha (Burning sensation in the palm and sole) 2
Hastapada suptata (Numbness of the palm and sole) 3
Tandra (Stupor) 4
Dehachikkanata (Greasiness of the skin) 5
Alasya (Lethargy) 6
66. Asthi Vaha Srotas -
Adhyasthii (Hypertrophy of bone) 1
372
Adhidanta (Redundant tooth) 2
Dantshoola (Toothache) 3
Asthi shoola (bone pain) 4
Kesha, lorna, nakha, samshru vikara 5

67. Majja Vaha Srotas -
Parva shoola (Pain in the Interphalangeal joints) 1
Bhrama (Vertigo/Giddiness) 2
Moorchh (Syncope) 3
Mithyajnana (Illusion) 4
68. Shukra vaha srotas -
Klaivya (Sterility/impotence) 1
Aharshan (Loss of erection) 2
Garbha pata (Abortion) 3
Santana vikriti (Congenital deformity of the children) 4
69. Manovaha srotas
Manovibramsha 1
Budhivibramsha 2
Samjavibramsha 3
Smritivibramsha 4
Bhktivibramsha 5
Sheelavibramsha 6
Chesta vibramsha 7
Acharavibramsha 8
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70. Artava vaha srotas -
Anartava (Amenorrhoea) 1
Vandhyatva (Sterlity) 2
71. Mutra-vaha srotas -
Bahumutrata (Polyuria) 1
Atibadhta (Urination with obstruction) 2
Prakop mutra (Defective Urination/Difficulty in micturition 3
Alpaalpa (Scanty urination) 4
Aabhikshna (Constant/repeated urination) 5
Bahulamutrata (Urine with prostatic secreation) 6
Sashoola mutrata (Painful micturition) 7
72. Pureeshavaha srotas -
Alpaalpa pureesha (Scanty defecation) 1
Sashoola pureesha (Painful defecation) 2
Atidrava pureesha (Diarrhoea) 3
Atigrathita yukta pureesha (Scybala) 4
73. Sweda vaha srotas -
Aswedan (Loss of perspiration) 1
Atiswedana (Profuse sweating) 2
Parushya (Roughness of the skin) 3
Lomaharsha (Thrill) 4
Aangaparidaha (Burning sensation in the body) 5
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74. Investigations
Clinical assessment
75. Provisional diagnosis Final diagnosis
76. Medical management
77. Principle drug therapy
Drug Dose Vehicle Diet
Duration of treatment
78. Summary of findings
79. Results: Good response 1 Fair response 2
Poor response 3 No response 4
Dropout 5 LAMA 6
Death 7
Date:____________ Signature of Investigator___________________________
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MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – III INVESTIGATION
1. Name of the patient: ________________________________________________________
2. Address: _______________________________________________________________
_______________________________________________________________
3. Centre: __________________________________________________________________
4. Code No. (of clinical trial):
5. Patient No.
7. Age of patient in years: _____________________________________________________
Investigations
Investigations At the time of admission At the time of discharge
8. URINE: Routine & Microscopic
9. Stool: Macroscopic & Microscopic
HAEMA TOLOGICAL INVESTIGATIONS
10. HB %
11. T.L.C. (in thousands/Cmm)
12. D.L.C.
Polymorphs :..... .....%
Lymphocyte :..... .....%
Basophil : . . . . . . . . . . %
Eosinophil : . . . . . . . . . . %
376
13. E.S.R. : 1 Hr . . . . . . . mm
: 2 Hr . . . . . . . mm
Biochemistry:
14. Total proteins (gm % )
15. Alkaline phosphatase . . . . . . . . . IU/L
16. S.G.O.T . . . . . . . . . IU/L
17. S.G.P.T . . . . . . . . . IU/L
18. S. Bilirubins . . . . . . . . . mg/100 ml
19. Urea . . . . . . . . . mg/100 ml
20. S. Creatinine . . . . . . . . . mg/dl
Special Tests
21. Urinary catecholamines
22. CT Scan for Head
23. EEG
Note: Only such investigations are to be undertaken for which facilities exist in the Institutes/
Centres/Units themselves, unless exempted.
24. Objective test
(i) Binet Kamat test
(ii) Seguin Form Board Test
(iii) Vineland Social Maturity Scale
377
INFORMED CONSENT (APPENDIX 1)
Informed consent will be obtained from each subject in the prescribed format prior to
performance of any study related procedures: before physical examination, laboratory screening or
any other investigational procedure and before administration of any study related medication. The
investigators will give each subject full information about the nature, meaning and importance of the
study and a description of the procedures to be followed by the investigator in accordance with
Declaration of Helsinki (Appendix 2). They will further be given a description of any foreseeable
risks and discomforts. Subjects will also be told that they have the right to opt out of the trial at
any time without having to give reasons and without prejudice to further treatment. Each subject
will be given a copy of the subject information sheet and will be given sufficient time to consider
the implications of the study before deciding whether or not to participate in the trial.
The subject and the investigator must sign the informed consent form. At this time the
subject must have legal capacity and be able to comprehend the nature, meaning, importance and
risks of the study and to make up his mind accordingly. If the subject is illiterate, an impartial
witness (a person, who is independent of the trial and who cannot be unfairly influenced by people
involved in the trial) will attend the informed consent form in a language known to the subject.
Signed informed consent means the explicit acceptance that the Investigator(s), the sponsor and,
possibly, the regulatory authorities, will know about the individual’s data.
Note: In the above Subject means parent’s Legal guardian.
378
DECLARATION OF HELSINKI (APPENDIX 2)
Introduction
It is the mission of the physician to safeguard the health of the people. His or her
knowledge and conscience are dedicated to the fulfillment of this mission.
The Declaration of Geneva of the World Medical Association binds the physician with the
words, “The health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act only in the patient’s interest when providing
medical care which might have the effect of weakening the physical and mental condition of the
patient.”
The Purpose of biomedical research involving human subjects must be to improve
diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and
pathogenesis of disease.
In current medical practice most diagnostic, therapeutic or prophylactic procedures involve
hazards. This applies especially to biomedical research.
Medical progress is based on research, which ultimately must rest in part on
experimentation involving human subjects.
In the field of biomedical research a fundamental distinction must be recognized between
medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical
research, the essential object of which is purely scientific and without implying direct diagnostic or
therapeutic value to the person subjected to the research.
Special caution must be exercised in the conduct of research, which may affect the
environment, and the welfare of animals used for research must be respected.
Because it is essential that the results of laboratory experiments be applied to human
beings to further scientific knowledge and to help suffering humanity, the World Medical
Association has prepared the following recommendations as a guide to every physician in
biomedical research involving human subjects. They should be kept under review in the future. It
must be stressed that the standards as drafted are only a guide to physicians all over the world.
Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their
own countries.
I. Basic Principles
Biomedical research involving human subjects must conform to generally accepted scientific
principles and should be based on adequately performed laboratory and animal experimentation
and on a thorough knowledge of the scientific literature.
379
1. The design and performance of each experimental procedure involving human subjects should
be clearly formulated in an experimental protocol which should be transmitted for
consideration, comment and guidance to a specially appointed committee independent of the
investigator and the sponsor provided that this independent committee is in conformity with
the laws and regulations of the country in which the research experiment is performed.
2. Biomedical research involving human subjects should be conducted only by scientifically
qualified persons and under the supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a medically qualified person and
never rest on the subject of the research, even though the subject has given his or her
consent.
3. Biomedical research involving human subjects cannot legitimately be carried out unless the
importance of the objective is in proportion to the inherent risk to the subject.
4. Every biomedical research project involving human subjects should be preceded by careful
assessment of predictable risks in comparison with foreseeable benefits to the subject or to
others. Concern for the interests of the subject must always prevail over the interests of
science and society.
5. The right of the research subject to safeguard his or her integrity must always be respected.
Every precaution should be taken to respect the privacy of the subject and to minimize the
impact of the study on the subject’s physical and mental integrity and on the personality of
the subject.
6. Physicians should abstain from engaging in research projects involving human subjects unless
they are satisfied that the hazards involved are believed to be predictable. Physicians should
cease any investigation if the hazards are found to outweigh the potential benefits.
7. In publication of the results of his or her research, the physician is obliged to preserve the
accuracy of the results. Reports of experimentation not in accordance with the principles laid
down in this Declaration should not be accepted for publication.
8. In any research on human beings, each potential subject must be adequately informed of the
aims, methods, anticipated benefits and potential hazards of the study and the discomfort it
may entail. He or she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his or her consent to
participation at any time. The physician should then obtain the subject’s freely-given informed
consent, preferably in writing.
9. When obtaining informed consent for the research project the physician should be particularly
cautious if the subject is in a dependent relationship to him or her or may consent under
duress. In that case the informed consent should be obtained by a physician who is not
engaged in the investigation and who is completely independent of this official relationship.
380
10. In case of legal incompetence, informed consent should be obtained from the legal guardian
in accordance with national legislation. Where physical or mental incapacity makes it
impossible to obtain informed consent, or when the subject is a minor, permission from the
responsible relative replaces that of the subject in accordance with national legislation.
Whenever the minor child is in fact able to give a consent, the minor’s consent must be
obtained in addition to the consent of the minor’s legal guardian.
11. The research protocol should always contain a statement of the ethical considerations involved
and should indicate that the principles enunciated in the present Declaration are complied
with.
II. Medical Research Combined with Professional Care (Clinical Research)
1. In the treatment of the sick person, the physician must be free to use a new diagnostic and
therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health
or alleviating suffering.
2. The potential benefits, hazards and discomfort of a new method should be weighed against
the advantages of the best current diagnostic and therapeutic methods.
3. In any medical study, every patient—including those of a control group, if any—should be
assured of the best proven diagnostic and therapeutic method.
4. The refusal of the patient to participate in a study must never interfere with the physician-
patient relationship.
5. If the physician considers it essential not to obtain informed consent, the specific reasons for
this proposal should be stated in the experimental protocol for transmission to the independent
committee (I, 2).
6. The physician can combine medical research with professional care, the objective being the
acquisition of new medical knowledge, only to the extent that medical research is justified by
its potential diagnostic or therapeutic value for the patient.
381
ABNORMAL LABORATORY RESULTS (APPENDIX 3)
SI.No. Laboratory Test Clinically Moderate Marked

relevant abnormality abnormality
direction (%) (%)
1. Haemoglobin (Hb) Decrease 10(5) 25(10)
2. Haematocrit Decrease 10(5) 25(10)
3. RBC Either 10(5) 25(10)
4. White cell (TLC) Either 10(5) 25(10)
5. Platelet Decrease 10(10) 25(25)
6. Creatinine Increase 10(5) 50(50)
7. Glucose Either 10(20) 50(50)
8. Total bilirubin Increase ≥1.5xULN ≥2.0xULN
9. AST/ALT Increase ≥1.5xULN ≥3.0xULN
10. Alkaline phosphatase Increase ≥1.2xULN ≥1.5xULN
11. Abnormal laboratory
value follow-up
Patients with markedly abnormal tests at the end of treatment period should be followed
up to satisfactory resolution.
ULN is defined as the upper limit of normal, depending on whether the pretreatment
baseline was normal or abnormal.
The follow up of abnormal laboratory tests described in the CRF will be recorded
accordingly.
382
SCHEDULE OF ASSESSMENTS (APPENDIX 4)
Assessment Screening Double Blind Treatment Follow Up

Visit No. 0 1 2 3 4 5 6
Inclusion/Exclusion X - - - - - -
criteria
Medical History X - - - - - -
BKT X - - - - X X
VSMS X - X X X X X
Part II of ABS of X - X X X X X
AAMR
SFB X - X X X X X
MISIC X - X X X X X
Pulse/BP/Weight/Height X X X X X X X
Physical Examination X X X X X X X
Clinical Lab. Evaluation X - X - - X -
Study drug accountability - X X X X X -
383
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384
SAMANA THERAPY VIS-A-VIS PANCHAKARMA
THERAPY IN THE MANAGEMENT OF GRIDHRASI
(SCIATICA)
Drug : Study Code:

AND SIDDHA
385
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386
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
I. BACKGROUND
Pain starting from the gluteal region and spreading down the back of the lower limb and
radiating upto the foot is the main symptom of the Gridhrasi (Sciatica). There will be a limp gait
and difficulty in sitting. If pain is severe, the patient may not be able to move from bed. The pain
increases by coughing or sneezing. The patient suddenly seized with immobilizing and shooting pain
down the leg, starting from lower back.
The disease mostly affects the early and middle aged people. Occupations like heavy
weight lifting, continuous pressure on the back etc. are also main causative factors.
ETIOPATHOGENESIS
According to Ayurveda, in Gridhrasi1, the main vitiated Dosha is Vata. In Ashtanga
Hridaya and Sushruta Samhita, the descriptions of Gridhrasi are identical. However, Caraka’s
description differs. It classifies Gridhrasi into two types namely Vataja and Vatakaphaja.
Caraka’s description is very much similar to modern concept. According to Ayurvedic concepts
also, the origin of the disease is at Katipradesha (Lumbo - Sacral region).
Inspite of the fact that the spinal diseases are difficult to be cured, sciatic pain is not so
much harmful as other neurological conditions. Ayurvedic concept of treatment for Gridhrasi
(Sciatica) is more effective and suitable as compared to modern mode of treatment. On prolonged
use also, there is no side effect with Ayurvedic regimen of treatment. Several single and compound
herbal preparations like Bhallataka (Tripathy et. al., 1965). Nirgundi (Jain et. al., 1976) and
Hingutriguna Taila (Prem Kishore et. al., 1986) etc. have shown good response in the
management of Gridhrasi (Sciatica).
References
1. Charaka Samhita, Chikitsa Sthana Chapter– 28, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
Shastry, Choukhamba Orientalia, Varanasi
2. Harrison’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by Mc Graw-Hill CompaniesInc.pp1208-1209
3. Ambika Dutta Sashtri (1989) Susruta samhita (text with Hindi commentary) Nidana Sthana,
Chapter – 1, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
387
Since inception, Indian Institute of Panchakarma has been concentrating Clinical
Research Trials on Gridhrasi in order to find out an effective line of treatment. Several Single and
Compound Ayurvedic preparations had been tried. Following are the main drugs in which Clinical
Trials have been already conducted in past. All the trials have shown significant result in the
management of Gridhrasi cases.
Typical pain radiation, caused due to irritation of the 4th and 5th lumber and 1st sacral
roots, from the sciatic nerve extending mainly down the posterior aspect of the thigh and posterior
and lateral aspects of the leg is termed as Sciatica. Twinkling, paresthesia and numbness of or
sensory impairment of the skin, soreness of the skin and tenderness along the nerve also
accompanies the classic sciatic pain and on physical examination reflex loss, weakness, atrophy,
fascicular twitching and occasionally stasis oedema may occur is the motor fibres of the anterior
root are involved.
Mild attacks least for a week or two. Other cases happen to be more chronic and
provide a history of remitting attacks. Favorable cases, rested absolutely on hard bed, may
recover with 4 – 6 weeks but recurrences are frequent. Foot drops seldom recovers completely.
Pelvic tractions help in some cases with disc lesions. Massage, spinal exercise and heat application
provide comfort and hence are useful. If there is no improvement by providing bed rest and there
are recurrent disabling attacks, surgical removal of the disc is suggested.
II. OBJECTIVES
The study aims to assess the Comparative Clinical Evaluation of Dasamoola Bala Kwatha
(Internal) along with Dasamoola Bala Taila (Internal and External) in one group and
Panchakarma Therapy with its different procedures in another group in the management of
Gridhrasi (Sciatica). The drug Dasamoola and Bala are well known for their Vatahara
properties.
III. CENTER:
Sample Size: 100 cases
No of Groups: Two groups
Trial Drug/Dosage/Duration
Group – I: Samana Chikitsa
a). Dasamoola Bala Taila – 10 ml. to 15 ml. thrice daily X 14 days.
i). Dasamoola Bala Kwatha – 10 – 15 ml. thrice daily X 14 days.
388
ii). Nirgundi Patrapotala Sweda after Abhyanga with Dasamoola Bala
Taila X 14 days.
b). Virechana X 1 day with Eranda Taila 30 ml., after completing the
Patrapotala Sweda
Group – II: Panchakarma Therapy

a). Snehapana with Dasamoola Bala Taila for 7 days
b). Vashpa Sweda X 3 days
c). Viechana with Eranda Taila X 1 day
d). Samsarjana Karma X 7 days
e). Vaitarana Vasti X 7 days
No of Patient in each Group: 50 cases in each group
(Random allocation of selected cases in two different trial groups)
Type of Study: Single blind
Duration of Study: Samana Chikitsa for a period of 22 days while Panchakarma
Chikitsa will continue for a total period of 25 – 26 days.
Follow Up: For a period of three months on a regular interval of fortnight, either with
postal correspondence or on personal appearance of the patient at the field station where
he/she has been registered for the trial.
1. Age — 20 to 70 years
2. Sex — Either sex
3. Duration of illness — Upto 2 years
4. Radiating pain, starting from the gluteal region towards, the foot
5. Tenderness of the Sciatic Nerve course
6. Severe pain on squatting
7. Sensory change
8. Non-involvement of Urinary Bladder and Rectum
9. Positive straight leg raising sign
389
2. Duration of disease more than 2 years
3. Monoplegia
4. Paraplegia
5. Hip joint arthritis
6. T.B. Spine/Hip
7. Pelvic pathology
8. Traumatic lesion in lumbo - sacral region
1. Left against medical Advise (LAMA)
2. Development of complications due to presenting illness or otherwise
3. Aggravation of symptoms
Pronounced toxic side effects
Screening of the patient will be recorded as per case record form - I. Detailed clinical
history and physical examination of each patient will be recorded as per Part – II of the Proforma
annexed. Pathological, Biochemical and other relevant investigations will be carried out as per Part
– III of the proforma. The assessment of the results will be done according to effect of the Trial
Groups on each of the sign and symptom. Each sign and symptom is graded and a numerical
value is given for assessment of results. (as per case record form III).
Following criteria has been fixed for Routine Examination and Assessment.
1. Pricking pain 6
2. Pulling pain 6
3. Stiffness 3
4. Tenderness of sciatic trunk 6
5. Straight leg raising test/positive 54
jugular vein pressure test
6. Ankle jerk 2
390
7. Knee jerk 2
8. Plantar reflexes 2
9. Pressing power 3
10. Muscle wasting 3
11. Walking speed 3
12. Sensory impairment 2
13. Posture 8
Total 100
Symptoms were suitably graded to assess the degree of involvement. The assessment chart
is annexed at Part – IV of the Proforma.
Result of treatment will be graded as follows:
1. Good Response : Complete relief in presenting symptomatology of the disease.
2. Fair Response : 75% and above relief of signs and symptoms.
3. Poor Response : 50% to 74% relief of signs and symptoms
4. No Response : No response in presenting clinical symptomatology of disease or
otherwise.
X. TRIAL MONITORING AND DATA ANALYSIS
The progress of the study will be monitored by team comprising of Clinicians, Pathologists,
Biochemists, Radiologists and Statisticians.
XI. STATISTICAL ANALYSIS
Before treatment and after treatment, data signs/symtoms and other parameters taken into
account for diagnosis and assessment of result of treatment will be tabulated and analyzed using
suitable statistical methods.
XII. TRIAL MONITORING AND DATA ANALYSIS
analysis.
391
XIV. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
XV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
uniformity.
XVI. LABORATORY INVESTIGATIONS
392
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Samana therapy vis-a-vis panchakarma therapy in the management
of gridhrasi (sciatica)”
Relationship ___________________________________
393
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE

Pain starting from the gluteal region and spreading down the back of the lower limb and
radiating upto the foot is the main symptom of the Gridhrasi (Sciatica). There will be a limp gait
and difficulty in sitting. If pain is severe, the patient may not be able to move from bed. The pain
increases by coughing or sneezing. The patient suddenly seized with immobilizing and shooting pain
down the leg, starting from lower back.
The disease mostly affects the early and middle aged people. Occupations like heavy
weight lifting, continuous pressure on the back etc. are also main causative factors.
According to Ayurveda, in Gridhrasi, the main vitiated Dosha is
Vata. In Ashtanga Hridaya and Sushruta Samhita, the descriptions of Gridhrasi are
identical. However, Caraka’s description differs. It classifies Gridhrasi into two types namely
Vataja and Vatakaphaja. Caraka’s description is very much similar to modern concept.
According to Ayurvedic concepts also, the origin of the disease is at Katipradesha (Lumbo -
Sacral region).
Inspite of the fact that the spinal diseases are difficult to be cured, sciatic pain is not so
much harmful as other neurological conditions. Ayurvedic concept of treatment for Gridhrasi
(Sciatica) is more effective and suitable as compared to modern mode of treatment. On prolonged
use also, there is no side effect with Ayurvedic regimen of treatment. Several single and compound
herbal preparations like Bhallataka (Tripathy et. al., 1965). Nirgundi (Jain et. al., 1976) and
Hringutriguna Taila (Prem Kishore et. al., 1986) etc. have shown good response in the
management of Gridhrasi (Sciatica).
instructions scrupulously. The study will take approxim. Samana Chikitsa for a period of 22 days
while Panchakarma Chikitsa will continue for a total period of 25 – 26 days.
During treatment period, you are expected to visit the hospital for clinical and physiological
assessment.
394
also be done.
If you are found eligible, you would be put on treatment for Samana Chikitsa for
a period of 22 days while Panchakarma Chikitsa will continue for a total period of 25 –
26 days.
395
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
BEFORE TREATMENT
1. Name of the patient: .................................................... Age: ................. Sex: ...................
2. Address: ...............................................................................................................................
3. Centre:
5. Patient No.
6. Group No
7. Age between 12 – 70 years 1 0
8. Sex – Either sex 1 0
9. Duration of illness upto 2 yrs. 1 0
10. Regarding pain starting from gluteal region 1 0
11. Tenderness of sciatic nerve course 1 0
12. Severe pain on squatting 1 0
13. Positive straight leg raising sign 1 0
CRITERIA FOR EXCLUSION Yes No
14. Age below 12 and above 70 years 1 0
15. Duration of the disease more than 2 years 1 0
396
16. Monoplegia 1 0
17. Paraplegia 1 0
18. Hip joint arthritis 1 0
19. T.B. Spine/Hip 1 0
20. Pelvic pathology 1 0
21. Traumatic lesion in lumbosacral region 1 0
Date: ________________ Name of Investigator: _____________________
397
1. Name of the patient : ............................................................ Age ............ Sex .................
2. Address : ..............................................................................................................................
4. Centre :
6. Patient No.
7. Group No
8. Age of Patient (in years)
Illiterate Read and write Primary
398
Christian 4 Parsi 5
Chief Complaints with Duration (as indicated in days)
14. Sphik sula/Katisula/Prishta sula 1 0
15. Urasula (Pain on back of thigh) 1 0

(Sciatic Course)
16. Janghasula (Pain in calf muscle) 1 0
17. Padasula (Pain in foot) 1 0
18. Pain on raising from squatting 1 0
19. Thota (Pricking pain) 1 0
20. Graha (Pulling pain) 1 0
21. Spandana (Twitching) 1 0
22. Walking difficulty 1 0
23. Stambha (Stiffness) 1 0
24. Supti (Numbness) 1 0
25. Nidranasa (Distrubed sleep) 1 0
History of Present Illness
Duration of disease (in days)
27. Treatment given so far: Ayurvedic medicine 1 Modern medicine 2
Unani 3 Homoeopathy 4
Any other, specify: .......................................................................................................................
Spell out the medicines given and results obtained: ......................................................................
399
28. Factors aggravating the disease/chief complaints
Drug 1 Diet 2 Cold Climate 3
Tropical Climate 4 Damp climate 5 Sea shore 6
Positive factors may be spell out: ....................................................................................
29. Factors relieved main complaints
Drug 1 Diet 2 Cold Climate 3
Tropical Climate 4 Damp climate 5 Sea shore 6
Positive factors may be spell out: ....................................................................................
Yes No
30. Past illness, having relation with present illness 1 0
If yes, specify .......................................................................................................................
31. Hypertension 1 0
32. Diabetes mellitus 1 0
33. Bronchial Asthma 1 0
34. Cancer 1 0
35. Cardio vascular disease 1 0
36. Tuberculosis 1 0
Others (specify) ....................................................................................................................
Personal History
37. Diet Veg. 1 Non-Veg 2 Lacto-Ova Veg. 3
38. Sleep Good. 1 Distrubed 2 Insomnia 3
40. Bowel habit Regular 1 Constipation 2 Hard Stool 3
Loose Stool 4
400
41. Dependency Yes 1 No 2
If yes, specify: ......................................................................................................................
42. Prakriti
Vata 1 Pitta 2 Kapha 3
Sannipataja 7
43. Manas Prakriti
Sattva-Rajas 4 Rajas-Tamas 5 Sattva-Tamas 6
Sama 7
If abnormal, specify abnormalities: ........................................................................................
46. Body weight (in Kgs.)
49. Body temperature
50. Pulse
51. Respiration
Present Absent
52. Cynosis 1 0
53. Anaemia 1 0
54. Jaundice 1 0
401
55. Pigmentation 1 0
56. Clubbing of fingers 1 0
57. Deformities 1 0
58. Lymphadenopathy 1 0
If any, specify .......................................................................................................................
Present Absent
59. C.V.S. with chest 1 0
If any, specify .......................................................................................................................
60. C.N.S. 1 0
If any, specify .......................................................................................................................
61. Respiratory system 1 0
If any, specify .......................................................................................................................
62. Digestive system 1 0
If any, specify .......................................................................................................................
63. Uro-Genital system 1 0
If any, specify .......................................................................................................................
Local Examination
Yes No
64. Tenderness on sciatic trunk 1 0
65. Straight leg raising test 1 0
(Sakthi ulkshepa vaishamya) 1 0
66. Defective posture (Dehavakrata) 1 0
402
67. Sensory impairment 1 0
68. Stiffness (Stambha) 1 0
69. Swelling (Sotha) 1 0
70. Muscle wasting (Mamsa sosha) 1 0
Samprapti (Pathogenesis) of the disease according to Ayurvedic Concept
71. Anubandhya dosha – Vata: Vyana 1 Samana 2 Apana 3
72. Anubandha dosha – Kapha: Kledaka kapha 1
73. Dushya: Rasa 1 Mamsa 2 Asthi 3
Snayu 4 Kandara 5
SROTAS PARIKSHA
Mamsa Vaha Srotas: Yes No
74. Arubuda 1 0
75. Alajee (Phlyetenular conjunctivitis) 1 0
76. Ganda mala (Cervical lymphadenitis) 1 0
77. Upajihvika (Epiglotitis) 1 0
78. Adhimamsa (Protuberance of flesh/cancer/cyst) 1 0
79. Putimamsa (decayed flesh/Gangrenous) 1 0
Rasa Vaha Srotas
80. Mukha vairasya (Bad taste in mouth) 1 0
81. Arasyata (Tastelessness) 1 0
82. Hrillasa (Water in mouth) 1 0
83. Gaurava (Feeling of heaviness) 1 0
84. Tandra (Drowsiness) 1 0
403
85. Angamarda (Body ramps) 1 0
86. Jwara (Fever) 1 0
87. Pandu (Anaemia) 1 0
88. Avasada (Depression) 1 0
89. Klavya (Loss of libido) 1 0
90. Karshya (Emaciation) 1 0
91. Agnimandya (Diminished appetite) 1 0
Provisional Diagnosis:
Final Diagnosis:
Medical Management:
Principal Drug Therapy:
Dose —
Vehicle —
Diet —
Summary of findings:
102.Results:
Good Response 1 Fair Response 2

Poor Response 3 No Response 4
Drop out 5 LAMA 6
Death 7
Date: Signature of Investigator

Counter Signature of Head of Deptt.
404
NEW DELHI
PROFORMA
2. Address : ..............................................................................................................................
3. Centre :
5. Patient No.
6. Group No
Parameters to Initially at the 1st 2nd 3rd Follow up

be taken for time of Assessment Assessment Assessment
assessment admission – 15 days – 30 days – 45 days
(1) (2) (3) (4) (5) (6)
Clinical Parameters:
(A). Subjective symptoms
1. Pricking pain
Absent — 0
Mild — 2
Moderate — 4
Severe — 6
405
2. Pulling Pain
Absent — 0
Mild — 2
Moderate — 4
Severe — 6
3. Stiffness
Absent — 0
Mild — 1
Moderate — 2
Severe — 3
(B). Subjective signs:
a. Tenderness of the sciatic nerve
Grade – I (Patient says there is tenderness) — 2
Grade – II (Patient winces) — 4
Grade – III (Winces & withdraws the affected limb) — 6
b. Straight leg raising test (in degrees)
0 — 54
10 — 48
20 — 42
30 — 36
40 — 30
50 — 24
60 — 18
70 — 12
406
80 — 6
90 — 0
c. Ankle jerk
Present — 0
Exaggerated — 1
Absent — 2
d. Knee jerk
Present — 0
Exaggerated — 1
Absent — 2
e. Planter
Present — 0
Up going — 1
Absent — 2
f. Pressing power
a). Upto 10 Kg. — 3
b).10 to 20 Kg. — 2
c). 20 to 25 Kg. — 1
d). 25 and above — 0
g. Muscle wasting
Thigh:
a). Difference of 2.5 – 3.5 cm. — 0.5
b). Difference of 3.5 – 4.5 cm. — 1
c). Above 4.5 cms. — 1.5
407
Calf:
a). Difference of 1 – 1.5 cm. — 0.5
b). Difference of 1.5 – 2 cm. — 1
c). Above 2 cms. — 1.5
Measurement:
25 cm. above the medical mallcolus — R
— L
20 cm. above the knee joint line — R
— L
h. Walking speed (Time taken to cover 20 meters)
a). Upto 20 seconds — 0
b). 21 to 40 seconds — 1
c). 41 to 60 seconds — 2
d). Above 60 seconds — 3
i. Sensory impairment — 2
j. Posture — 8
a). No Complaint — 0
b). Patient can walk without difficulty but experienced — 1

difficulty from getting up form squatting posture
c). Difficulty to squat — 2
d). Difficulty in climbing upstairs — 3
e). Limping gait — 4
f). Can stand on both limbs but with pain — 5
408
g). Can stand without touching the affected limb — 6
on the floor
h). Can sit on bed without support but with pain — 7

and difficulty
i). Lying in bed with pain affected limb flexed by — 8

a supportive pillow
Total numerical value 100
Foot Note: Any abnormalities in Lab. Parameters recorded at the time of admission that may
be considered during the assessment of the progress of the case and also during
follow up period.
Modern Diagnosis
409
NEW DELHI
2. Address : ..............................................................................................................................
3. Centre :
5. Patient No.
6. Group No
Investigations at At the time of After 10 days 20 days 30 days

admission
(1) (2) (3) (4) (5)
Date of sample taken:
Present Absent (P) (A) (P) (A) (P) (A)
7. Sugar 1 0 1 0 1 0 1 0
8. Albumin 1 0 1 0 1 0 1 0
9. Bile Salt 1 0 1 0 1 0 1 0
10. Bile Pigment 1 0 1 0 1 0 1 0
11. Microscopy 1 0 1 0 1 0 1 0
410
Stool:
12. Ova 1 0 1 0 1 0 1 0
13. Cyst. 1 0 1 0 1 0 1 0
14. Occult 1 0 1 0 1 0 1 0
Hematological Investigations:
15. Hb%
16. T.L.C.
17. Polymorph
18. Lymphocyte
19. Basophil
20. Monocyte
21. Eosinophil
22. E.S.R.
Biochemistry:
23. Blood Glucose
24. Urea
25. Serum Cholesterol
(P) (A) (P) (A) (P) (A) (P) (A)
26. VDRL 1 0 1 0 1 0 1 0
27. X-ray spine 1 0 1 0 1 0 1 0

(AP & Lateral view)
28. Pelvis 1 0 1 0 1 0 1 0
If abnormal, specify abnormalities .........................................................................................
411
BLANK
412
CLINICAL EVALUATION OF HERBAL PREPARATIONS
IN THE MANAGEMENT OF MANODVEGA
(ANXIETY NEUROSIS)
Drug : Study Code:

AND SIDDHA
413
BLANK
414
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
I. BACKGROUND
Life is a conglomerate of body (Shareera), faculties (Indriya), mind (Satva), and soul
(Aatma). Any of these cannot be isolated and studied separately. So seers of Ayurveda express
that the term ‘Shareera’ refers body including five senses and mind.
As mind is a dual faculty (Ubhayendriya) or sensory-motor faculty (J’nana-Karmendriya),
it perceives and responds. Even the physical well being is reflected in mind, so is the illness. This
made the terms happiness (Sukha), and misery (Dukha), synonyms of health and illness. The
influence of mind cannot be ruled out in origin, existence or cure of any condition of any disease.
When allowed to persist for long time the psychic and somatic disorders get combined with each
other.
Chittodwega/ Manodwega is one of the Manasika Vikara mentioned in Ayurvedic
literature. The symptoms of this disease can be assumed mostly similar with the generalized
anxiety disorder (GAD). GAD is a disorder requires the presence of unrealistic or excessive
anxiety and worry, accompanied by symptoms from three of four categories: (1) motor tension, (2)
autonomic hyperactivity, (3) vigilance and scanning, and (4) apprehensive expectation. The anxious
mood must continue for at least a month.
The Ayurvedic principle of synthesis of mind, body and soul to consider man as integrated
whole one, would help to treat mental disorders effectively. Medhya rasayanas and Satvavajaya
chikitsa are such a measures, which can be utilized for the treatment of Chittodwega/
Manodwega1.
In Chittodwega/ Manodwega2, when the mind is afflicted with anxiety, fear, agitation etc.
this leads to worry, apprehension, depression, psychological arousal as anger, irritability and
ultimately lead to disturbance in personal, familial and social harmony.
References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chaukhambha Sanskrit
Sansthan, 5th edition, Varanasi, 2001
2. Sushruta Samhita with Nibandha Sangraha commentary of Dalhana and Nyayachandrika
commentary of Gayadasa, Chaukhambha Orientalia Varanasi, 6th edition, 1997.
3. Harrison: Principals of Internal Medicine Vol. II, 13th edition (International edition).
415
Anxiety disorders3 are among the most prevalent psychiatric condition in the world.
Further, studies have persistently shown that they produce inordinate morbidity, utilization of health
care services, and functional impairment. Recent studies also suggest that chronic anxiety disorder
may increase the rate of cardiovascular-related mortality. Hence, clinicians in psychiatry and other
specialties must make the proper anxiety disorder diagnosis rapidly and initiate treatment.
Ayurveda provides rational means for the treatment of many disorders, which are
considered to be obstinate and incurable in other systems of medicine.
II. OBJECTIVES
To evaluate the anti-anxiety effect of an ayurvedic compound drug in patients suffering with
manodwega.
To evaluate efficacy & safety of ayurvedic compound drug in manodwega patients
The efficacy of ayurvedic compound drug for six weeks have been studied on manodwega
in terms of relieving from the symptoms pridictable through ayurvedic clinical parameters &
hamilton’s rating scale for anxiety neurosis.
III. CENTRES
Sample Size : 24 patients in each group (2 groups).
Trial period : 45 Days
Design of the study : Sequential crossover design and double blind method are
adopted.
Drug & dosage : The Ayurvedic compound consists of Mandukaparni
(Centella asiatica), Yasti (Glycyrrhiza glabra), Jatamamsi
(Nardostachys jatamansi) in the ratio of suspended in the
Kshirabala Thaila. The daily dose of Ayurvedic drug is
3gms. / Day in 3 divided doses. Each capsule contains
500mgs of drug i.e.Mandukaparni (120mg), Yasti (120mg.)
Jatamamsi (240mg.) and ksheerabala taila (3 drops).
The daily dosage of diazepam is 15mg. /day also in three
divided doses. The placebo is plain starch powder.
Duration of the study : 45 days drug therapy with a follow up for 7 days.
416
Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 7 days of treatment.
1. Age between 16-45 years of either sex
2. Presence of cardinal features of manodwega
3. Onset between 8weeks to 2 years
4. Ambulatory and co-operative
1. Age below 16 yrs. and above 45 yrs.
2. Duration of the disease – below 8weeks and above 2years.
3. Exhibiting psychotic symptoms
4. Factors interfering with concentration and communication
5. Hypertension
6. Diabetes
7. Any other systemic diseases
1. If patient does not follows the instructions.
2. Any complication developed during the course of trial.
A detailed clinical and social history is taken. The patients assessed on the basis of clinical
parameters and Hamilton’s anxiety rating scales.
IX. METHOD OF ASSESSMENT OF TREATMENT
1. Clinical Symptomatic Relief
2. Psychological parameters
3. Hamilton’s anxiety rating scale
417
mail.
analysis.
screening, 8th day, 15th day and so on upto 45th day (weekly once).
418
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Clinical evaluation of herbal preparations in the management of
Manodvega (Anxiety Neurosis)”.

Relationship ___________________________________
419

Chittodwega/ Manodwega is one of the Manasika Vikara mentioned in Ayurvedic
literature. The symptoms of this disease can be assumed mostly similar with the generalized
anxiety disorder (GAD). GAD is a disorder requires the presence of unrealistic or excessive
anxiety and worry, accompanied by symptoms from three of four categories: (1) motor tension, (2)
autonomic hyperactivity, (3) vigilance and scanning, and (4) apprehensive expectation. The anxious
mood must continue for at least a month.
The Ayurvedic principle of synthesis of mind, body and soul to consider man as integrated
whole one, would help to treat mental disorders effectively. Medhya rasayanas and Satvavajaya
chikitsa are such a measures, which can be utilized for the treatment of Chittodwega/Manodwega.
In Chittodwega/ Manodwega, when the mind is afflicted with anxiety, fear, agitation etc. this
leads to worry, apprehension, depression, psychological arousal as anger, irritability and ultimately
lead to disturbance in personal, familial and social harmony.
Anxiety disorders are among the most prevalent psychiatric condition in the world. Further,
studies have persistently shown that they produce inordinate morbidity, utilization of health care
services, and functional impairment. Recent studies also suggest that chronic anxiety disorder may
increase the rate of cardiovascular-related mortality. Hence, clinicians in psychiatry and other
specialties must make the proper anxiety disorder diagnosis rapidly and initiate treatment.
Ayurveda provides rational means for the treatment of many disorders, which are
considered to be obstinate and incurable in other systems of medicine.
instructions scrupulously. The study will take approximately 45 days.
420
421
CASE REPORT FORM – I SCREENING
BEFORE TREATMENT
1. Name of the patient: .................................................... Age: ................. Sex: ...................
2. Address: ...............................................................................................................................
3. Centre:
5. Patient No.
6. Group No
Yes (1) No (0)
2. Cardinal features of udvega present
3. Onset between 8 weeks and 2 years
4. Ambulatory and co-operative
5. Hypertension
6. Diabetes
7. Any other systemic disease
9. Duration of illness less than 1 month and more

than 2 years
422
10. Exhibiting psychotic symptoms
11. Factors interfering with concentration and

communication
423
CASE REPORT FORM – II ADMISSION
1. Name of the patient : ...........................................................................................................
2. Address : ..............................................................................................................................
4. Patient No.
6. Centre :
8. Age of Patient (in years)
9. Group No.
12. Total income of the family (in Rs.) ...........................................................
424
Chief Complaints with duration (in days) : Yes (1) No (0)
15. Free floating anxiety
16. Fear
17. Vague aches and pains
18. Panic attacks
19. Difficulty in concentration
20. Psychosomatic symptoms (tick if present)
Depersonalisation
Tremors and tics ____________
Profuse sweating ____________
Dryness of mouth ____________
Throat choking ____________
Chest constriction ____________
Palpitation ____________
(Organicity must be ruled out)
23. Treatment given so far: Ayurvedic medicine 1 Modern medicine 2
Unani 3 Homoeopathy 4
Siddha 5 Mixed 6
24. Factors aggravating the disease / chief complaints

_______________________________________________________________________
425
25. Factors relieving main complaints
_______________________________________________________________________
26. History of past illness, having relation with present illness. Yes 1 No 0
If yes, specify _________________________
27. History of previous episodes. Yes 1 No 0
If yes, specify _________________________
Family History, if any Yes (1) No (0)
28. Mental retardation
29. Mental disease
30. Anxiety neurosis
Personal History
31. Diet Veg Non-veg Lacto-ova veg
32. Sleep Good Disturbed Insomnia
34. Bowel habit Regular 1 Constipation 2 Loose 3
35. Addiction Yes 1 No 2
If yes, Specify _______________________________________
36. PRAKRITI :
Vata-kaphaj 4 Vata Pittaj 5 Pitta- Kaphaj 6
Sannipataj 7
426
37. MANAS PRAKRITI :
Sattva Rajas 4 Sattva- Tamas 5 Rajas-Tamas 6
Sama 7
Physical examination
38. Build Lean 1 Medium 2 Heavy 3
40. Body weight (Kg)
42. Blood pressure (diastolic)
43. Body temperature
44. Pulse
45. Respiration
46. Cyanosis
47. Anaemia
48. Jaundice
49. Clubbing of fingers
50. Deformities
51. Lymphadenopathy
Systematic examination Normal Abnormal
52. C.V.S. with chest 0 1
If abnormal, specify abnormalities ____________________________________________
427
53. CNS 0 1
54. Digestive system 0 1
55. Uro-genital system 0 1
Samprapti (Pathogenesis) of the disease according to Ayurvedic concept.
56. Anubandhya Shareerikadosha Vata 1 Pitta 2 Kapha 3
57. Anubandhashareerika Vata 1 Pitta 2 Kapha 3
58. Anubandhya-manasikadosha Rajas 1 Tamas 2
59. Anubandhya-manasikadosha Rajas 1 Tamas 2
60. Ksheena shareerikadosha Vata 1 Pitta 2 Kapha 3
61. Ksheena manasikadosha Rajas 1 Tamas 2
62. Ksheena dhatu (indicate) Rasa 1 Rakta 2 Mamsa 3
Meda 4 Asthi 5 Majja 6
Shkra or Artava 7 Oja 8
63. Dooshya Rasa 1 Rakta 2 Mamsa 3
Meda 4 Asthi 5 Majja 6
Shkra or Artava 7
64. Stages of disease : Sanchaya 1 Prakopa 2 Prasara 3
Sthanasamsraya 4 Vyakti 5
Bheda 6
428
Srotas Pareeksha
65. Pran vaha srota
Abhikshana Swasa (Chyne stroke breathing) 3
Kupit Swasa (Vitiated breathing) 4
66. Udakavaha srota
Talu sosha (Dryness of palate) 3
Kantha sosha (Dryness of throat) 4
Kloma sosha (Excessive thirst) 5
Trishna (Thirst) 6
67. Annavaha srota
Aruchi (Anorexia) 2
Hrillasa (Water brash) 3
429
Tandra (Stupor) 5
Jwara (Fever) 7
Pandu (Anaemia) 8
Avsada (Depression) 9
Klibya (Loss of libibo) 10
Pidika (Boils) 1
Mukha Pak (Stomatitis) 3
Charma roga (Skin disease) 5
Kamala (Jaundice) 6
Arubud (Tumour) 1
Aljee (Phlyctenular conjunctivitis) 2
Gandamalaa (cervical lymphadenitis) 3
Upji (Epiglotis) 4
430
Maladhikya (Excess of excreta) 1
Tandra (Stupor) 4
Dehachikkanta (Greasiness of the skin) 5
Alasya (Lethargy) 6
Adhyasthi (Hypertrophy of bone) 1
Dantshoola (Toothache) 3
Asthi shoola (Bone pain) 4
Kesha, loma, nakha, samshru vikara 5

73. Majja_vaha srotas
Moorchh (Syncope) 3
74. Shukra_vaha srotas
Klaivya (Sterility / impotence) 1
Santam Vikriti (Congenital deformity of the children) 4
431
75. Manovaha srotas
Manovibramsha 1
Budhivibramsha 2
Sanjna Vibhramsha 3
Smritivibhramsha 4
Bhaktivibhramsha 5
Sheelavibhramsha 6
Chesta Vibhramsha 7
Acharavibhramsha 8
77. Vandhyatva (Sterility) 2
Bahumutra (Polyuria) 1
Atibadhata (Urination with obstruction) 2
Prakop-mutra (Defective Urination / Difficulty 3

in micturition)
Aabhikshna (Constant / repeated urination) 5
Bahulamutrata (Urine with prostatic secretion) 6
Sashool amutrata (Painful micturition) 7
Alpaalpa Pureesha (Scanty defecation) 1
Sashoola Pureesha (Painful defecation) 2
432
Atidrava Pureesha (Diarrhoea) 3
Atigrathita yukta Pureesha (Scybala) 4
Aswedan (Loss of perspiration) 1
Aangaparidaha (Burning sensation in the body) 5
81. Investigations
82. Provisional Diagnosis Final Diagnosis
83. Medical management
84. Principle drug therapy
Drug Dose Vehicle
Diet
85. Duration of treatment
86. Summary of findings
87. Results : Good response 1 Fair response 2
Poor response 3 No response 4
Drop-out 5 LAMA 6
Death 7
Date : Signature of Investigator
433
CASE REPORT FORM - III INVESTIGATIONS
Name : ...............................................................................................................................................
Age : ............................... Sex : .................. Date: ......................................................
Investigations Before starting After 45 days
treatment
URINE (24 hour sample)
1. 17 – hydroxyl-cortico steroids
2. 17- keto-steroids
3. Vanillyl mandelic acid (VMA)
4. Routine
HAEMATOLOGICAL INVESTIGATIONS :
5. Hb _________________ gm/dl
6. T.L.C. (in thousand/Cmm)
D.L.C
7. Polymorphs ________________ %
8. Lymphocyte ________________ %
9. Basophil ________________ %
10. Monocyte ________________ %
11. Eosinophill ________________ %
12. E.S.R. 1 hr ________________ mm
2 hr ________________ mm
BIOCHEMISTRY :
13. Blood Glucose (Random) _____________ mg/dl
14. Urea _____________ mg/dl
15. Blood lactic acid estimation if possible
16. S. Creatinine _____________ mg/ dl
17. ECG
434
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE MANAGEMENT OF
MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – IV PERIODICAL OBSERVATION & ASSESSMENT
Centre : ...................................................................... Date: ......................................................................................
Code No: ................................................................... Sr. No. of the subject: ...........................................................
Subject‘s Name: ......................................................... Sex: .................................................. Age: ...........................
Parameters Initial At the end of 45 days

Clinical Parameters
435
a. Subjective symptoms
1. Hamilton’s anxiety rating scale
2. Taylor’s manifest anxiety scale
b. Objective test
1. Work output (cancellation of 9s)
2. Perceptual discrimination
(Closing the Cs into Os)
3. Psychomotor performance tests
a. Hand precision (Finger dexterity test)
b. Hand steadiness (Steadiness tester)
c. Speed of response (Tapping board)
Blank
436
METABOLIC DISORDERS
SECTION - VI
Blank
438
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND
PLACLINICAL TRIAL OF VYOSHADI GUGGULU IN
THE MANAGEMENT OF OBESITY (MEDOROGA)
Drug : Study Code:

AND SIDDHA
439
Blank
440
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
I. BACKGROUND
Obesity (Medoroga) is a condition in which there is an excessive accumulation of fat in the
body. Framingham study showed that a 20% excess over the desirable body weight clearly
poses risk to health. This disease is a metabolic disease generally occurs in affluent societies. It is
associated with increased mortality by predisposing to the development of important diseases like
diabetes, hypertension, atherosclerosis, heart disease, arthritis, infertility etc. and diminishes the
efficiency and happiness of those affected.
Because of imbalance between energy intake and expenditure, the excess fat accumulates
in the body. Although no satisfactory etiological classification of obesity is well defined but number
of factors are known to be associated with its development. Obesity is most prevalent in middle
age, but it can occur at any stage of life. It is prevalent in high socio-economic group. There are
certain professions in which obesity is common. Familial tendency exists in many cases.
Endocrine factors and energy imbalance are also responsible for the obesity. There are certain
drugs which cause obesity like steroids, oral contraceptives, phenothiazine, insulin etc.
The following complications generally occur in this disease viz. - psychological and sexual
problems, mechanical disabilities, osteoarthrosis of knee, hip, lumbar spines, abdominal and
diaphragmatic hernias and varicose veins, exertion dyspnoea, metabolic disorders like non-insulin
dependent, diabetes mellitus (NIDDM), hyperlipidaemia, gall stones, hyperuricaemia and
cardiovascular disorders. Low cardia output increases susceptibility to hypertension and IHD.
The current line of management in modern medicine is not giving satisfactory response in
the treatment of obesity. At this juncture it becomes essential to explore the efficacy of certain
Ayurvedic drugs in the management of obesity. Guggulu is one of major ingredient of the trial drug
of this project, on which many scientific research studies, (experimental and clinical both) have
been conducted establishing its hypocholestraemic, anti-obesity and anti-atherosclerotic effect.
II. OBJECTIVE
The aim of the present study is to assess the efficacy of Vyoshadi guggul in the
management of obesity.
III. CENTRES
CCRAS identified centers.
441
No. of Groups — Two
No. of patients in each group — 60
Sample Size — 120 (60 subjects in each group)
Drug — Vyoshadi Guggulu
Dosage — 1gram (2 capsules of 500 mg. each)
two times a day.
Duration — 6 months
Design of the study — Randomised Double blind placebo
controlled study.
Duration of the study — 6 months drug therapy with a
follow up for 3 months without
drug.
Total period of study — 9 months
1. Age above 25 years and below 60 years of either sex
2. Presence of obesity, i.e., weight is more than 20 % excess of the desirable weight
according to height, sex and age(according to annexed height and body weight table) Or
Age adjusted BMI above 85th percentile (Indian standard)
3. WHR i.e., Waist Hip Circumference ratio >0.95 in males and >0.8 in females
1 Age below 25 years and above 60 years
2. Obesity secondary to or associated with Hypothyroidism, hypertension, Diabetes mellitus,
hyperlipidemia or Cushing’s syndrome.
3. Any concomitant serious disorder of the liver, kidneys, heart, lungs or other organs.
4. Pregnancy and Lactation.
5. Person undergoing treatment for any other serious illness.
442
During the course of the trial, if any serious complication develops which requires urgent
treatment with other drugs and therapies, such subjects may be withdrawn from the trial. The
Investigator shall mention the probable cause of withdrawal.
the Case Record Form (Forms I & IA). Clinical assessment will be done before drug
administration (0), at the end of 1st month, 3rd month and 6th month during treatment and at the
end of 9th month follow up (Form II). The laboratory investigations will be recorded before
drug administration, at the end of three month, at the end of treatment (6 months) and at the end
of follow-up.(9th month) [Form III] .
IX. FOLLOW UP
Follow-up will be carried out for 3 months after completion of treatment.
methods.
XI. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by EC. Both will be maintained in duplicate with one
copy given to the patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of
study and put in a place where by prompt reporting of adverse events occur. The data will
be reviewed as every 20 participants entered the study and administered the trial drugs.
The research team will report immediately to the PI and Data Monitoring Board if, any
life threatening conditions whether they are perceived to be study related or not. The
Board decides whether the adverse effects warrant discontinuation of the study protocol.
Protocols will be written and approved for the treatment of study related adverse events.
443
uniformity.
444
(MEDOROGA)
the patient.
Date: _______________ Signature of the investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
in the, “Multicentric double blind pre-clinical trial of vyoshadi guggulu in the management of obesity
(medoroga).

Relationship ___________________________________
445
(MEDOROGA)

Ayurveda has a very comprehensive approach for the management of Obesity. The present
study aims at evaluating selected Ayurvedic formulation for its efficacy in Obesity. You are invited
to participate in this study where you will be provided with a combination of Vyoshadi gugulu in
the dose of 1 gm. (2 capsules of 500mgms each) two times a day. There have been earlier trials
too showing the efficacy of similar formulation. About 360 persons with Obesity shall be included
in this trial for which 3 big hospitals from different parts of the country are participating in the trial.
instructions scrupulously. The study will take approximately 9 months to complete(6months of
medication and thereafter 3 months of follow up). During this period, you are expected to visit the
hospital five times. Six visits shall have to be undertaken one initially when you are included in the
trial, then after one month, after 2 months, after 4th month, after 6th month and after 9th month.
If you are found eligible, you would be put on trial treatment for 6 months. The daily
dosage will be 500 mg twice daily. At each visit, you will be supplied with sufficient quantities of
drugs to last until your next visit.
446
(MEDOROGA)
1. Centre: ______________________________
2. Name of the subject: ______________________________________________________
3. Address : _______________________________________________________________
4. Centre: ______________________________
CRITERIA OF SELECTION Yes (1) No (2)
1. Age between 25-60 years
2. WHR i.e., Waist Hip Circumference ratio >0.95 in males

and >0.8 in females
3. Presence of obesity, i.e., weight is more than 20 %

excess of the desirable weight (according to annexed
height and body weight table)
Or
Age adjusted BMI above 85th percentile (Indian standard)
5. Endocrine disorders
447
7. Hyper-tension
8. Pregnancy and Lactation
9. Malignancy
10. Athletes or body builders having muscular hypertrophy
11. Cardiac illness
If admitted, Subject’s Serial No. ____________
No. of packets issued: _____________________
Date: ____________ Signature of the Investigator: ________________
448
(MEDOROGA)
CASE REPORT FORM IA – HISTORY
1. Centre: ______________________________
2. Sr. No. of the subject: ____________________________________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
10. Occupation Desk work 1 Field work 2
12. Income per capita per month (in Rs.) :
449
Chief complaint with duration (if any) in days
Absent (0) Present (1) Duration
13. Polyphagia
14. Polydipsia
15. Excess sweating
16. Excess sleep
17. Body fatigue
18. Loss of libido
19. Palpitation/dyspnoea on exertion
Personal History
20. Diet Veg. 1 Non-veg. 2
21. Sleep Good 1 Disturbed 2 Insomnia 3
22. Emotional stress: No 0 Yes 1
23. Bowel habit: Regular 1 Irregular 2
24. Prakriti: Vataja 1 Pittaja 2 Kaphaja 2
Vata-kaphaja 2 Vatapittaja 2 Pitta-Kaphaja 2
Sannipataja 2
25. Addiction No 0 Yes 1
If yes, Specify__________________________________________
26. Built: Lean 1 Medium 2 Heavy 3
28. Body weight (Kg.) _________________________
450
29. Body height (in cm.) _________________________
30. Skin fold thickness(Triceps) _________________________
31. Blood pressure (Systolic) _________________________
32. Blood pressure (Diastolic) _________________________
33. Pulse _________________________
34. Respiration _________________________
35. Cyanosis
36. Anaemia
37. Jaundice
38. Lymphadenopathy
SYSTEMIC EXAMINATION Absent (0) Present (1)
39. C.V.S. (with Chest)
If abnormal, specify abnormalities_________________________________
40. C.N.S.
If abnormal, specify abnormalities_________________________________
If abnormal, specify abnormalities___________________________________
43. Respiratory System
451
Samprapti (pathogenesis) of the disease according to Ayurvedic concept
44. Dosa Vata Pitta Kapha
Anubandhya dosha
Anubandh dosha
Avaraka dosha
Ksheen dosha
45. Dushya (Involved): Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Ojas
Srotas Pariksha
Tandra (Stupor) 4
Alasya (Lethargy) 6
47. Garbhapata (Abortion) Absent (0) Present (1)
48. Santana vikriti Absent (0) Present (1)

(Congenital deformity in the children)
452
(MEDOROGA)
CASE REPORT FORM II – CLINICAL AND ANTHROPOMATRIC ASSESSMENT
(0, 1, 3, 6, 9th months)
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
10. Polyphagia
11. Polydipsia
12. Excess sweating
13. Excess sleep
14. Body fatigue
15. Loss of libido
16. Palpitation/dyspnoea on exertion
453
Anthropometric assessment
17. Body weight (Kg.) _________________________
18. Skin fold thickness(Triceps) _________________________
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
454
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF VYOSHADI
GUGGULU IN THE MANAGEMENT OF OBESITY (MEDOROGA)
(0, 3rd , 6th AND 9th MONTH)
FORM III – LABORATORY INVESTIGATIONS
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
Routine ____________ Microscopic____________
Ova/Cyst ___________ Occult Blood____________
12. TC (Cells/Cmm.)_____________________
13. DC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) ________
14. Hb (g/dl) _________
15. ESR (1st hour mm) __________
455
16. PCV (%) _______________
17. Blood Sugar – PP (mg./dl) _______________
18. S. Cholesterol (mg./dl) _______________
19. HDL(mg./dl) _______________
20. LDL (mg./dl) _______________
22. B. Urea (mg./dl) _______________
24. Uric acid (mg./dl) _______________
26. Albumin (gm./dl) _______________
27. Globulin (gm./dl) _______________
28. A/G Ratio _______________
29. Acid Phosphates (KA units) _______________
30. Alk. Phosphates (KA units) _______________
31. E.C.G: [ 0 Month only]
32. X-ray Chest: [ 0 Month only ] _____________________________________________
33. T3: _________ T4 : __________ TSH: ___________
34. Any other Remarks _____________________________________________
Date: _____________ Signature of the Investigator: ______________________
456
RANDOMISED DOUBLE BLIND CONTROLLED
CLINICAL TRIAL OF AYUSH-DIAB IN CONTROLLING
BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
Drug : Study Code:

AND SIDDHA
457
Blank
458
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
I. BACKGROUND
Diabetes is a metabolic disorder; a comparable condition of Madhumeha specifically an
abnormality in the way of the body utilizes glucose, due to an absolute or relative deficiency of the
hormone insulin or resistance by the body tissues to the action of insulin.
Conventional modern medicine provides a number of drug of choice for controlling the
blood sugar level in the patients of diabetes mellitus type-2. However, with the prolonged
treatment doses of the drugs often needs to be increased to control the blood sugar level and a
time comes when patient has to be switched over to insulin. Such patients become cases of insulin
dependent diabetes mellitus. With a view to help the suffering community there is a need to find a
safer drug, which can be used to control the blood sugar level and such drug can be used safety
for longer periods.Ayurvedic classics provide references on herbal and herbo-mineral preparations
which can be safely used in controlling the blood sugar level in the patients of diabetes mellitus.1
II. OBJECTIVE
To study the effect of Ayurvedic formulation in controlling blood sugar level of the patients
suffering with Type-2 Diabetes mellitus.
III. CENTRE
Identified Centres of CCRAS
References
1. Harrison’s Principle of Internal Medicine 15th Edition Page 2109-2135.
2. The Expert Committee on the Diagnosis and classification of Diabetes Mellitus : Report of the
Expert Committee on Diagnosis Classification of Diabetes Mellitus, Diabetic care 1997;
207:1183-97.
3. Siddharth N Shah, Asshit Shah, API Text Book of Medicine 5th Edition Page-1460.
4. Vaisajya Ratnawali, Saptam Sanskaran 2040 Page 812.
459
Sample Size-100
Total Number of group-Two
Total number of patients in each group-50
Level of study-OPD
Treatment:
A. Dietary regimen: Patient will be advised to restrict their dietary schedule and do
light exercises (like brisk walking for two kms. per day, swimming, jogging etc.
during treatment).
B. Trial drug:
1. Ayush-DIAB 500 mg dragees BD with water half hrs before meals (Capsule
Ayush-DIAB contained extracts of Meshashringi (leaves) one part+ Amra Beeja
Majja one part + Karvelaka Beeja one part + Jambu Beeja one part + Silajeeta
one part) for six months.
Diet: - Patients will be advised to take their diet as described in Patient information sheet
and do brisk walking/jogging or light exercise for half hour daily..
2. Standard control: Glimepiride 1mg OD ½ hour before meal.
Duration of the study: Six months (total duration of the study 2 years)
Duration of medication - Six months
Total duration of study – 2 years
2. If yes in any of the three
Blood sugar – Fasting > 126 and =< 200 mg/dl or
PP > 200 mg/dl and <= 350 mg/dl or
Glycated haemoglobin > 7% and <10%
3. Recently diagnosed (< 6 Month) cases of Type-2 Diabetes mellitus not taking any anti
Diabetic drug.
460
If yes in any of the three
Blood sugar – Fasting =< 126 and > than 200 mg/dl or
PP=< 200 mg/dl >350 mg/dl or
Glycated haemoglobin<=7% and =>10%
2. Malignant and accelerated hypertensive
3. CVS disorder (CAD)
4. Pregnant woman and planning to be pregnant within six months
5. Lactating mother
6. Secondary Diabetes mellitus
7. Patient under going regular treatment for Diabetes or any other severe illness
8. CNS disorder e.g. encephalopathy
The investigator shall withdraw the patients from the study if
1. Fasting blood sugar rises to >200 mg. /dl. Or post prandial blood sugar level increases
to>350 mg./dl and are not controllable within fifteen days.
2. Any serious complication develops which requires urgent treatment with any other drug/
therapy?
The investigator will mention the probable cause of withdrawal and provide possible
medical treatment to manage the illness.
proformae (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations will be recorded before drug
administration, after every two weeks (blood Sugar only) and at the end of treatment (Form-III)
If during treatment or after treatment fasting Blood sugar becomes<126 mg. /dl. and post
prandial Blood sugar< 200mg./dl. and HbA1c < 7% it will be treated as successful outcome of
the treatment.
461
Data on Fasting/Post prandial blood sugar and HbA1c will be analyzed using appropriate
statistical methods.
The progress of the trial will be monitored by CCRAS Hqrs. New Delhi consisting of one
expert each of allopathy and Ayurveda besides one outside expert. Data analysis will be
undertaken at the Monitoring Unit CCRAS Hqrs. New Delhi
XII. ETHICAL REVIEW
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
uniformity.
462
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS
CONSENT FORM
the patient.
Date: _______________ Signature of the Investigator: ___________
Name of Investigator: ________________
CONSENT BY SUBJECT
in the clinical trial on Randomized Controlled Clinical Trial of Ayush-DIAB Capsules in the
Controlling Blood Sugar Level in Type 2 Diabetes mellitus.

Relationship ___________________________________
463
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS

Research is going on to find a suitable natural product for the treatment of Type-2
Diabetes mellitus. You are invited to participate in such a study in which you will receive either
Ayurvedic trial drugs or control drug for 24 weeks.
The aim of the present study is to assess the anti-diabetic effect of these drugs in the
management of Type 2 Diabetes mellitus patients.
Total 100 patients from this and other hospitals will be taking part in this study.
instructions scrupulously. The study will take approximately six months to complete. After this
period, you are expected to visit the hospital every fortnight. The interval between the first and
second visit will be around 15 days.
physical examination. ECG, Blood and urine samples will also be taken. This is to make sure that
One week later, at your second visit, if you are eligible, you would be put on trial treatment
for 24 weeks. You may receive either trial drug or control drug for 24 weeks. You should follow
life style modifications (Diets Advice, Exercise) as given along with information Sheet.
From the first visit onwards, you will be required to fast overnight before attending each
visit. Blood and urine samples will be taken at every visit. At each visit, you will be supplied with
sufficient quantity of drug to last until your next visit.
What happens at the end of the study?
The trial treatment will be stopped at the end of 24 weeks. You will be put back on an
appropriate treatment available in the market.
464
Are there any risks?
Both trial and control drugs may cause hypoglycemia (very low blood sugar) in some
cases. The symptoms of hypoglycemia are sweating, drowsiness, nausea, confusion and in-
coordination. In case of such symptoms, you should immediately take sugar, glucose/biscuits and
milk/fresh lime juice/orange juice with sugar and report to the doctor.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment to control
your blood sugar?
When you leave can the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
DIET REGIMEN:
To take 25 cal/kg per day (Moderate work)
Protein 0.8 gm/kg per day
Total Fat < 30% of calories (Saturated fat < 10% polyunsaturated fat < 10% of calories)
Cholesterol < 300 mg per day
Dietary fibre 50 gm per day (atleast)
Common salt < 5 gm. per day
465
Saturated fat & cholesterol are found in e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil.
These contain highly saturated fat. Patient should be advised to take less saturated fat and
cholesterol.
Poly unsaturated fat take Sun flower oil, Soyabene oil, Olive oil which contained
unsaturated fat should be taken 3 small tea spoonful / day.
Milk : Three cup daily double tone
Whole Cereal: 90 gm daily. [old samarice, kodo, java, wheat with husk]
Vegetable : 250 gm daily [padwal, karaila, methi, pumpkin, brinjal, beans]
Dal : 400 ml. daily [Moong, Masoor, Kulthi, Arhar, Garam]
Fruits : 200 gm. Daily [Apple,Guava & Pappaya]
Spices : [Ginger,coriander,cardamom]
DO’NT
To avoid smoking.
To avoid Fasting.
To avoid sweets, honey, sugar, jaggery, cold drinks, fruit juice, avoids fruits e.g. Mango,
Sharifa, Grapes, Chiku, Banana, Khajur, potato,turnip & beetroot
466
MELLITUS
1. Centre: ______________________________
3. Sr. No. of the Subject : ____________________________________________________
4. Address : _______________________________________________________________
Blood sugar – Fasting > 26 and =< 200 mg/dl or
PP > 200 mg/dl and<= 350 mg/dl or
Glycated haemoglobin>7% and <10%
3. Recently diagnosed (< 6 Months)
Cases of Type-2 Diabetes mellitus
Not taking any hypoglycemic drug or insulin.
CRITERIA FOR EXCLUSION Yes (1) No (0))
467
Blood sugar – Fasting =< 126 and > than 200 or
PP=< 200 mg/dl >350 mg/dl or
Glycated haemoglobin<=7% and =>10%
6. Malignant and accelerated hypertensive
7. CVS disorder (CAD)
8. Pregnant woman or the women planning to be pregnant

in next six months
9. Lactating mothers
10. Secondary Diabetes mellitus
11. Patient under going regular treatment for Diabetes or

for any other severe illness
12. CNS disorder e.g. encephalopathy
A patient is eligible for admission
If ‘Yes’ to S.No.1 – 3 & ‘No’ to 4 – 12
If admitted:
Sl. No. of the subject ____________
No. of packets issued____________
Date:____________ Signature of the Investigator _____________
468
MELLITUS
1. Centre: ______________________________
5. Address : _______________________________________________________________
12. Religion : Hindu 1 Muslim 2 Sikh 3
Christian 4 Parsi 5
469
13. Polyuria (Excessive Urine)
14. Polyphagia (Excessive Hunger)
15. Polydipsia (Excessive Thirst)
16. Exhaustion/Tiredness
17. Loss of body weight
18. Body ache
19. Giddiness
20. Polyneuritis(Numbness / Tingling)
21. Visual disturbance
22. Others
If Yes specify: _____________________________________
Personal History
23. Diet Veg. 1 Non-veg. 2 Lecto-veg 3
24. Presence of anxiety No 0 Yes 1
25. Constipation No 0 Yes 1
Addiction
If yes specify: (a) Quantity [packs]: ________________
(b) Total Duration in year’s ________________
If yes specify: (a) Quantity: ________________
470
If yes specify: (a) Quantity (in ml/day): ________________
29. Any other(specify) _____________________
30. Prakriti: Vata 1 Pitta 2 Kapha 3
Vata-kaphaj 4 Vata-pittaja 5 Pitta-Kaphaja 6
Sannipataj 7
31. Height (cm) ____________
32. Weight (kg) ____________
33. Pulse (per min) ____________
34. Blood Pressure (in sitting position)
Systolic_________________(mm Hg)
Diastolic ________________(mm Hg)
35. Body temperature (o F) _____________
37. Signs of dehydration and oedema, if any____________________
SYSTEMIC EXAMINATION Absent (0) Present (1)
38. CVS
If abnormal, details _______________________________________________________
39. CNS
471
Date: ____________________ Signature of Investigator ___________________
472
MELLITUS
CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT
[Before Treatment & Fortnightly During Treatment]
1. Centre: ______________________________
5. Address : _______________________________________________________________

(in days)
9. Polyuria (Excessive Urine)
10. Polyphagia (Excessive Hunger)
11. Polydipsia (Excessive Thirst)
12. Exhaustion/Tiredness
13. Bodyache
14. Giddiness
15. Polyneuritis (Numbness / Tingling)
473
16. Visual disturbance
17. Others
If Yes, specify: ___________________________________________________________
Physiological Assessment
18. Weight (in Kgs.) ______________
19. Blood Pressure (in sitting position)
Systolic_________________ (mm Hg)
Diastolic ________________ (mm Hg)
474
MELLITUS
CASE REPORT FORM IV- LABORATORY INVESTIGATION
1. Centre: ______________________________
3. Sr. No. of the subject: _____________________________________________________
4. Name of the subject: _______________________________________________________
5. Address : _______________________________________________________________
Urine Examination
Routine
9. Sugar ____________
10. Albumin ____________
11. Deposits ____________
Microscopic
12. Pus cell ____________(hpf)
13. RBC ____________(hpf)
14. Cast ____________(hpf)
Stool examination
15. Routine ____________
475
Microscopic
16. Ova ____________
17. Cyst ____________
18. Occult Blood__________
Blood
19. TC (Cells/Cmm.): ____________
20. DC: P(%)_____ L(%)_____ E(%)_____ M(%)_____ B(%)_____
21. Hb (g/dl) ____________
22. (1st hour.) ____________
23. Blood Sugar- Fasting/PP (mg./dl)____________/____________
24. Glycosylated) HbA1c (to be done before treatment

after three months and end of treatment)
25. Blood Urea (mg. /dl) ____________
26. S.Creatinine (mg./dl) ____________
27. Uric acid (mg./dl) ____________
LIPID PROFILE
28. Serum total Cholesterol (mg./dl) ____________
29. S. Triglycerides (mg./dl) ____________
30. HDL (mg./dl) ____________
31. LDL (mg./dl) ____________
32. VLDL (mg/dl) ____________
LIVER FUNCTION TEST
Serum Bilirubin
33. Total (mg/dl) ____________
476
34. Direct (mg/dl) ____________
35. SGOT (IU/L) ____________
36. SGPT (IU/L) ____________
37. Alk.Phosphatase (KA units) ____________
38. Total proteins (gm./dl) ____________
39. Albumin (gm./dl) ____________
40. Globulin (gm./dl) ____________
41. A/G Ratio ____________
Serum Electrolytes
42. Sodium(mEq/L) ____________
43. Potasium(mEq/L) ____________
Sl.No.9 – 43 will be done before and after treatment except Sl.No. 23 (Blood Sugar) which
will be done before treatment and fortnightly during treatment period. HbA1c will be repeated
after three months also.
Date: ______________ Signature of Investigator__________________________
477
Blank
478
EYE DISORDERS
SECTION - VII
Blank
480
CLINICAL EVALUATION OF AYUSH-CT DROPS AND
AYUSH-CT CAPSULE IN IMPROVING THE QUALITY
OF VISION AND PREVENTION OF PROGRESS IN
SENILE IMMATURE CATARACT (LINGANASA)
Drug : Study Code:

AND SIDDHA
481
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482
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
I. BACKGROUND
Senile cataract (Linganasa1) is a disease of common occurrence in all geographical areas
and in all races. The incidence, however, is distinctly more in tropical countries. The two factors
peculiar to tropical circumstances and responsible for this high incidence are higher concentration
of actinic rays in tropical sunlight, and the nutritional deficiency factors so significant in these areas.
It can be generally stated that in developing tropical countries, the age of 50 years and above is
considered a cataractogenous age and the degree of incidence increases as the age advances. It
is safe to assume that 60% people develop cataract by the age of 60 years. 70% by the age of
70 years, 80% by 80 years and 90% by 90 years of age. It was estimated that 55% of total or
partial blindness was due to cataract in some stage of its formation. Of these, the incidence in
rural areas was 70% and in Urban areas 30%. Similarly, the incidence in males was 64.4% as
compared to 35.6% in females. It is rare in persons under 50 and these disturbances occur in (a)
impaired semi permeability of the capsule, (b) increased insoluble proteins, and (c) less effective
auto-oxidative system.
The current lines of management include various surgical methods. There is no definite
medical treatment for this condition in the patients where surgical treatment is not suitable (like
uncontrolled diabetes, cardiac disorders and so on.) Ayurvedic literatures have recorded many
single drugs and compound formulations for the treatment of Linganasa/Timira. (Cataract) .Drugs
like Punarnava, Amalaki, Palasha etc. possess various pharmacological actions like Chakshushaya
(Improves visual acuity), Timira hara (Effective managing various disorders of vision) besides its
Rasayana action that prevents free radical damage i.e. anti-oxidant effect1.
II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-CT Drops and Ayush-CT Capsule In
improving the quality of vision and Prevention of progress in senile immature cataract
References
1. Ambika Dutta Sashtri (1989) Susruta Samhita (text with Hindi commentary) Uttara Sthana, VIIth
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi
483
III. CENTRE
Sample size : 50 cases
1. Ayush-CT Drops {Distillate (Ark) of equal parts of Punarnava and
Palashamoola} two drops three times a day and Ayush-CT Capsule (Extract of
equal parts of Punarnava and Amalaki) 500mg. two capsules BD for 4months
2. Placebo- Distilled water two drops three times a day and glucose capsules 500mg.
two capsules BD for 4 months
Design of the study : Double blind Randomized controlled trial
Duration : Four months drug therapy with a follow up for two months
without drug.
Period of Study : Six months (Four months drug therapy and two months
follow-up) for each case. Total duration will be two years
to complete the trial.
Follow – Up : One follow-up will be carried out after two months of the
completion of treatment.
1. Age above 50 years and up to to 80 years
2. Both the sex
3. Immature cataract (confirmed by ophthalmoscopy, retinoscopy/iris shadow presence)
With any one or both of the symptoms
• Disturbance in vision (diplopia,polyopia,holes etc)
• Diminished visual acuity
1. Age below 50and above80 years
2. Mature cataract
3. Sluggish pupil reaction
484
4. Hypertension
6. Glaucoma
7. Any other illness causing notable visual morbidity
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
the proforma (Forms I & IA). Clinical assessment will be done during treatment (Form II). The
laboratory investigations will be carried out before and after the treatment.
Data on disturbance in vision and diminished visual acuity will be analyzed using
Improvement in visual acuity (Using near vision and distance vision chart-Snellen’s test
type) and disappearance of symptoms of disturbances in vision (Clinical assessment) will be
considered as significant, besides status of cataract examined through ophthalmoscopy, retinoscopy
and Iris shadow tests.
X. TRIAL MONITORING AND DATA ANALYSIS
XI. ETHICAL REVIEW
485
A consolidated amount of Rs.……. /- per visit will be paid to subjects
selected.
486
CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the trial on “Clinical Evaluation Of Ayush-CT Drops And Ayush-CT Capsule In improving the
quality of vision and Prevention Of Progress in senile immature cataract”

Relationship ___________________________________
487

Senile cataract (Linganasa) is a disease of common occurrence in all geographical areas
and in all races. The incidence, however, is distinctly more in tropical countries. The two factors
peculiar to tropical circumstances and responsible for this high incidence are higher concentration
of actinic rays in tropical sunlight, and the nutritional deficiency factors so significant in these areas.
It can be generally stated that in developing tropical countries, the age of 50 years and above is
considered a cataractogenous age and the degree of incidence increases as the age advances. It
is safe to assume that 60% people develop cataract by the age of 60 years. 70% by the age of
70 years, 80% by 80 years and 90% by 90 years of age.
The current lines of management include various surgical methods. There is no definite
medical treatment for this condition in the patients where surgical treatment is not suitable like
uncontrolled diabetes, cardiac disorders and so on. Ayurvedic literatures have recorded many
single drugs and compound formulations for the treatment of Linganasa/Timira. Drugs like
Punarnava, Amalaki, Palasha etc. possess various pharmacological actions like Chakshushaya
(Improves visual acuity), Timira hara (Effective in managing various disorders of vision) besides its
Rasayana effects that prevents free radical damage i.e. anti-oxidant effect.
instructions scrupulously. The study will take approximately six months to complete ( four months
for treatment and another two months for follow-up study). During this period, you are expected
to visit the hospital six times, once in a month during drug treatment and once at the end of 6th
month during the follow up.
If you are found eligible, you would be put on trial treatment OR placebo therapy
for four months. Daily dose of oral treatment consist of two 500-mg. capsules twice a day
along with eye drops two drops three times a day for four months
488
palpitation/tremor etc., noticed during the treatment period, this should be informed to the
489
BEFORE TREATMENT
1. Centre: ______________________________
4. Sr. No. of the Subject : ____________________________________________________
5. Address : _______________________________________________________________
1. Age above 50 years up to to 80 years
2. Both the sex
3. Immature cataract (confirmed by ophthalmoscopy,

retinoscopy/iris shadow presence) With any one or
both of the symptoms
4. Disturbance in vision (diplopia,polyopia, holes etc/

Diminished visual acuity)
5. Age below 50and above 80 years
6. Mature cataract.
7. Sluggish pupil reaction
490
9. Glaucoma
10. Hypertension
11. Person undergoing treatment for
12. Any other serious illness
If yes, specify: __________________________________________________
13. Any other illness causing notable visual morbidity
If yes, specify: __________________________________________________
If ‘YES’ to 1 – 4 and ‘NO’ to 5 – 13
If admitted, subject serial No: _________
No. of packets issued: _______________
Date: ____________ Signature of Investigator: _________________________
491
CASE REPORT FORM II- HISTORY
1. Centre: ______________________________
4. Address : _______________________________________________________________
Chief complaint with duration (in month) Yes (1) No (2)
10. Disturbance in vision
If Yes, duration in months _________________
492
11. Diplopia
If yes, duration in months __________________
12. Polyopia
If yes, duration in months _________________
13. Holes
If yes, duration in months _________________
14. Any other visual disturbances
If yes, (specify): __________________
Duration in months: _______________
15. Diminished visual acuity
If yes, details* &duration in months _________________
Visual acuity (Snellen’s test type)
Distant vision:
16. Right Eye: ___________
17. Left Eye: ___________
18. Both Eyes: ___________
Near vision:
19. Right Eye ___________
20. Left Eye ___________
21. Both Eyes ___________
22. History of cataract in family Yes (1) No (0)
If Yes, relation with patient _________________
493
23. Prakriti Vata 1 Pitta 2 Kapha 3
Sannipataja 7
EXAMINATION OF THE EYE
24. General examination Normal 1 Abnormal 2
If abnormal, specify abnormalities ____________________________________
Lens (Medoashrita patala)(ophthalmoscopy)
25. Colour: Gray Brown Transparent
26. Opacity: Central Peripheral Total
27. Position Normal 1 Displaced 2
28. Iris shadow Present 1 Absent 2
Vitreous Present (1) Absent (2)
29. Degenerative changes
30. Opacity
Pupil (Dristi mandal) Normal (1) Abnormal (2)
31. Size
Reaction Present (1) Absent (2)
32. Direct
33. Consensual
34. Retina (Asthiashrita patala)
If abnormal, specify ___________
Distant vision:
494
35. Right Eye ___________
36. Left Eye ___________
37. Both Eyes___________
Near vision:
38. Right Eye ___________
39. Left Eye ___________
40. Both Eyes___________
Glasses (Correction)
Right Eye Left Eye

Vision Sph Cyl Axis Vision Sph Cyl Axis Vision
41. NV
42. DV
Tonometry (Schitoz’s)
Intraocular pressure*
43. RE ________ mm/Hg
44. LE ________ mmHg
* 6-21 Normal
Date: ____________ Signature of Investigator: _________________________
495
(0, end of 1st, 2nd, 3rd, 4th, 5th & 6th month)
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Gender Male Female
7. Disturbance in vision
8. Diplopia
9. Polyopia
10. Holes
11. Any other visual disturbances (specify)
If Present, Specify___________________________
Distant vision:
12. Right Eye ___________
13. Left Eye ___________
496
14. Both Eyes ___________
Near vision:
15. Right Eye ___________
16. Left Eye ___________
17. Both Eyes ___________
18. Adverse reaction: Yes (0) No (1)
If yes, details: _______________________
Continuing (1)
Drop out (2) Reason:_____________________________
Date: ______________ Signature of Investigator: ___________________
497
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
PHYSIOLOGICAL PARAMETERS
(Before the treatment)
1. Centre: ______________________________
4. Address : _______________________________________________________________
8. Urine Sugar _____________________________________________________________
9. Blood Sugar - PP (mg./dl)
Date : __________________ Signature if Investigator : ___________________
498
CLINICAL EVALUATION OF THE EFFECT OF
TARPANA AYUSH-DE EYE DROPS, AYUSH-DE
CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA/PARISHUSKHA
NETRA)
Drug : Study Code:

AND SIDDHA
499
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500
CLINICAL EVALUATION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
I. BACKGROUND
In certain conditions, there is insufficiency of lubrication of eye and the conjunctiva
becomes dry. Deficiency in any components of tear film, results in dryness of the eye, due to the
appearance of dry spots on the corneal and conjunctival epithelium. Sushruta considered
shushkakshipaka as an individual disease and classified under sarvagata netra rogas. Even though
there is no separate entity such as Parishushka netra in classics, authors of different texts
mentioned the above condition while describing the therapeutic procedure adapted for the
management of eye disease. Conditions like Ativishushka netra, Ashrusrava rahita netra,
Asnigdha netra are mentioned in Nibandha samgraha (one of the commentaries on Sushruta
Samhita.)
There are many conditions which cause dryness of the eyes. Hypofunction of lacrimal
glands (eg. sjogren’s syndrome, sarcoidosis, lymphoma, leukemia amyloidosis.), mucin deficiency
(e.g. vitamin A deficiency), conjunctival scarring, (e.g. trachoma, Stevans Johnson syndrome,
pemphigold, chemical burns, chronic bacterial or viral conjunctivitis, irradiation and miscellaneous
causes such as mumps, deficient blinking etc.).
(Kapha is responsible for sanigdhatwa (oiliness) sthiratwa (structrual and functional integrity
of body systems) by means of its qualities like gurutwa and shitatwa.) Tarpaka kapha, one of the
five varieties of Kapha, situated in siras is responsible for the integrity of sense organs
(akshitarpana). According to Dalhana, the term aksha refers to sense organs like netra. Collective
function tear film components can be correlated with the function of the tarpakakapha.
Clinical studies conducted with topical and internal use of Ghrita prepared with the Haridra
and Daruharidra has shown significant improvement in subjective parameters like Dryness,
Redness, Photophobia etc. Pharmacological actions such as chaksushya (conducive to vision),
netrya (conducive to eye), netra ruja hara (analgesic ophthalmic action) are attributed to haridra,
daruharidra and ghrita from which the formulation under taken for the study was prepared. The
response obtained after the clinical study could be well understood with the above
pharmacological actions ascribed to various ingredients 1&2
References
1. Dry Eye Syndrome and its management – A clinical study, JRAS, Vol.XXII, No.1-2, (2001)
pp.17-24.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi.
3. Sushruta Uttarasthana Chapter 9/18-22
501
II. OBJECTIVE
To evaluate the effect of Ayush-DE drops and Akshi tarpana in dry eye syndrome
(shushkakshipaka / parishuskha netra)
III. CENTRE
No. of groups : Four groups
No of patients in each group : 25
Type of Study : Open
Level of Study : OPD/IPD
Period of Study : 4 months (3 months treatment and one
month follow up Study with Distilled
Water)
Treatment:
Group-I
1. Akshi Tarpana with Ayush-DE Ghrita {prepared with equal parts of Yashtimadhu
(Glycerrhiza glabra)} for five days.
2. Installation of Ayush-DE drops {Yashtimadhu (Glycirrhiza glabra)} three drops
three times a day for three months.
Group-II
Installation of Ayush-DE drops {prepared with Yashtimadhu (Glycirrhiza glabra)} three
drops three times a day for three months.
Group-III
Artificial tears for three months (conventional)
Group IV
Autoserum (optional)
Procedure of tarpana
Local application of tila taila around the eye orbit followed by mild sudation will be given
as purvakarma. Concentric boundary should be made around each orbit with paste of masha
choorna (Powder of Phaseolus mungo). 20 ml of lukewarm medicated ghee should be filled and
allowed to retain in the boundary for twenty minutes. After the prescribed period, ghrita will be
removed with cotton pads followed by removal of the boundary.
502
1. Dryness of the Eye with or without
a) Sandy and scratchy feeling
b) Pain / pricking sensation
c) Photophobia
d) Mild reddness/ Mild blepharitis
e) Less flow of tears even when exposed to irritant odour and fumes
f) Foreign body sensation
g) Mild reddness
3. Tear film break-up time less than 10 seconds
4. Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on
the cornea.
5. Schimers tests positive < 10 mm (exact measurement)
6. Chronicity upto six months.
1. Age below 20 years above 40 years
2. Chronicity above 6 months.
3. Corneal ulcer
4. Degenerative condition of conjunctiva
5. Extra ocular and intra ocular infections
6. Contact Lens users
7. Systemic disease causing Dry Eye Syndrome (Physicians remarks)
aggravate, which requires urgent treatment, such subjects may be withdrawn from the trial and
The full details of history including any associated diseases and physical examination of the
patients will be recorded as per the Proforma (Forms I & II). Clinical assessment will be done
503
before drug administration on every 15th day during the treatment and at the end of 3rd month
during follow up (Form III). Required laboratory investigations will be carried out to exclude
cases as specified in the criteria for exclusion. (Form-IV)
Relief in subjective parameters viz. dryness, pain, redness, foreign body sensation and
improvement in tear film breakup time, Schimers tests will be considered as significant response.
mail.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centre’s should give
clearance certificate before the project is initiated. Patient’s information sheet and
informed consent form should be submitted alongwith project proposal for approval by
IEC. Both should be maintained in duplicate with one copy given to the patient at the
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.------/ per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th day & end of 3rd month (6 times)
504
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the “Clinical evaluation of the effect of tarpana and eye drops in the management of dry eye
syndrome (shushkakshipaka / parishushka netra)”

Relationship ___________________________________
505
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)

In certain conditions, there is insufficiency of lubrication of eye and the conjunctiva
becomes dry. Deficiency in any components of tear film, results in dryness of the eye, due to the
appearance of dry spots on the corneal and conjunctival epithelium. Sushruta considered
shushkakshipaka as an individual disease and classified under sarvagata netra rogas. Some clinical
studies on this condition revealed promising results in managing this condition. The present study
aims at evaluating effect of topical and internal medication in the management of dry eye syndrome.
Approximately 50 patients will be included in the trial.
instructions scrupulously. The study will take approximately4months to complete (3 months of
medication and thereafter 1 month follow up). During this period, you are expected to visit the
hospital initially for five days for Tarpana. During the trial you are expected to visit 8 times, at an
interval of every 15 days in first 3 months and at the end of 4th month.
physical examination; required objective tests will also be done.
palpitation/tremor etc., noticed during the treatment period, this should be inforrmed to
the Principle Investigator.
506
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
BEFORE TREATMENT
1. Subject Name : ......................................................... Age ................ Sex .........................
2. Centre : ...................................
3. Code No. (of clinical trial) :
4. Patient No.
Third 3 Fourth 4
CRITERIA FOR SELECTION Yes No
1. Dryness of the Eye with or without
2. Sandy and scratchy feeling
3. Pain / pricking sensation
4. Photophobia
5. Mild redness/ Mild blepharitis
6. Less flow of tears even when exposed

to irritant odor and fumes
7. Foreign body sensation
8. Mild redness
507
10. Tear film break-up time
11. Rose Bengal staining showing devitalized

epithelium of conjunctiva and mucus plaques
on the cornea. (Value)
12. Schimers tests positive (Value)
13. Chronicity upto 6 months
EXCLUSION CRITERIA Yes No
14. Age below 20 years above 40 years
15. Chronicity above 2 years
16. Corneal ulcer
17. Vitamin-A deficiency
18. Degenerative condition of conjunctiva
19. Extra ocular and intra ocular infections
If Sl. No. 1-13 is ‘Yes’ and Sl. No. 14-19 are ‘No’
Date ______________ Signature of Investigator____________________
508
COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CASE REPORT FORM -II HISTORY
1. Subject Name : ......................................................... Age ................ Sex .........................
2. Address : ..............................................................................................................................
3. Date of Asmission : ................................................ Date of Discharge ...............................
4. Centre : ...................................
6. Patient No.
Third 3 Fourth 4
1. Environment : __________________
2. Income 10, 000 & >
10, 000 & <
509
Chief complaint with duration (in month)
9. Dryness of the eye
10. Sandy and scratchy feeling
11. Pain / pricking sensation
12. Photophobia
13. Mild redness/ Mild blepharitis
14. Less flow of tears even when exposed

to irritant odour and fumes
15. Foreign body sensation
16. Mild redness
17. Others specify: ......................................................................................................................
19. Duration of disease (in months):
PERSONAL HISTORY
20. Diet Veg 1 Non-veg 2 Lacto-ova veg 3
21. Sharirik Prakriti (please see separate attached sheet)
Sannipataja 7
PHYSICAL EXAMINATION: Normal Abnormal
510
SYSTEMIC EXAMINATION:
Normal Abnormal
EXAMINATION OF THE EYE
Vision examination
Normal Abnormal
If abnormal, specify_______________________________________________________
Movement
Normal Abnormal
If abnormal, specify_______________________________________________________
Lacrimal System Normal Abnormal
(ashruyantra)
If ‘abnormal’ specify, ______________________________________________________
Conjunctiva (bulbar)
Congestion (GRADE 0-5) _________________________________
Oedema (GRADE 0-5) _________________________________
Haemorrhage (GRADE 0-5) _________________________________
Redness (GRADE 0-5) _________________________________
Nodule (GRADE 0-5) _________________________________
Conjunctiva (tarsal)
Tarsal scarring (GRADE 0-5) _________________________________
Fllicles (GRADE 0-5) _________________________________
Others (GRADE 0-5) _________________________________
511
Sclera (Sukla mandala)
Change in colour (GRADE 0-5) _________________________________
Pigmentation (GRADE 0-5) _________________________________
Nodule (GRADE 0-5) _________________________________
Congestion (GRADE 0-5) _________________________________
Cornea (Krishna mandala)
Lusture Normal Lustureless
Vascularisation Sensation 1 Present Absent 2
Reduced 3
Epithelial status Tearfilm meniscus Defect / erosion / desquamated
Tear film break-up test _________________________________
Rose Bengal staining _________________________________
Shchimer tests _________________________________
512
(0 day, 15th, 30th, 45th, 60th, days & end of 3rd month)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Dryness of the eye (GRADE 0-5) _______________________
8. Sandy and scratchy feeling(GRADE 0-5) _______________________
9. Pain / pricking sensation (GRADE 0-5) _______________________
10. Photophobia (GRADE 0-5) _______________________
11. Redness/ Mild blepharitis (GRADE 0-5) _______________________
12. Less flow of tears even when exposed to _______________________

irritant odors and fumes (GRADE 0-5).
13. Foreign body sensation (GRADE 0-5) _______________________
14. Redness (GRADE 0-5) _______________________
15. Others (specify) Present 1 Absent 2
513
Clinical Tests
15. Tear film break-up test: ______________________________
16. Rose Bengal staining: ______________________________
17. Shchimer tests: ______________________________
18. Status of the patient: Continuing 1 Drop out 2
Reason: ____________________________________________
514
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
(Sl.No.5 to 17will be done at 0 & 15th day and 18-20 at the end of 1st, 2nd month,
3rd and 4d month)
1. Centre: ______________________________
4. Address : _______________________________________________________________
8. TLC (Cells/Cmm.): ___________________
9. DLC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) _______
9. Hb (g/dl): ___________________
10. Platelet: ___________________
11. ESR (1st hour.) (mm): ___________________
12. Blood Sugar Fasting & PP (mg./dl): ___________________
13. B. Urea (mg./dl): ___________________
14. S. Creatinine (mg./dl): ___________________
15. Liver function tests (SGOT/SGPT): ___________________
16. Lipid profile: ___________________
515
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516
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS
IN SIMPLE ALLERGIC CONJUNCTIVITIS
(KAPHAJA ABHISHYANDA)
Drug : Study Code:

AND SIDDHA
517
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518
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN SIMPLE
ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
I. BACKGROUND
Allergic conjunctivitis1 is commonly occurring ocular problem in day-to-day ophthalmic
practice. Apart from phlyctenular conjunctivitis as a manifestation of endogenous allergy and spring
catarrh an exogenous allergy, the conjunctiva may react to many other sensitizing factors viz.
external, physical or chemical. Allergy as a cause of conjuctival congestion has however been
exaggerated. (Anything which does not fall into the description of a specific condition and any
condition show aetiology is undermined is often attributed to allergy.) This evasive diagnosis is
further supported by the favorable response of the conjuctival congestion to steroids (Dhanda et
al. 996).
Current line of management advocates the use of topical steroids/ decongestant drops/
Mast Cell Stabilizers along with anti-histamine agents, is found unsatisfactory and temporary,
should be repeated only during exacerbations, besides their adverse effects (Anonymous, 1996).
At this juncture it becomes essential to explore safe effective drug which could effectively tackle
such conditions. Ayurvedic literatures have recorded more than 60 plant drugs useful in the
treatment of various eye disorders. Daruharidra (Berberis aristata DC.), one of such agents has
potent anti-inflammatory and anti-allergic action.
[Netrarujahara (Analgesic ophthalmic action), Netrakanduhara (anti-allergic action),
Kaphajabhisyandahara (Effective in allergic ocular conditions) (SrikanthN.2000).] Berberine, an
alkaloid isolated from B. aristata and its salt berberine hydrochloride produced depressant effect
on histamine, 5-HT and Bradykinin. It exhibited anti-inflammatory property on acute, sub-acute
and chronic models of inflammation. Clinical application of berberine in chronic trachoma patients
by intraconjuctival injection proved highly effective. The effect confirmed by scientific studies, that
revealed “Berberine may prove practical remedy for large scale use in trachoma patients. Berberine
in a dose of 0.5 mg per egg protected 50-75% chick embryos from the lethal effect of the
trachoma organisms inoculated into the yolk sac”. The results supported the ancient Ayurvedic
claims on the use of the plant B. aristata in eye diseases and clinical report on the efficiency of
berberine in trachoma. (Bhatnar1970, Halder 1970,Imaz 1977, Verma. RL.1993, Anonymous
References
1. Ambika Dutta Sashtri (1989) Sushruta samhita (text with Hindi commentary) Uttara Sthana, VIIth
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi
519
1996) it may be concluded that the decoction of the Daruharidra may be successfully employed
in the management of acute and chronic conjunctivitis of varied aetiology.
A clinical study of 52 cases of Allergic conjunctivitis was conducted to evaluate the effect
of a potent Anti- inflammatory, and Anti- Allergic Indigenous Ophthalmic Drug -Daruharidra
(Berberis aristata DC.). Topical administration (Aschyotana) with decoction of root bark of
Daruharidra (Berberis aristata DC.) was scheduled for 5 days and Aschyotana procedure was
repeated for the same period at an interval of 7days.Follow up observation was done for one
month. This study reveled that the scheduled therapy is highly valuable in the management of
allergic conjunctivitis of varied aetiology. The response obtained may be explained with the anti-
allergic, anti-inflammatory, antibacterial, properties attributed to the drug (Bhatnar1970, Halder
1970, Imaz 1977, Sabir 1976, Verma. RL. 1993, Anonymous 1996) besides its Netrarujahara
(Analgesic Ophthalmic action), Kaphajabhisyandahara (effective in allergic ocular conditions), and
Netrya (Conducive to Eye) actions.
II. OBJECTIVE
To evaluate the effect of Ayush –AC eye drops in simple Allergic Conjunctivitis (Kaphaja
Abhishyanda)
III. CENTRE
Central Research Institute (Ay.), New Delhi
Sample Size _ 90 patients (2 Groups)
Design of the study – Randomized Control Trial
Ayush-AC Eye Drops {containing equal parts of Daruharidra (Berberis aristata) and
Sirisha (Albizia libeck)} three times a day for 15 days.
Control - Distil water + preservative used in the drug
Duration of the study - 1½ months including 15 days drug therapy with
a follow up for one month without drug.
Period of Study - 15 days for each case. Total duration will be one
year to complete the trial.
Follow – up - One follow-up will be carried out after one week of
the completion of treatment.
1. Patients presenting with cardinal features of allergic conjunctivitis viz.
• Redness
520
• Itching
• Lacrimation
• Irritation
• Photophobia.
2. Age >10 yrs.
3. Conjunctival smear negative for bacterial/viral (optional)/fungal infection.
1. Age below 10 yrs
2. Conjunctival smear showing evidence of infection.
Clinically diagnosed cases of
3. Infective conjunctivitis
4. Parasitic infestation
aggravates, which requires urgent treatment, if no response after one week of treatment such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
the proforma (Forms I & II). Clinical assessment will be done before drug administration on 15th
day during drug therapy and 30th day & 45th during follow up (Form III). Required laboratory
investigations i.e. Stool examination (3 samples), TC (Cells/Cmm.), DC (P, L, E, M and B),
Absolute eosinophil, Hb% (g/dl), ESR (1st hour.) (mm), Blood Sugar – random (mg./dl,
Conjunctival swab for light microscopy and C&S evaluation will be carried out to exclude cases
as specified in the criteria for exclusion. (Form-III)
IX. CRITERA FOR ASSESSMENT
Disappearance of Redness, Itching, Lacrimation, Irritation and Photophobia will be
consider ed as significant out come of the treatment.
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through
e-mail.
521
analysis.
A consolidated amount of Rs. ______/- per visit.
522
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the “Clinical Evaluation of Ayush –AC Eye Drops in simple Allergic Conjunctivitis (Kaphaja
Abshyanda)”

Relationship ___________________________________
523

Allergic conjunctivitis is commonly occurring ocular problem in day-to-day ophthalmic
practice. Apart from phlyctenular conjunctivitis as a manifestation of endogenous allergy and spring
catarrh an exogenous allergy, the conjunctiva may react to many other sensitizing factors viz,
external, physical or chemical. Experimental and clinical studies revealed that drugs undertaken in
the study viz. Daruharidra and Sirisha have significant effect of in the management of allergic
disorders including allergic conjunctivitis. The present study aims at evaluating effect of [Ayush-AC
capsules &] Ayush-AC drops in the management of allergic conjunctivitis.
instructions scrupulously. The study will take approximately 22 days to complete (15 days of
medication and thereafter one week of follow up). During this period, you are expected to visit
the hospital three times at the interval of one week.
physical examination, blood samples will also be taken to make sure that you are eligible for the
study.
524
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSKHA NETRA)
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
4. Date of Birth : Age (in yrs.) :
5. Address : ..............................................................................................................................
1. Patients presenting with cardinal features of

allergic conjunctivitis viz.
• Redness,
• Itching,
• Lacrimation,
• Irritation
• Photophobia.
2. Age >10 yrs
3. Conjunctival smear negative for bacterial/viral

(optional)/fungal infection.
4. Age below 10 yrs
525
5. Conjunctival smear showing evidence of infection.
6. Infective conjunctivitis
7. Parasitic infestation
If admitted: Serial No._______________ No of Packet issued_________________
Date ___________________ Signature of Investigator:____________________
526
Case Report form-II history
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
4. Patient No.
6. Address : ..............................................................................................................................
Indicate nature of work ...........................................................................
9. Total family members :
527
11. Redness
12. Itching
13. Photophobia
14. Lacrimation
15. Irritation
16. HISTORY OF PRESENT ILLNESS
I. Onset of disease Acute 1 (1) Insidious 2 (2)
II. Duration of disease (in months)
III. Factors aggravating the disease/chief complaints ______________________________
IV.Factors relieving main complaints __________________________________________
V. History of past illness, having relation with present illness : Yes No
If yes, Specify____________________________________________________________
VI. Contact with pets _____________________________________________________
17. PAST HISTORY Yes (1) No (2)
I. Working in agriculture field
II. Contact with pets
III. Hay fever, asthma, eczema
IV. Use of hair dye
V. Use of systemic antibiotics (Sulphanomides)
18. PERSONAL HISTORY
19. Diet: Veg 1 Non-veg 2 Lacto-ova veg 3
Fish-veg 4
528
20. Sharirik Prakriti: Vata 1 Pitta 2 Kapha 3
Sannipataja 7
21. Manas Prakriti : Sattva 1 Rajas 2 Tamas 3
Sattva-Rajas 4 Rajas-Tamas 5 Sattva-Tamas 6
Sama 7
22. EXAMINATION OF THE EYE (NETRA PARIKSHA)
I. Vision
II. Palpebral fissure (Vartma sukla sandhi) Wide 1 Narrow 2
III. Eyeball (Akshigolaka)
(a) Size Normal 1 (1) Microphthalmos 2 (2) Big 3
IV.Lids (Vartma)
(a) Position Normal 1 Drooping 2
(b) Thickness Present 1 Absent 2
(c) Inflammatory signs Present 1 Absent 2
(d) Lashes
Misdirection Present 1 Absent 2
Scantiness Yes 1 No 2
(e) Lidmargin
Ectropion Yes 1 No 2
Entropian Yes 1 No 2
V. Lacrimal System Normal 1 Drooping 2

(ashruyantra)
If ‘abnormal’ specify, ___________________
529
VI. Conjunctiva (bulbar) Yes (1) No (2)
Congestion
Conjunctival/CCC
Oedema
Hemorrhage
Redness
VII. Conjunctiva (tarsal) Yes (1) No (2)
Nodule
Others Yes
VIII. Sclera (Sukla mandala) Yes (1) No (2)
Change in colour
Pigmentation
Nodule Yes
Congestion
IX. Cornea (Krishna mandala) Present (1) Absent (2)
(a) Opacity
(b) Oedema
(c) Vascularisation
(d) Epithelial status
(e) Keratitis
X. Anterior Chamber
If abnormal, specify: .............................................................................................................
530
XI. Iris (Mamsa ashrita patala)
XII. Vitreous
Lens (Medoashrita patala)
(a) Opacity Present Yes (1) No (2)
XIII. Pupil (Dristi mandal)
XIV. Retina (Asthiashrita patala)
XV. IOP (Digital)
531
1. Centre: ______________________________
4. Address : _______________________________________________________________
7 Redness (Grade 0-5) _________________________________________
8 Itching, (Grade 0-5) _________________________________________
9 Photophobia. (Grade 0-5) _________________________________________
10 Lacrimation, (Grade 0-5) _________________________________________
11 Irritation (Grade 0-5) _________________________________________
12 Adverse reaction: _____________________________________________________
If yes, details____________________________________________________________
13 Overall impression of well-being by the Subject:
14 Status of the patient:
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: ______________________________
Date: ______________ Signature of Investigator__________________________
532
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH – AC EYE DROPS IN
CASE REPPOT FORM IV – LABORATORY INVESTIGATIONS
(Before treatment)
1. Centre: ______________________________
4. Address : _______________________________________________________________
Ova/Cyst____________ Occult Blood____________\
9. TC (Cells/Cmm.)_____________________
10. DC: P (%)_______ L (%) _______ E (%)________ M (%)________ B (%)_______
11. Absolute Eosinophils
12. Hb (g/dl): _______________
13. ESR (1st hour.) (mm) _______________
14. Blood Sugar – Randomized (mg./dl) _______________
15. Conjunctival swab for light microscopy and C & S evaluation
533
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534
CONNECTIVE TISSUE DISORDER
SECTION - VIII
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536
CLINICAL TRIAL ON EVALUATION OF EFFECT OF
JALAUKAVACHARANA IN DEEP VEIN THROMBOSIS
Treatment modality: Study Code:

AND SIDDHA
537
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538
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
I. BACKGROUND
Presence of thrombosis1 within a deep vein and accompanying inflammatory response in
the vessel wall is termed as thrombosis of deep vein. Most important consequences of deep vein
thrombosis is pulmonary embolism. More than 90% of pulmonary embolism arise from deep vein
thrombosis (William F.; Baker Jr., 1998) Pulmonary embolism has mortality of 18.3% without
treatment (Kemp PM, Traror D Batty V. et.al., 1996). Once the deep vein thrombosis occurs,
the risk of pulmonary embolism is high in first 72 hrs.
Risk factors for Deep Vein Thrombosis: Virchow triad of venous stasis, intimal injury and
hypercoagulable state was described in 1856 but still hold some truth.Extensive autopsy and clinical
studies have shown that 95% pulmonary embolism arise from deep vein thrombosis in the lower
limbs. Indwelling catheter in upper extremity veins like superior vena cava and right ventricle can
induce thrombosis.
Prevention of pulmonary embolism is the most important aim of treating the patient with
deep vein thrombosis. Prophylaxis is achieved by drug like heparin, LMW heparin or oral
anticoagulant and physical method like intermittent leg compression and graduated compression
stocking. In the early phase thrombolytic maybe useful in clot lysis.
Due to high cost of thrombolytics and LMW Heparin and bleeding and thrombo-
cytopenic side effect of heparin, the future Ayurvedic procedure Jalaukavacharana (leech
application) which has low cost and no side effect hold a strong promise for development of a
better procedure. Previous studies showed Jaloukavacharana as a promising treatment for deep
vein thrombosis. The same needs to be verified further.
II. OBJECTIVE
To evaluate the effect of Jalaukavacharana (leech application) in deep vein thrombosis.
References
1. Harisson’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1652
539
III. CENTRES
Sample size : 20 in each centre
Procedures of leech application:
1. Pre-operative procedure:
i Preparation of leech: Before using for blood letting, the leeches should be
purified by keeping them in water mixed with turmeric powder for some
time. Then, they should be shifted to the fresh water.
ii Preparation of patient: Thoroughly examined patient should be made to
take comfortable and convenient lying down position. The part of the
body where leech is to be applied should be cleanly washed and dried by
wiping with cotton cloth or swab. Antiseptic lotion or oil etc. should not be
used.
2. Operative procedure:
Then one or two leeches depending on the condition should be applied to the
swollen and indurated part of the limb. If the leech does not suck the blood, a drop of
milk or blood should be; put on the site. Still if leech fails to such the blood, mild prick
should be made on the skin. After the leech starts sucking the blood, it should be covered
with a wet cloth. If at biting site, pricking pain and itching appears, the leech should be
removed, if it does not leave, its mouth should be sprinkled with the turmeric powder.
3. Post operative procedure:
i Care of patient: After detachment of the leech, bleeding may continue. At
that time turmeric powder should be applied on the bleeding spot and
washed with cold water and dried by gently pressing with a gauze. Then
to enhance the healing process, Jatyadi Taila should be applied and
bandaged.
ii Care of leech: In order to make the leech fit for further use, it should be
made to vomit the sucked blood, by keeping it in the water mixed with
turmeric powder followed by holding it upside down and applying mild
pressure on the body of the leech from tail to mouth. After complete
vomiting it should be washed out with cold water and kept in the pot.
After 7 days, we can make use of the same leech for blood letting.
540
Duration of the Procedure- Application of leech will be done twice a week with an
interval of 3 days. Total duration of the procedure is 1 month.
Design of the study – Open Trial
Total period of study- 12 months
1. Both sexes
2. Between 25 years and 70 years.
3. Unilateral swelling of lower limb
4. Warmth and erythema over swelling
5. Tenderness over swelling
6. Calf pain (Posterior calf tenderness)
7. History of Immobilization for more than 2 weeks
8. Post menopausal hormonal replacement therapy
9. Patient with hemodynamically stable
10. Patient with positive finding of thrombosis on the basis of intravascular Doppler Study
1. Patient with hamodynamically unstable
2. Patient with Bleeding disorder
3. Patient with Respiratory failure
4. Severe CCF with EF < 30%
5. Severe uncontrolled diabetes
6. Acute MI
7. History of recent haemorrhagic stroke
During the course of trial treatment, if any serious condition develops which requires
urgent treatment; such subjects may be withdrawn from the trial and managed by the Principal
Investigator accordingly.
541
the proforma (Forms I & II). Clinical assessment will be done before and after the procedure. The
laboratory investigations and the physiological parameters will be recorded before and at the end
of treatment
Clinical symptoms, physiological parameters and laboratory parameters will be analysed
using appropriate statistical methods.
X. CRITERIA FOR ASSESSMENT OF RESULTS
Relief in clinical signs and symptoms will be considered as significant improvement.
The progress of the trial will be monitored by Monitoring Unit and staff of CCRAS
Headquarters, New Delhi).
Data analysis will be undertaken at the CCRAS Headquarters, New Delhi.
XII. ETHICAL REVIEW
Each participating center’s Institutional Ethical Committee (IEC) should give clearance
should be submitted alongwith project proposal for approval by IEC. Both should be maintained
542
the patient.
Name: ____________________________
CONSENT BY SUBJECT
clinical trial and the nature of treatment and follow-up, including the laboratory investigations to be
without having to give the reasons for doing so. I, exercising my free power of choice, hereby
give my consent to be included as a subject in the “Clinical trial on evaluation of effect of
Jalaukavacharana in deep vein thrombosis.”

Relationship ___________________________________
543

In spite of advances in the medical as well as surgical management of deep vein
thrombosis, limited success and their complications pose major concern for scientific community.
Jaloukavacharana or application of leech on affected part is proved to be beneficial in deep vein
thrombosis. It is the mildest, safest and painless way of extracting impure blood from the vein.
After certain preoperative measures the leech is allowed to suck the blood. After the leech leaves
the part, bandaging will be done. It takes about 15 minute to complete the procedure at each
sitting.
instructions scrupulously. The study will take approximately 1 month to complete the treatment and
another 6 months for follow-up study). During this period, you are expected to visit the hospital
twice a week. The interval between the 1st and 2nd visit will be 3 days.
If you are found eligible, you would be put on trial treatment for 1 month. At each visit,
you will be treated with the application of leeches.
544
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
1. Both sexes
2. Between 25 years and 70 years.
4. Warmth and erythema over swelling
8. Post menopausal hormonal replacement therapy
9. Patient hemodynamically stable
10. Patient with positive finding of thrombosis on the

basis of intravascular Doppler study
545
11. Patient hamodynamically unstable
12. Patient with Bleeding disorder
13. Patient with Respiratory failure
14. Severe CCF with EF < 30%
15. Severe uncontrolled diabetes
16. Acute MI
17. History of recent haemorrhagic stroke
18. Person undergoing treatment for any other serious

illness.
If admitted, Subject’s Serial No. ____________
Date: ____________ Signature of the Investigator ______________________
546
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
Standing for long time 3
Laborious 4
Sedentary 5
10. Warmth and erythematic over swelling
547
12. Cord like palpation over swelling
13. Cyanotic colour change over swelling
14. Paleness over swelling
History of Past illness Yes (1) No (0)
17. Orthopedic procedure on hip, knee
18. History of trauma (pelvis, femur, tibia)
19. History of intake of oral contraceptive
20. Post menopausal hormone replacement therapy
21. Non-hemorrhagic stroke with immobilization
22. Hypertension
23. Diabetes
24. Tuberculosis
25. Malignancy
26. Major hospitalization/surgery during past three years
If yes, specify ___________________________________________________________
27. Other complaints if any (Specify) _____________________________________________
Personal History
28. Diet Veg 1 Non –veg 2
29. Sleep Normal 1 Abnormal 2
30. Presence of anxiety No 2 Yes 2
548
31. Constipation No 2 Yes 2
Addiction
If yes specify: (a) Quantity (packs) ________________
If yes specify: (a) Quantity (packs) ________________
If yes specify: (a) Quantity (in ml.): ________________
35. Any other (specify): ________________________________________
36. Prakriti Vata 1 Pitta 2 Kapha 3
Sannipataja 7
37. Height (cm) ____________
38. Weight (kg) ____________
39. Pulse (per min) ____________
40. Blood Pressure Systolic(mm Hg) ___________
41. Blood Pressure Diastolic (mm Hg) ___________
42. Body temperature( o F) ___________
43. Respiration rate( per min) ___________
549
44. Anemia
45. Pallor
46. Clubbing
47. Edema
48. Deformities
If present, specify ________________
49. Lymphadenopathy
If present, specify: General 1 Local 2
(Area)__________________________________________________________________
Local Examination Absent (0) Present (1)
50. Pain in calf after dorsiflexion of foot
51. (Horranis sign)
52. CVS
53. CNS
55. Per abdomen
550
58. Locomotor system
Date:_________________ Signature of Investigator____________________
551
FORM III – CLINICAL ASSESSMENT
(0,………………..)
1. Centre: ______________________________
4. Address : _______________________________________________________________
10. Warmth and erythematic over swelling
12. Cord like palpation over swelling
13. Any cyanotic color change over swelling
14. Paleness over swelling
16. Any other non-specific symptoms
If yes, Present specify_________________________
552
17. Overall clinical assessment by the Investigator:
Continuing 1
Drop out 2 Reason: _____________________________
Died 3 Cause: _______________________________
553
FORM IV– LABORATORY INVESTIGATIONS AND PHYSIOLOGICAL
PARAMETERS
(Before and after the treatment)
1. Centre: ______________________________
4. Address : _______________________________________________________________
9. Hb%
10. Urine
Routine: ____________ Microscopic: ____________
9. Stool for occult blood: ____________
10. TLC: ____________
10. DLC: P (%) _______ L (%) _______ E (%) _______ M(%) _____ B (%)_______
11. ESR: ____________
12. BT: ____________
13. CT: ____________
554
14. PT: ____________
15. APTT: ____________
16. Platelet count : ____________
17. Lipid profile: ____________
18. Serum total cholesterol: ____________
19. Serum triglyceride: ____________
20. High density lipoprotein: ____________
21. Very low density lipoprotein: ____________
22. X-Ray Chest: ____________
23. ECG 12 leads: ____________
24. LFT : S.Bilirubin, SGOT, SGPT, S.Alkaline phosphatase, S.Albumin, S.Gobulin, A/G ratio
25. KFT: BUN, S.creatinine, Blood sugar, Serum Antithrombin,
26. Blood sugar
Fasting: ____________ Post Prandial: ____________
27. Serum Antithrombin
28. S.Sodium,
29. S.Potassium
30. USG:Duplex venous ultra-sonograph (B-mode) –colour droppler
31. Real time B-mode Compression Ultrasound
Date:________________ Signature of Investigator_______________________
555
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556
GERIATRIC DISORDERS
SECTION - IX
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558
RASAYANA DRUGS IN HEALTHY ELDERLY PERSONS
Treatment modality: Study Code:

AND SIDDHA
559
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560
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS
I. BACKGROUND
The World Health Organization (WHO) has defined Health as a state of physical, mental
and social wellbeing and not only the absence of disease or infirmity. Over the years, this definition
has changed and now Health is seen as a more holistic state including spiritual component in it.
This present definition of Health by WHO closely resembles the definition laid down in Ayurvedic
texts, more than 3000 years ago. The emphasis on maintaining good health or Swasthya is crucial
to Ayurveda. Ayurveda has presented a total holistic approach for upliftment of body and mind as
well as spirit. Whatever is possible through the control of mind and prana, can be acquired
through Rasayana. Rasayana therapy1 (Rejuvenating group of medicines) aims specially at the
promotion of strength and vitality by replenishing rasa and other Dhatus. The other benefits
secured by Rasayana therapy are promotion of memory and intelligence, immunity against disease
and decay, preservation of youthfulness, lustre, complexion and voice.
Rasayana is of three types according to their effect – 1. Ajasrika (nutritional) 2. Kamya
(desirable) and 3. Naimittika (conditional) and of two types according to the methods of
application - 1. Kutipravesika (confined treatment under specified atmosphere) and 2. Vatatapika
(usual out patient treatment).
There are numerous rasayana drugs among which important ones are Amalaki, Bhallataka,
Nagabala, Pippali, Aswagandha, Shilajit and Svarnabhasma. Brahmi, Shankhapushpi, Guduchi and
Yastimadhu are particularly intellect promoting (Medhya) rasayana drugs though they also promote
physical strength.
A series of clinical and experimental studies have already been conducted to assess the
Rasayana effect of many single and compound preparations. The studies on Chyavanprasa and
Amalaki Rasayana showed significant health promotive effect in elderly volunteers. The Pippali
Ksirapaka provided significant Naimittika rasayana effect in the patients of Tuberculosis, Asthma
and Arthritis reflected through increase in body weight, nitrogen retention, serum protein and
haemoglobin.
References
1. Kasinatha Sastri (1970), Caraka samhita Part-II, First edition, The Chowkhamba Sanskrit Series
Office, Gopal Mandir Lane, P.O. Chowkhamba, Post Box – 8, Varanasi – 1, India.
561
The study on the Medhya Rasayana effect of Shankapushpi, Brahmi and Mandukaparni
showed significant improvement in neurological and psychological parameters. The effect of Brahmi
on acetylcholine, acetylase and cholinesterase has been better than Mandukaparni. Similar studies
were also conducted on Satavari and Vacha with encouraging results.
Aswagandha when administered to 106 apparently normal healthy male volunteers in the
age group of 50-59 years was found to have anti-aging effect. Another study established the
haematinic effect of Aswagandha when administered with milk for 60 days to 60 children. The
effect of another Ayurvedic compound consishting of
Shatavari, Punarnava, Bala, Guduchi, Amalaki and Yasti in 50 apparently healthy male
volunteers in the age group of 45-50 years indicated that the compound has capability of restoring
the age - related functional impairments. A series of clinical studies conducted in different institutes
revealed that Amalaki (Emblica officinalis) as an effective remedy for different gastrointestinal
problems besides its Rasayana effect.
II. OBJECTIVES
• To observe the effects of Rasayana regimen (Triphala churna 5gm OD at night and
Ashwagandha churna 5gm OD at morning daily with water for 4 months) on physical
performance, quality of life and metabolic milieu.
• To observe the clinical safety of Rasayana regimen on clinical & laboratory parameters.
• Effect of Rasayana regimen in apparently healthy elderly on
a. Physical strength
b. Balance
c. Sleep
d. Urge incontinence
e. Constipation
f. Stress level
g. Quality of life
h. Vague ache and pains/ stiffness
i. Appetite
2. Adverse effect of regimen
a. In apparently healthy elderly person with no systemic disease
b. In person with systemic disease like hypertension and drug interactions
562
III. CENTRES
Sample Size: 50 subjects per center (Total 250 participants)
Drug: Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at morning
daily with water for 4 months.
Design of the study: Multicentric open clinical trial
Duration of the study: 4 months.
2. Apparently healthy
3. Co-operative and fully conscious
2. Severe bronchial Asthma /COPD
3. Cancer
4. Dementia < 24 score
5. Any symptomatic cardiac disease
6. Chronic debilitating conditions like hepatic/ renal insufficiency (Confirmed through history/
clinical examination)
7. Any acute illness/ serious illness
8. Fever/ delirium
1. Any serious intercurrent illness
2. Any serious adverse effect or drug interaction
563
A. The full details of history and physical examination of the patients will be recorded as per
the Case Record Forms (I & II). Clinical assessment including recording of common signs/
symptoms of suspected ADRs will be done before drug administration, at the end of 1st,
2nd, 3rd & 4th month of treatment (Form III). Laboratory investigations will be carried out
before drug administration, at the end of 2nd and 4th month of treatment (Form IV).
IX. FOLLOW - UP
Monthly follow-up will be carried out at the end of each month during the four months
treatment period.
Clinical symptoms, physiological parameters and laboratory parameters will be analyzed
using SPSS 15.0 version with appropriate statistical methods.
The progress of the trial will be monitored by field visits by Monitoring Unit - CCRAS
HQ, New Delhi. Data analysis will be carried out at the Monitoring Unit.
XII. ETHICAL CLEARANCE
Each participating centre’s Institutional Ethics Committee (IEC) should give clearance
certificate before the project is initiated.
a. List of Clinical Symptoms to be taken into account for assessment using VAS (Visual
Analogue Scale):-
1. Dizziness
2. Constipation
3. Urge incontinence
4. Aching muscles
5. Joint pain
6. Joint stiffness
7. Sleep abnormality
8. Loss of appetite
9. Vague pain
10. Fatigue
564
11. Generalized weakness
b. Clinical parameters to record
1. Height
2. Weight
3. Pulse rate
4. Blood pressure
Supine (diastolic/systolic__________)
Standing (diastolic/systolic__________)
Orthostatic hypotension – Yes/ No
5. Upper mid arm circumference
6. Skin fold thickness
7. BMI (body weight in Kgs./Height in meters2)
8. Waist circumference
9. Waist: hip ratio
10. Grip strength both hands
11. Get up and go test
12. Walking distance in 1 min.
13. General physical examination
c. Scores
1. Geriatric depression score
2. WHO-QOL score/ CDC score for health quality
3. HMSE (Hindi version of mental system evaluation)
4. Hamilton anxiety scale
d. Laboratory investigations
1. Complete haemogram (Complete blood picture)
2. GBP for anemia
3. Complete urine examination
565
4. Serum Iron
5. TIBC
6. Plasma glucose
a. Fasting
b. Post prandial
7. Lipid profile
a. HDL
b. LDL
a. Serum proteins
i. Albumin
ii. Globulin
b. Serum bilirubin
i. Total
ii. Direct
c. SGPT
d. SGOT
e. Serum Alkaline Phosphatase
9. Serum triglycerides
11. Serum electrolytes
a. Blood urea
b. Serum creatinine
13. Serum uric acid
14. Serum Thyroid Stimulating Hormone (TSH)
15. Serum calcium
566
16. Serum phosphates
e. Special tests
1. ECG
2. Pulmonary Function Test (PFT)
f. Marker of inflammation
1. C Reactive Proteins (CRP)
2. TNF ?
3. IL-6
g. Serum melatonin
h. Free radical system
a. Malonyl aldehyde
b. Catalase
c. Super oxide dismutase
d. Glutathione
e. Peroxidase
i. Prostate specific antigen
j. Test for insulin resistance
567
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I, exercising my free power of choice, hereby give my consent to be included as a
participant in the clinical trial of Triphala churna 5gm OD at night and Ashwagandha churna 5gm
OD at morning daily with water for 4 months on the general health of the aged persons.

Relationship ___________________________________
568
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
Ayurveda has laid emphasis on maintenance of positive health and prevention of diseases,
besides management/ treatment of diseases. Rasayana Therapy of Ayurveda promotes health of
individuals especially elderly persons. The present study is aimed to evaluate selected Ayurvedic
Rasayana drugs for their efficacy in the promotion of health of elderly people.
You are invited to participate in this study where you will be provided with the trail drugs
and require to take Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at
morning daily with water for 4 months. Previous observations in clinical and experimental studies
have shown promising effect of these drugs in the promotion of health. About 250 healthy elderly
persons from this and other hospitals around the country will be taking part in this study.
instructions scrupulously. The study will take approximately 16 weeks to complete. During this
period, you are expected to visit the hospital five times. The interval between the first, second,
third, fourth and fifth visits will be four weeks (one month).
physical examination, ECG and an X-ray, Blood and urine samples, etc. will also be taken. This
is to make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 16 weeks. At each visit,
you will be supplied with sufficient quantities of drugs to last until your next visit.
569
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
3. Cooperative and fully conscious
5. Severe Bronchial Asthma/ COPD
6. Cancer
7. Any symptomatic cardiac disease
8. Chronic debilitating conditions like hepatic/ renal

insufficiency (Confirmed through history/ clinical
examination/ laboratory findings*)
9. Dementia (Score <24 )
10. Any acute illness/ serious illness
570
11. Fever/ delirium
If admitted, Subject Serial No.: ______________
Date: ____________ Signature of the Doctor __________________
* Normal range of values for Sl. No. 8
A. Liver function tests
1. S. Bilirubin
• Total: 0.3 – 1.0 mg/dl
• Direct: 0.1 – 0.3 mg/dl
2. SGPT: 0 – 35 IU/L
3. SGOT: 0 – 35 IU/L
4. S. Alkaline phosphatase: 30 – 120 IU/L
5. S. Proteins (Total): 5.5 – 8.0 g/dl
• Albumin: 15 - 40 g/dl
• Globulin: 2.0 – 3.5 g/dl
B. Renal function tests
6. Blood urea: 15 – 40 mg/dl
7. S. Creatinine: < 1.5 mg/dl
571
2. Centre :__________________
3. Sr. No. of the Subject : ___________________________________________________
4. Subject Name : __________________________________________________________
5. Gender Male (1) Female (2)
D D M M Y Y
6. Date of Birth : Age (in years.)
7. Address : ..............................................................................................................................
10. Type of living arrangement
Living alone 1
Living with his/her spouse 2
572
Living with his/her family 3
Living in an old age home 4
Others (specify) 5
11. Income (per capita per month) of the participant and Head of the family
in Rs __________________________________________________________________
A. Chief complaint with duration in days

in days
12. Dizziness
13. Constipation
15. Aching muscle
16. Joint pain
17. Stiffness
18. Sleep abnormality
19. Loss of appetite
20. Vague pain
21. Fatigue
22. Generalized weakness
B. Recurrent frequent attacks of No (0) Yes (1)
23. Fever
If yes, indicate frequency of attacks in last six months: ____________________________
24. Rhinitis/ upper respiratory tract infection
573
25. Urinary tract infections
26. Other complaints (Specify) _________________________________________________
C. History of Past illness: No (0) Yes (1)
27. Tuberculosis
28. Major hospitalization/ surgery during past three years
If yes, specify ___________________________________________________________
D. Personal History
29. Diet: Veg (1) Non-veg (2)
Addictions Yes (1) No (0)
30. Alcohol
31. Tea/ Coffee more than 4 times a day
32. Tobacco
If Yes, Chewing (1) Smoking (2) Both (3)
33. Prakriti Vata Pitta Kapha
Vata-Kaphaj Vata-Pittaja Pittaja-Kaphaja
Sannipataj
34. Deformities Absent 0 Present 1
If present, specify _________________________________________________________
35. Lymphadenopathy Absent 0 Present 1
If present, specify, General 1 Local 2
Area __________________________________________________________________
574
E. General systemic examination Normal (0) Abnormal (1)
If abnormal, details _____________________________________________________
39. Vision
40. Hearing
42. Central nervous system
43. Cardiovascular system
F. Presence of any of the following symptoms
44. Burning sensation in abdomen
45. Nausea
46. Diarrhoea
47. Skin rashes
Date: ____________ Signature of Investigator _______________________
575
CASE REPORT FORM III A – CLINICAL ASSESSMENT
(ON 0 DAY)
1. Centre: ______________________________
3. Sr. No. of the Subject: ____________________________________________________
4. Name of the Subject: _____________________________________________________
A. Clinical Symptoms Visual Analogue Scale
6. Dizziness
7. Constipation
9. Aching muscles (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
10. Joint pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
11. Joint stiffness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
12. Sleep abnormality (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
13. Loss of appetite (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
14. Vague pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
15. Fatigue (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
16. Generalized weakness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
576
Normal (0) Impaired (1)
17. Vision
18. Hearing
19. Any other non-specific symptoms Absent (0) Present (1)
If present, specify_________________________
B. Physical Examination
20. Height (cm) _____________
21. Weight (kg) _____________
22. Pulse rate (per min) _____________
23. Body temperature (oF) _____________
24. Blood Pressure – Supine Systolic (mm Hg) _____________
25. Blood Pressure – Supine Diastolic (mm Hg) _____________
26. Blood Pressure – Standing Systolic (mm Hg) _____________
27. Blood Pressure – Standing Diastolic (mm Hg) _____________
28. Orthostatic hypertension: Yes (1) No (2)
29. Upper mid arm circumference (cm.) _____________
30. Skin folds thickness (mm) _____________
31. Grip strength (Right hand) (Kg) _____________
32. Grip strength (Left hand) (Kg) _____________
33. BMI (basal metabolic index – wt./ ht.2) _____________
34. Waist circumference (cm.) _____________
35. Waist: hip ratio _____________
577
37. Get up and go test _____________
38. Walking distance in 1 min. _____________
C. Score system
39. Geriatric depression score: _____________
40. WHO-QOL Score/ CDC score for health quality: _____________
41. HMSE (Hindi version of mental system evaluation): _____________
42. Hamilton anxiety scale: _____________
D. No. of sachets issued:
a. Aswagandha Churna sachets _____________
b. Triphala Churna sachets _____________
Date: ______________ Signature of Investigator: ______________________
578
CASE REPORT FORM III B – CLINICAL ASSESSMENT
(ON 30TH DAY, 60th DAY, 90th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)
1. Centre: ______________________________
A. Clinical Symptoms Visual Analogue Scale
6. Dizziness
7. Constipation
9. Aching muscles (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
10. Joint pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
11. Joint stiffness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
12. Sleep abnormality (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
13. Loss of appetite (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
14. Vague pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
15. Fatigue (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
16. Generalized weakness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)
579
Normal (0) Impaired (1)
17. Vision
18. Hearing
19. Any other non-specific symptoms Absent (0) Present (1)
If present, specify_________________________
B. Physical Examination
20. Height (cm) _____________
21. Weight (kg) _____________
22. Pulse rate (per min) _____________
23. Body temperature (oF) _____________
24. Blood Pressure – Supine Systolic (mm Hg) _____________
25. Blood Pressure – Supine Diastolic (mm Hg) _____________
26. Blood Pressure – Standing Systolic (mm Hg) _____________
27. Blood Pressure – Standing Diastolic (mm Hg) _____________
28. Orthostatic hypertension: Yes (1) No (2)
29. Upper mid arm circumference (cm.) _____________
30. Skin folds thickness () _____________
31. Grip strength (Right hand) (Kg) _____________
32. Grip strength (Left hand) (Kg) _____________
33. BMI (basal metabolic index – wt./ ht.2) _____________
34. Waist circumference (cm.) _____________
35. Waist: hip ratio _____________
580
37. Get up and go test _____________
38. Walking distance in 1 min. _____________
C. Score system
39. Geriatric depression score: _____________
40. WHO-QOL Score/ CDC score for health quality: _____________
41. HMSE (Hindi version of mental system evaluation): _____________
42. Hamilton anxiety scale: _____________
D. Presence of any adverse reactions Absent (0) Present (1) Duration

(in days)
45. Nausea
47. Diarrhoea
49. Skin rashes
47. Overall clinical assessment by the Doctor:
Improved 1 (1) No change 2 (2) Deteriorated 3 (3)
Continuing 1
Completed 2
Drop out 3 Reason: ______________________________________
Died 4 Cause of death: _______________________________
581
D. No. of sachets issued (if continuing):
a. Aswagandha Churna sachets __________________
b. Triphala Churna sachets __________________
Date: ______________ Signature of Doctor _____________________
582
(ON 0 DAY, 60th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)
1. Centre: ______________________________
A. Complete urine examination
6. Routine _______________________________
7. Microscopic ___________________________
B. Complete blood picture and haemogram
8. Total count (Cells/Cu.mm) ______________________
9. Differential count: P ____ (%) L ____ (%) E ____ (%) M ____ (%) B ____ (%)
10. ESR (mm/ 1st hour) _______________
11. M.C.H.C. (g/dl) _______________
12. M.C.V. (fl) _______________
13. PCV (%) _______________
14. Hb (gm/dl) _______________
15. Serum iron (μg/dl) _______________
16. Total Iron Binding Capacity - TIBC (μg/dl) _______________
583
C. Plasma glucose (mg/dl)
17. Fasting _______________
18. Post prandial _______________
D. Lipid profile (mg/dl)
19. HDL _______________
20. LDL _______________
E. Liver function tests
21. Serum proteins (gm/dl) Albumin ________ Globulin_________
Serum bilirubin (mg/dl). Total ________ Direct____________
22. SGOT (IU/L) ______
23. SGPT (IU/L) ______
24. Serum alkaline phosphatase (U/L)
25. Serum triglycerides (mg/dl) _______________
26. Serum cholesterol (mg/dl) _______________
F. Serum electrolytes (mmol/L)
27. Sodium____________
28. Potassium _________
29. Chlorides __________
G. Renal function tests (mg/dl)
30. Blood urea _______
31. Serum creatinine __________
32. Serum uric acid (mg/dl) _________
33. Serum thyroid stimulating hormone (μU/ml) ____________
584
34. Serum calcium (mg/dl) ____________________
35. Serum phosphates (phosphorous) _________________
H. Special tests
36. ECG findings _______________________________
37. Pulmonary function test findings _____________________
I. Marker of inflammation
38. HsCRP (mg/L)_______________________________
39. TNF á (pg/ml) _______________________________
40. IL-6 (pg/ml) _________________________________
41. Serum melatonin (pg/ml) ________
J. Free radical system
42. Melonyl aldehyde
43. Catalase
44. Super oxide dismutase
45. Glutathione
46. Peroxidase
47. Prostate specific antigen ____________
48. Test for insulin resistance ___________
Date: _________________ Signature of the Investigator: ______________________
585
(To be translated in to local language)
Sl. No. of Subject _____________________________________________________________

Name of Subject ______________________________________________________________
(To be issued on 1st visit (0 day), 2nd visit (30th day), 3rd visit (60th day) and 4th visit (90th
day) and taken back on 2nd visit (30th day), 3rd visit (60th day), 4th visit (90th day) and 5th visit
(120th day))
Please come for next visit on ______________________________ (Date and time is to be
filled by the Investigator)
• Please take 5 gm of Ashwagandha churna (1 sachet) daily at 9 AM with water (approx.
150 ml.).
• Please take 5 gm of Triphala churna (1 sachet) daily at 9 PM with water (approx. 150
ml.).
• Please return the empty sachets after taking medicine along with the compliance report
form duly filled.
(5 gm of Ashwagandha churna) (5 gm of Triphala churna)
medicine medicine
1.
586
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
587
28.
29.
30.
Name of the participant _______________________________________________________
Date: _______________________________________________________________________
Signature or Thumb impression of the participant __________________________________
Signature of the Investigator with date ___________________________________________
588
RECEIPT
Received an amount Rs.100 (Rupees one hundred only) from_____________________________

__________(name) Institute/unit/center_____________________________________ (station) on
__________________________ (date) for visit no.____________________________________
Name of participant & Sl. No. __________________________________________________
Date: _______________
Signature or Thumb impression__________________________________________________
Signature of the Investigator with date ___________________________________________
Signature of Account’s Personnel /Office Personnel _______________________________
Signature of the Director/In charge ______________________________________________
589
Blank
590
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA
KALPA DRUGS IN HEALTHY ELDERLY PERSONS
Drug: Study Code:

AND SIDDHA
591
Blank
592
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA KALPA DRUGS IN
I. BACKGROUND
In Siddha system health is defined as a state of physical, mental, social and spiritual well
being, devoid of any degenerative disorders. Kayakalpa drugs ensure preventive aspects and also
the longevity. In Siddha system, elevation of man to attain the highest eternal bliss forever is
regarded as the highest form. Siddha’s Kaya Kalpa paved way for such highest form.
Kaya kalpa is divided into two main categories. One is Kalpa yogam and other is Kalpa
avizhtham. Eight types of yogic stages are described which helps in the elevation of man to a
supernatural being under kalpa yogam1.
Drugs which are capable of preventing as well as curing chronic and degenerative diseases,
and also used as rejuvenators in prolongation of life are called Kalpa avizhtham. Siddha system has
a unique way in the preparation of Kalpa drugs with particular specified herbs, minerals and
metals. It is divided into two categories. One is general and the other is special. The general kalpa
drugs are used in normal individuals aiming at promotion of strength, vitality and vigor, improving
memory and intelligence, immunity against disease and decay, preservation of youthfulness, lusture,
complexion and voice. The special kalpa drugs, which are used against chronic and degenerative
disorders specifically to eradicate various disease conditions and bring back the vigor and vitality
in the individuals.
II. OBJECTIVE
To evaluate the efficacy of herbomineral kayakalpa drugs in the promotion of positive
health in healthy volunteers.
III. CENTRES
References
1.
593
Drug : Nelli karpam (Nelli vattral powder + abiraga chendooram.
Dosage : Nelli vattral Powder 1 gm. Abiraga Chendooram 200 mg.with
honey twice a day.
Duration : 40 days.
Design of : Randomized double blind Placebo controlled study.
the study
Duration of : 40 days drug therapy with a follow up for 6 months without drug
the study
Period of : 220 days for each case. Total duration will be three years to
Study complete the trial at each Centre
Follow – Up : Two follow-up will be carried out after three months and after six
months of the completion of treatment
1. Age between 60 and 69 years.
3. Ambulatory and Co-operative.
1. Diabetes
2. Hypertension
3. Bronchial Asthma
4. Cancer
5. Manifest Cardiac ailment
6. AIDS
7. Jaundice
8. Kidney related diseases
9. Dementia Grade II & above
594
During the course of the trial treatment, if any serious condition develops which requires
urgent treatment such subjects may be withdrawn from the trial and managed by the Principal
the proforma (Forms I & IA). Clinical assessment will be done before preparatory regimen, at the
end of five weeks, 3rd month and 6th month during treatment and at the end of 3rd and 6th
month follow up (Form II). The laboratory investigations and the physiological parameters will be
recorded before drug administration, at the end of one month, at the end of treatment and at the
end of follow-up. [Form III]
Clinical symptoms, physiological parameters and laboratory parameters will be analyzed
using appropriate statistical methods.
X. CLINICAL ASSESSMENT
List of Clinical Symptoms to be taken into account for assessment using VAS (Visual
Analogue Scale): -
1. Dizzy spells/Giddiness
2. Breathlessness on exertion
3. Tremors
4. Constipation
5. Urgency to micturate
6. Aching muscles or joints
7. Pain/Stiffness in joints
8. Numbness
9. Abnormality in sleep
595
The progress of the trial will be monitored by CCRAS Headquarters, New Delhi. Data
analysis will be undertaken at Central Research Institute for Siddha, Chennai.
XII. ETHICAL REVIEW
Institutional Ethical Committee (IEC) should give clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form should be submitted alongwith
project proposal for approval by IEC. Both should be maintained in duplicate with one copy
given to the patient at the time of entry to the trial
XIII. TRAVEL LING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to subject.
596
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial of Nellikarpam – Nelli vattral powder 1 gm and Abbirga chendooram 200 mg.
twice a day with honey for 40 days on the general health of the Aged persons.

Relationship ___________________________________
597

Siddha has laid emphasis on maintenance of positive health and prevention of diseases,
besides management/treatment of diseases. Kaya kalpa Therapy of Siddha promotes health of
individual especially elderly persons. The present study is aimed to evaluate selected Siddha Kaya
Kalpa drugs for their efficacy in the promotion of health of elderly people. You are invited to
participate in this study where you will be provided a combination of Nelli vattral chooranam 1gm
and Abiraga chendooram 200 mg twice a day with honey for 40 days.
instructions scrupulously. The study will take approximately 32 weeks to complete (40 days for
treatment and another 24 weeks for follow-up study). During this period, you are expected to visit
the hospital 10 times. The interval between the 1st and second visit will be one week and second
and third visit will be around 10 days. Your next visit will be after one month. There will be five
more visits after every one-month of last visit.
If you were found eligible, you would be put on trial treatment for 6 weeks. The
daily dosage will be 1200mg twice. At each visit, you will be supplied with sufficient
quantities of drugs to last until your next visit.
598
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
7. Age between 60 and 79 years of either Sex
9. Ambulatory and Cooperative
10. Diabetes
11. Hypertension
12. Bronchial Asthma
13. Cancer
14. Manifest Cardiac ailment
15. AIDS
599
16. Jaundice
17. Kidney related diseases
18. Dementia (Score >25 on Mini Mental Examination

Scale & > one episode of depression or delirium)
19. Under treatment for any other serious illness
If admitted, Sr. No. of the Subject: ______________________________________________
No. of packets issued: ________________________________________________________
600
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA KALPA DRUGS
INHEALTHY ELDERLY PERSONS
1. Centre : ...................................
3. Sr. No. of the Subject : .......................................................................................................
4. Subject Name : ....................................................................................................................
7. Address : ..............................................................................................................................
10. Income (per capita per month in Rs.) : ................................................................................

of the participant and Head of the family
Living alone 1
601
Living with his/her spouse 2
Living with his/her family 3
Living in an old age home 4
Others (specify) 5
12. Income (per capita per month) of the participant and Head of the family
in Rs __________________________________________________________________
Chief complaint with duration (if any) Absent (0) Present (1) Duration
13. Constipation
14. Vague Pain
15. Fatigue
16. Dizziness
17. Weakness
18. Forgetfulness
Recurrent frequent attacks of: Yes (1) No (0)
19. Fever
If yes, indicate frequency of attack in months____________________________________
20. Rhinitis/upper respiratory tract infection
21. Urinary tract infection
22. Other complaints
If yes, specify: ___________________________________________________________
602
History of Past illness No (0) Yes (1)
23. Tuberculosis
24. Rheumatic fever
25. Major hospitalization/surgery during past three years
If yes, specify ___________________________________________________________
Personal History
27. Sleep Normal (1) Duration in hours______________________
Abnormal (2) Duration in hours______________________
If Abnormal specify Yes (1) No (0)
(a) Initiation:
(b) Maintenance:
(c) Freshness in the morning:
Yes (1) No (0)
28. Presence of anxiety
29. Constipation
Addiction Yes (1) No (0)
30. Smoking
31. Tobacco
603
32. Alcohol
33. Any other (specify)________________
Sannipataj
35. Height (cm) ______________
36. Weight (kg) ______________
37. Pulse (per min) ______________
38. Blood Pressure Systolic (mm Hg) ______________
39. Blood Pressure Diastolic (mm Hg) ______________
40. Body temperature (o F) ______________
41. Respiration rate ( per min) ______________
42. Anemia
43. Deformities
If present, specify _________________________________________________________
44. Lymphadenopathy
If present, specify: General (1) Local (2)
Area: __________________________________________________________________
604
If abnormal, details ____________________________________________
48. Vision
49. Hearing
605
CASE REPORT FORM III – CLINICAL ASSESSMENT AND PHYSIOLOGICAL
PARAMETERS
(0, 5 weeks, 3, 6, 9,12th months)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
Clinical Symptoms Visual Analogue Scale
9. Dizzy spells/Giddiness 0____________________________________10
10. Breathlessness on exertion 0____________________________________10
11. Constipation 0____________________________________10
12. Urgency to micturate 0____________________________________10
13. Aching muscles or joints 0____________________________________10
14. Low back or shoulder pain 0____________________________________10
15. All the symptoms for the clinical assessment are non-specific without any clinical illness to
account for.
16. Numbness 0____________________________________10
606
17. Tremors 0____________________________________10
18. Sleep Abnormality 0____________________________________10
19. Loss of Appetite 0____________________________________10
If yes, Present specify______________________________________________________
Continuing 1
Drop out 2 Reason: _____________________________
Died 3 Cause: ______________________________
24. Systolic blood pressure (mm of Hg) __________________
25. Diastolic blood pressure (mm of Hg) __________________
26. Upper mid arm circumferences (cm) __________________
27. Chest circumference (cm) __________________
Hand Grip
28. Left Hand (kg) __________________
29. Right Hand (kg) __________________
30. Weight (kg) __________________
607
31. Seated Stature (cm) __________________
32. Biacromial Diameter(cm) __________________
33. Skin fold thickness (mm) __________________
34. Pulmonary Function
FEV (L)_______ PEFR (L) ______ RV (L) ______ FVC (L) ______
Date: ______________ Signature of the Investigator: ________________
608
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
7. Address : Permanent postal Address with phone number and email if any.
..............................................................................................................................................
..............................................................................................................................................
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group ? Yes No.
1 2 3 4
Adverse
Experience
Date started
609
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
Relationship to study
medication
Unrelated-1
Possible-2
Probable-3
610
administration of the drug; or a known adverse reaction pattern of the suspected drugs
could have been produced by the patients clinical stage, intermittent illness, trauma, accidents
etc:
611
(0, 5 week, 6th and 12th month)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
8. Month Assessment : Initial 0 Ist month 1
6th month 2 12th month 3
11. TC (Cells/Cmm.)_____________________
12. DC: P (%)_______ L (%) _______ E (%)______ M (%)______ B (%) _______
13. Hb (g/dl) _______________
14. ESR (1st hour.)(mm) _______________
15. PCV (%) _______________
612
16. Blood Sugar – PP(mg./dl) _______________
17. S. Cholesterol (mg./dl) _______________
18. HDL (mg./dl) _______________
19. LDL (mg./dl) _______________
21. B. Urea (mg./dl) _______________
23. Uric acid (mg./dl) _______________
25. Albumin (gm./dl) _______________
26. Globulin (gm./dl) _______________
27. A/G Ratio _______________
28. Immunoglobulin levels (gm/dl)
Ig.G. _______ Ig. M. ________ Ig. A.__________
29. Acid Phosphatase (KA units) _______________
30. Alk. Phosphatase (KA units) _______________
31. Hair melanin content (gm%) _______________
32. Nail calcium (mg/100mg) _______________
33. E.C.G.: _________________________________________________________________
34. X-ray Chest: [ 0 Month only ] ______________________________________________
35. X-ray one knee joint [ 0 & 12th Month only ] ________________________________
36. Any other Remarks _______________________________________________________
613
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614
REPRODUCTIVE SYSTEM
SECTION - X
Blank
616
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL
OF AYURVEDIC HERBAL FORMULATION IN THE
TREATMENT OF MENOPAUSAL SYNDROME
Drug: Study Code:

AND SIDDHA
617
Blank
618
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
I. BACKGROUND
At Menopause, ovarian estrogen and progestogen production fall to low levels, which in
some women are associated with a series of signs and symptoms and physiological consequences
of sex steroid deficiency. Deficiency of estrogens may result in vasomotor manifestations such as
hot flushes, perspiration, palpitation and headache. The women may also suffer from urogenital
symptoms such as vaginal itching, vaginal dryness and psychological symptoms such as irritability
depression and insomnia. The symptoms described above are known as Menopausal Syndrome.
Available treatment modalities in Western System of Medicine have some limitations in offering a
comprehensive satisfactory solution to the problem. Hence there is always search for safe and
effective treatment modality which does not require expensive monitoring system besides better
compliance to the subjects1.
II. OBJECTIVE
To assess the efficacy of an Ayurvedic formulation in the management of Menopausal
Syndrome.
III. CENTRES
Sample Size: 100 patients at each Centre, 50 control and 50 trial cases
References
1. Dr. Nirmala Joshi (1999) Ayurvedic concept in Gynaecology,) 2nd Edition (1999), Published by
Chaukabha Sanskrita Pratisthana, Delhi, India.
2. Dr. P.V. Tiwari (1990) Stri Roga Part II 1st Edition Chaukhamba Orientalia, Delhi.
3. Dr. D.C. Dutta, Text book of Gynaecology, 5th Edition2009, Published by New central book
agency, Delhi
619
Drug – Aswagandha, Madhuyasti, Balamula, Saunf,Tila-50mg each and Jayanati beeja-
100mg
Dosage – 700mg –twice a day
Duration – 6 months
Design of the study – Randomized Double – blind Placebo controlled study
Duration of the study- 6 months drug therapy with a follow up for 3 months without
drug
Total period of study - 9 months. Total duration will be three years to complete the trial
at each Centre.
Follow – Up: One follow-up will be carried out after three months of the completion of
treatment
2. History of amenorrhoea for not less than 6 months
3. Score of 10 or more as per the CCRAS scoring of Menopasual Syndrome.
1. Age: Less than 40 years and more than 55 years
2. CCRAS Menopausal score less than 10
3. Organic lesions like tuberculosis, STD, Cancer, Liver and Kidney diseases
4. Surgical menopause
5. Established cases of any mental illness
7. Unexplained uterine bleeding
A patient may be withdrawn from the trial on account of the following
1. Development of any major ailment, side effects necessitating institution of new modalities of
treatment.
2. Worsening of symptoms.
620
3. Patient’s failure to report for follow-up or irregular medication [Missing 10 or More
doses]
the proforma (Forms I & IA). Clinical assessment will be done before drug administration, at the
end of 1st month, 2nd, 3rd, 4th, 5th and 6th month during treatment and at the end of 3rd
month follow up (Form II). The laboratory investigations i.e. Urine Examination, Stool
examination, TC, DC (P, L, E, M, B), Hb%, ESR (1st hour), PCV, Blood Sugar (PP), Lipid
Profile, B. Urea, S. Creatinine, Uric acid, Total proteins, S. Albumin, S. Globulin, A/G Ratio,
SGOT, SGPT, Pap Smear, Thyroid function tests (T3,T4,TSH) LH, FSH Prolactin, X-Ray Chest,
Transe Vaginal Sonography will be recorded before drug administration, at the end of treatment
and at the end of follow-up. [Form-III]
methods.
X. CLINICAL ASSESSMENT
List of Clinical Symptoms to be taken into account for assessment of the effect of the
treatment of Menopausal Syndrome.
SYMPTOMS SCORE
1. Hot flushes 5
2. Night Sweating 5
3. Insomnia 3
4. Muscle/Joint pain 3
5. Anxiety 2
6. Mood fluctuation 2
7. Irritability 2
8. Dryness/itching in Vagina 3
9. Altered sexual desire 1
10. Fatigue 2
11. Stress incontinence 2
Total 29
621
The progress of the trial will be monitored by field visits by Monitoring Unit of CCRAS.
And under Guidance of the Clinical Trial Monitor. Data analysis will be undertaken at the
Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
Each participating centre’s Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the project is initiated. Patient’s information sheet and
informed consent form should be submitted alongwith project proposal for approval by IEC/ Head
of the Institution. Both should be maintained in duplicate with one copy given to the patient at the
A consolidated amount of Rs…….../- per visit will be paid to subject.
622
SYNDROME
the patient.
Date: _______________ Signature Investigator ______________
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial of _______________________ on the Menopausal Syndrome.

Relationship ___________________________________
623
SYNDROME

Ayurveda has laid emphasis on maintenance of positive health and prevention of diseases,
besides management/treatment of diseases. The present study is aimed to evaluate selected
Ayurvedic drugs for their efficacy in the management of menopausal syndrome. You are invited to
participate in this study where you will be provided a combination of Aswagandha, Madhuyasti,
Balamula, Saunf, Tila and Jayanti beeja This formulation will be given to you in the dose of 700mg
twice daily. Classical Texts of Ayurveda prescribe use of these drugs in various Gynecological
disorders. The previous observations in clinical and experimental studies have shown promising
effect of these drugs in the management of menopausal syndrome. About 300 healthy women from
this and other hospitals around the country will be taking part in this study.
instructions scrupulously. The study will take approximately 36 weeks to complete (24 weeks for
treatment and another 12 weeks for follow-up study). During this period, you are expected to visit
the hospital eight times. The interval between the first and subsequent visits during the six month
of treatment will be four weeks. After completion of treatment, status of Health will be monitored
for next three month after which you will be required to visit the hospital for necessary check up
physical examination. An X-ray, Blood and urine samples will also be taken. This is to make sure
that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 24 weeks. At each visit,
624
SYNDROME
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
2. History of amenorrhea for not less than 6 months
3. CCRAS Menopausal Syndrome Score>=10.
5. History of amenorrhea <6 months
6. Organic lesions like tuberculosis, STD,
7. Cancer, Liver and Kidney diseases
8. CCRAS Menopausal score < 10
9. Surgical menopause
625
10. Established cases of mental disorder
12. Unexplained uterine bleeding
If admitted, Sr. No. of the Subject: ____________________________________________
No. of packets issued: ____________________________________________
Date: ___________ Signature of the Investigator: ___________________
626
SYNDROME
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
7. Address : ..............................................................................................................................
Constant sitting/standing for long hour
10. Family income per month in Rs. : ........................................................................................
11. Total family members : .........................................................................................................
627
12. Marital status: Single Married Separated
Window Widower
Living alone
Living with spouse/nuclear
Living in joint family
Others (specify)
Chief complaint with duration in weeks (If any) Absent (0) Present (1) Duration
14. Hot flushes
15. Night Sweating
16. Insomnia
17. Muscle/Joint pain
18. Anxiety
19. Mood fluctuation
20. Irritability
21. Dryness/itching in vagina
22. Altered sexual desire
23. Fatigue
24. Stress incontinence
25. Other complaints
If any, specify: ___________________________________________________________
26. History of serious illness in the past (if any): ____________________________________
628
Personal History
27. Diet Veg. 1 Non-Veg. 2 Lacto-Ova Veg. 3
28. Sleep Good. 1 Disturbed 2 Insomnia 3
30. Bowel habit Regular 1 Constipation 2 Hard Stool 3
Loose Stool 4
Addiction
31. Smoking Yes 1 No 2
If yes specify: (a) Quantity [packs]: ________________
32. Tobacco Yes 1 No 2
If yes specify: (a) Quantity: ________________
33. Alcohol Yes 1 No 2
If yes specify: (a) Quantity (in ml/day): ________________
34. Any other (specify) _______________________________________________________
Menstrual History:
35. Age in years at Menarche
36. Duration of menstrual period in days
37. Interval of menstrual period
38. Age in years at onset of menopause
629
Obstetrics History:
39. Age at marriage
40. Parity (Number of Live births)
41. Duration in years since last delivery
Vata-Kaphaj Vata-Pittaja Pittaj-Kaphaja
Sannipataj
43. Height (cm) ____________
44. Weight (kg) ____________
45. Pulse (per min) ____________
46. Blood Pressure Systolic (mm Hg)____________
47. Blood Pressure Diastolic (mm Hg)____________
49. Pallor
50. Hirsutism
51. Lymphadenopathy
If present, specify
General Local Area: ______________________
52. CVS
If abnormal details________________________________________________________
630
54. CNS
57. Per vaginal examination
If abnormal, details________________________________________________________
58. Breast examination
59. Pap smear
Date: ____________ Signature of Investigator: ___________________
631
SYNDROME
FORM III – CLINICAL ASSESSMENT
(0, 1, 2, 3, 4, 5, 6 & 9th Month)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
9. Address : ..............................................................................................................................
Clinical Symptoms Abscent (0) Present (1)
10. Hot flushes
11. Night Sweating
12. Insomnia
13. Muscle/Joint pain
14. Anxiety
15. Mood fluctuation
16. Irritability
17. Dryness/itching in vagina
632
18. Altered sexual desire
19. Fatigue
20. Stress incontinence
21. Other complaints, if any (Specify) ____________________________________________
22. Adverse reaction: No 0 Yes 1
If yes, details:____________________________________________________________
Improved No change 2 Deteriorated 3
Complete Cure Improved 2 No Change 3
Deteriorated
Continuing
Drop out Reason:_____________________________
Died 3 Cause:_______________________________
Date: ______________ Signature of the investigator: ________________
633
SYNDROME
(0, 1, 2, 3, 4, 5, 6 & 9th Month)
1. Name of the Subject: ………………………………………….......................……....…

2. Address ……………………………………………………………..............…………..
3. Sr. No. of the subject:
4. Centre…………………………
6. Sex: Male (1) Female (2)
7. Date of Birth: Age (in yrs.):
8. Date of admission: Date of discharged:
9. Address : ................................................................................................................................
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group? Yes No
1 2 3 4
Adverse
Experience
634
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3

Serious*
Yes-1
No-2

635
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
636
SYNDROME
( 0, 6th AND 9th MONTH)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
8. Address : ..............................................................................................................................
9. Month Assessment : Initial 0 6th month 1
9th month 2
12. TC (Cells/Cmm.)_____________________
13. DC: P (%) ______ L (%) ______ E (%) ______ M (%) _______ B (%) _______
14. Hb (g/dl) _________________
637
15. ESR (1st hour.) (mm) _________________
16. PCV (%) _________________
17. Sugar – PP(mg./dl) _________________
18. S. Cholesterol (mg./dl _________________
19. HDL (mg./dl) _________________
20. LDL (mg./dl) _________________
21. S. Triglycerides (mg./dl) _________________
22. B. Urea (mg./dl) _________________
23. S. Creatinine (mg./dl) _________________
24. Uric acid (mg./dl) _________________
25. Total proteins (gm./dl) _________________
26. Albumin (gm./dl) _________________
27. Globulin (gm./dl) _________________
28. A/G Ratio _________________
29. SGOT _________________
30. SGPT _________________
The tests from S. No. 31 to 36 will be carried out only once at 0 month.
Thyroid Function test
31. T3 (n mol/L) __________________________________
32. T4 (ug/dL) __________________________________
33. TSH (mU/L) __________________________________
34. LH (IU/L) __________________________________
35. FSH (IU/L) __________________________________
638
36. Prolactin (ug/L) __________________________________
37. Trans Vaginal Sonograph __________________________________
38. Pap smear __________________________________
39. X-ray Chest: [0 Month only ] ______________________________
40. Any other Remarks __________________________________
41. Systolic blood pressure(mm of Hg) __________________
42. Diastolic blood pressure(mm of Hg) __________________
43. Weight (kg) __________________
Date: _____________ Signature of the investigator: ________________
639
SYNDROME
CASE RECORD FORM – V RECORD OF UNSCHEDULED VISITS OF THE
PATIENT
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
7. Date of unscheduled visit :
8. Address : ..............................................................................................................................
9. Summary of treatment given : ..........................................................................................

..........................................................................................
..........................................................................................
Date: _____________ Signature of the investigator: ________________
640
TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF
DYSFUNCTIONAL UTERINE BLEEDING
Drug: Study Code:

AND SIDDHA
641
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642
PROTOCOL TO STUDY THE EFFICACY OF AYURVEDIC FORMULATION IN
THE TREATMENT OF DYSFUNCTIONAL UTERINE BLEEDING
I. BACKGROUND
Dysfunctional Uterine Bleeding (DUB) is excessive or prolonged bleeding during menstrual
period. In addition, it also includes the menstruation with short inter menstrual period, for which no
demonstrable cause is found. Though no active reproductive age is exempt, the disease is mostly
found in early puberty and or late reproductive life (peri-menopausal period). Modern Medicine
does not have a permanent cure and most of the time patients have to opt for hysterectomy.
Rakta Pradara or Asragdhara mentioned in Ayurved is a broad term which covers all sorts of
excessive uterine bleeding. For the present study, exclusively dysfunctional uterine bleeding has
been taken up. Ayurvedic system is having many effective remedies for this problem. Among them
the combination of Ashoka- 100mg., Lodhra –50mg., Nagakeshara-50mg.,Doorva-100mg are
selected for the present study. The previous observations in clinical and experimental studies have
shown promising effect of these drugs in the management of DUB.
II. OBJECTIVE
To assess the efficacy of an Ayurvedic formulation in the management of Dysfunctional
Uterine Bleeding (DUB).
III. CENTRES
CCRAS identified Centres.
Treatment : Two capsule of 300mg each containing Ashoka and
Doorva (two parts each), Lodhra and Nagakeshara (one
part each) twice a day, for three months.
Duration : 3 months.
Duration of the study : Three months drug therapy with follow up for six months.
Total period of study will be nine months for each case.
Period of Study : 9 months for each case. Total duration will be three years
to complete the trial at each Centre.
643
Follow – Up : Two follow-ups will be carried out after three and six
month of the completion of treatment.
1. Age: between menarche and menopause
2. Excessive bleeding during menstruation (change of more than 5 soiled pads in a day)
3. Passing of large clots
4. Prolonged menstrual bleeding (more than 7 days)
5. Excessive bleeding for more than 2 consecutive cycles
1. Blood dyscrasias
2. Intrauterine growth such as myoma, endometrial polyp etc.
3. Cancer of cervix and or uterus
4. Hb% less than 7 gm.
5. Endocrinal disorders
6. Any other systemic disorders likely to influence menstrual cycle
7. Case undergoing treatment for any other serious illness.
The patients will be withdrawn from the study
1. If the condition worsens
2. Development of any other serious disease
3. Patient’s failure to report for follow-up or irregular medication [Missing 10 or More Doses]
The cases withdrawn from the study will be managed by the Investigator
end of 1st, 2nd and 3rd month, during treatment and at the end of 6th and 9th month during follow
up (Form II). Required laboratory investigations will be carried out to exclude cases as specified
in the criteria for exclusion (Form-III).
644
IX. CRITERIA FOR ASSESSMENT OF RESULTS
Reduction in menstrual flow (i.e. decrease in use of soiled pads (three or less) in a day),
total stoppage of passing of large clots and reduction in menstrual bleeding period to 7 days or
less will be considered as significant improvement.
Data on number of pads used, duration of flow of menstrual period and Disappearance of
large clots will be tabulated and analyzed using appropriate statistical methods.
The progress of the trial will be monitored by field visits by Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
will report immediately to the PI and Data Monitoring Board for any life threatening
written and approved for the treatment of study related adverse events
A consolidated amount of Rs. ______ per visit will be paid to subject put on treatment.
personnel involved in the trial at CCRAS Hqrs. The investigators and technicians will be detailed
645
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
the patient.
Name: ____________________________
CONSENT BY SUBJECT
in the clinical trial assessment of the effect of Ayurvedic formulation in the treatment of
dysfunctional uterine bleeding.

Relationship ___________________________________
646
BLEEDING

Dysfunctional Uterine Bleeding (DUB) is excessive or prolonged bleeding during menstrual
period, for which no demonstrable cause is found. Ayurveda is having many effective remedies for
this problem. A formulation containing Ashoka and Doorva (two parts each), Lodhra and
Nagakeshara (one part each) have been selected for the present study.
instructions scrupulously. The study will take nine months to complete (three months for treatment
and another six months for follow-up study). During this period, you are expected to visit the
hospital eight times. The interval between the first and subsequent visits during the three months of
treatment will be one month. After completion of treatment, status of health will be monitored for
next six months during which you will be required to visit the hospital for necessary check up after
three and six months.
physical examination. An ultra sound will be done and Blood and urine samples will also be taken.
This is to make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 6 months. At
each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit.
647
BLEEDING
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
1. Age: between menarche and menopause
2. Excessive bleeding during menstruation

(use of more than five soiled pads)
4. Prolonged menstrual bleeding (more than seven days)
5. Blood dyscrasias
6. Intrauterine growths
7. Cancer of cervix and or uterus
8. Hb% < 7 gms.
9. Endocrinal disorders
10. Any other systemic disorders likely to influence

menstrual cycle
648
11. Case undergoing treatment or any other serious illness_____________________________
If Sl. No. 1 – 47 is ‘Yes’ and Sl. No.5 – 16 are ‘No’
If admitted, Sr. No. of the subject: _____________________
No. of packets issued: ______________________________
Dated: ____________ Signature of the Investigator: _____________________
649
SYNDROME
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
7. Address : ..............................................................................................................................
Constant sitting/standing for long hour 5
10. Family income per month in Rs. : ........................................................................................
11. Total family members : .........................................................................................................
650
Chief complaint with duration in months Absent (0) Present (1) Duration
If present, indicate since when (in months) _____________________________________
Number of soiled pads being used per day ____________________________________
If present since when (months)_______________________________________________
Number of clots per day___________________________________________________
14. Prolonged menstrual (more than seven days)
If present since when (months) ______________________________________________
Duration of bleeding in days_________________________________________________
Pain during Menses________________________________________________________
15. Other complaints, if any (Specify with duration) _________________________________
Personal History
16. Diet: Veg. 1 Non-veg 2
17. Bowel habits Regular 1 Irregular 2
Past Menstrual History:
18. Age at Menarche (in years)
19. Average length of menstrual cycle in days
20. Duration of bleeding period in days
21. Amount of bleeding per day (in pads)
22. Associated symptoms if any_________________________________________________
21. History of excessive bleeding in the past: Yes 1 No 2
If yes give details including treatment received: _________________________________

_________________________________
651
Obstetric History:
22. Marital status: Unmarried 1 Married 2 Widow 3
Divorce/ 4
Separated
If married Age at marriage (In years):
23. Total no. of pregnancies
24. H/o difficult labour
25. No. of living children
26. Total no. of Abortion/still birth if any
27. Age of last child (in years)
28. Current Contraceptive use if any
None IUD Condom Vasectomy
Natural Pills Female sterilization
29. Prakriti (Pl. see separate sheet attached):
Sannipataja 7
30. Pulse (per min) ____________
31. Blood Pressure Systolic (mm Hg) ____________
32. Blood Pressure Diastolic (mm Hg) ____________
652
34. Hirsutism
35. Lymphadenopathy
If present, specify the area__________________________________________________
Local 1 General 2 Area __________________________________
36. CVS
38. CNS
PER VAGINAL EXAMINATION (only in married woman)
41. Uterine size: Normal 1 Enlarged 2
If enlarged, size in cms. ____________________________________________________
42. Uterine mobility: Free 1 Restricted 2 Fixed 3
43. Uterine tenderness Yes 1 No 2
44. Adnexa Normal 1 Thickened and tender 2
45. Adnexal mass Absent 1 Present 2
46. Tenderness in lower abdomen Yes 1 No 2
653
47. PER SPECULUM EXAMINATION (only in married woman)
Normal 1 Abnormal 2
If Abnormal, Specify_______________________________________________________
Cervical examination Normal (1) Abnormal (0)
48. Cervicitis
49. Erosion
50. Mucous discharge
51. Polyp
52. Ectropion of Others_______________________________________________________
53. Breast examination
Dated: ________________ Signature of Investigator: ___________________
654
BLEEDING
CASE REPORT FORM III – CLINICAL ASSESMENT
(0, 1st, 2nd, 3rd, 6th and 9th Month)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
8. Month of Assessment : Initial 1st month 2nd month
3rd month (3) 6th month 9th month
9. Address : ..............................................................................................................................
Clinical Symptoms Abscent (0) Present (1)
If present number of pads used per day_______________________________________
12. Prolonged menstrual bleeding
If present duration of MF in days____________________________________________
13. Pain during menses Yes 1 No 2
14. Other complaints, if any (Specify)_____________________________________________
655
Continuing (1)
Drop out (2) Reason:______________________________
Died (3) Cause:_______________________________
.Date: ______________ Signature of the Investigator ________________
656
BLEEDING
CASE REPORT FORM IV– LABORATORY INVESTIGATIONS PARAMETERS
(For exclusion of cases at the time of screening)
1. Centre : ...................................
4. Subject Name : ....................................................................................................................
8. Month of Assessment : Initial 1st month 2nd month
3rd month (3) 6th month 9th month
Routine ____________________ Microscopic___________________________
11. TC (Cells/Cmm)___________________________________________________
12. DC: P (%) ______ P (%) ______ P (%) ______ P (%) ______ P (%) ______
13. Hb (g/dl) ______________
14. ESR (1st hour.) (mm) ______________
15. Bleeding time ______________
Dated: ________________ Signature of Investigator/___________________
657
(Investigations from Sl.No.16 to 24 will be done initially only)
16. Clotting time: ____________________________
17. Prothrombin Time: ____________________________
18. Fibrinogen count: ____________________________
19. PCV (%): ____________________________
20. Blood Sugar – PP (mg./dl): ____________________________
21. B. Urea (mg./dl): ____________________________
22. S. Creatinine (mg./dl): ____________________________
23. Thyroid function tests: ____________________________
i. T3 ____________________________
ii. T4 ____________________________
iii. TSH ____________________________
iv. LH ____________________________
v. FSH ____________________________
24. Transe Vaginal Sonography ___________________________________________
25. Any other Remarks ___________________________________________
Date: _____________ Signature of Investigator: _________________________
658
RAJAHPRAVARTINI VATI IN KASHTARTAVA
(DYSMENORRHOEA)
Drug: Study Code:

AND SIDDHA
659
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660
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
I. BACKGROUND
Dysmenorrhoea (Kashtarthava/udavarta)1 is characterized by severe pelvic pain
occurring before or during the menstruation. Headache, nausea, vomiting, diarrhoea, lethargy,
dizziness, sweating, breast tenderness, tachycardia and heavy menstrual flow may accompany this
pain. It is classified into two, primary and secondary dysmenorrhoea. Primary Dysmenorrhoea has
no organic cause, starts usually during teenage years and coincides with the onset of ovulatory
cycles. An overall 75% of women develop Primary Dysmenorrhoea of them 15% may have
severe symptoms. Secondary Dysmenorrhoea usually arises in later reproductive age and usually
is the result of pelvic pathology.
Woman with primary dysmenorrhoea usually has regular menstrual cycles with symptoms
beginning just prior to menstruation. In the patients of dysmenorrhoea uterine contraction pressure
and resting tone are increased. The pain is thought to be secondary to ischemia due to reduction
in blood flow, which accompanies the contractions.
Secondary Dysmenorrhoea result from pelvic pathology and can occur at any age after
menarche and before menopause. Cervical Stenosis, Endometriosis, Pelvic infections, Pelvic
congestion, intrauterine birth control devices etc. can cause secondary Dysmenorrhoea.
In Ayurveda, the cardinal feature of Udavartha Yonivyvapath is said as pain during
menstruation. Based on the cardinal feature and other associated features like low back pain,relief
from pain after discharge of menstrual blood clot etc, this can be compared with primary or
secondary dysmenorrhoea. For the present study primary dysmenorrhoea cases only will be
included. To regulate uterine contractions and uterine tone many effective Ayurvedic regimen are
described in Ayurvedic classics. On clinical and experimental studies these drugs are also found
effective. For the present study Rajahpravartini vati, a well known and safe classical
Ayurvedic drug has taken up for the study.
References
1. Ambikadutta Shastri, 1972, Sushruta Samhita, Ayurveda tatwa pradeepika, Hindi Commentary,
Chowkamba Sanskrita Series, Varanasi.
2. Priyavat Sharma - Dravyaguna Vignana, Chowkamba Sanskrita Series, Varanasi.
3. Vagbhata, 1976 Astanga Samgraha, Sutra sthana, Telugu Academy, Hyderabad.
4. Ayurvedic formulary of India, Part-1, Department of AYUSH, Ministry of Health & Family
Welfare, Government of India
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Owing to the gravity of the situation, need is felt for search of safe/effective Ayurvedic oral
dosage forms to reduce pain during menstrual period. Keeping the gravity of the situation and the
public health needs in view, the council intends to initiate scientific studies on well known and safe
classical Ayurvedic formulation Rajahpravartini vati, which is being successfully prescribed by
Ayurvedic physicians without any side effects since centuries. The formulation has been
standardized after formulating SOPs besides safety / toxicity evaluation.
The objective of current study is to assess clinical safety and efficacy through measurable
objective parameters.
II. OBJECTIVES
1) To observe the effect of Rajahpravartini vati in the management of menstrual pain of
dysmenorrohoea subjects.
2) Observe the clinical safety of on Rajahpravartini vati in dysmenorrohoea Subjects
III. CENTRES
S. No. Institutes/ centers/ units

1. ALARCA,Chennai
2. RRI (A), Trivendrum
3. RRI (A), Jammu
4. RRI(A), Bangalore
5. IADR, Ahamedabad
6. CRI(A), Jaipur
7. CRI(A), Bhubaneshwar
8. CRI(P), Cheruthurthy
9. CRI(A), New Delhi

Trial Drug /Dosage /Duration : Rajahpravartini vati 250 mg. (tablet) twice
daily after meal with warm water for 90
days (for three consecutive cycles)
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The drug will be started from 5th day of
the menstrual cycle
Design of the Study : Open trial
Total period of the study : 1 year (recruitment of Subjects upto the
end of 6th month, continuation of trial
therapy till end of 8 th month, last 4
months for compilation of data and
statistical analysis)
1. Age between 16-35 years.
2. Painful menstruation for at least 3 consecutive cycles with regular menstrual cycles having
normal bleeding phase. (21- 35 days is the normal menstrual cycle)
3. Not associated with any organic Reproductive system abnormalities (Excluded clinically
and Radiological)
1. Cases of Secondary dysmenorrhoea
2. Pain abdomen associated with Excessive Bleeding Per vagina
3. Associated with leomyoma (Fibroid) of Uterus, Ovarian Cyst, Endometriosis (Excluded
Clinically and Radiological)
4. Associated with pelvic inflammatory disease, Hydrosalpinx (Excluded Clinically and
Radiological)
5. Associated with any serious systemic disorders likely to influence menstrual cycle
6. History of malignancy of pelvic organs
7. History of Hypo and Hyper Thyroidism
8. Women using an IUD/ Oral Contraceptive Pills (OCP)
10. Hypertension
events which requires urgent treatment or if patients herself want to withdraw from the study, such
663
recorded as per case record form I & II. Clinical, physiological and Laboratory assessment in
form III at 0, 30th (5th day of menstruation), 60th (5th day of menstruation) and 90th day (5th day
of menstruation) and laboratory investigations in forms IV will be done at 0 and 90th days.
The changes in the subjective and objective parameters before and after the treatment shall
be considered for assessment of the safety and efficacy the drug. The safety parameters (liver and
kidney function) will be assessed at 0 and 90th day.
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at Hqrs
will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in
immediately to the PI and Data Monitoring Board for any life threatening conditions
whether they are perceived to be study related or not. The Board decides whether the
adverse effects warrant discontinuation of the study protocol. Protocols will be written and
approved for the treatment of study related adverse events
A consolidated amount of -------- per visit i.e., on the 1st day of recruitment after
screening, 1st, 2nd, 3rd month (4 times)
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The Laboratory Investigations (Haematological /Biochemical, etc.), which are not available
665
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “MULTICENTRIC OPEN CLINICAL TRIAL OF
RAJAHPRAVARTINI VATI IN KASHTARTAVA (DYSMENORRHOEA)”

Relationship ___________________________________
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Dysmenorrhoea is characterized by severe pelvic pain occurring before or during the
menstruation. Headache, nausea, vomiting, diarrhoea, lethargy, dizziness, sweating, breast
tenderness, tachycardia and heavy menstrual flow may accompany this pain. It is classified into
two, primary and secondary dysmenorrhoea. Primary Dysmenorrhoea has no organic cause, starts
usually during teenage years and coincides with the onset of ovulatory cycles. An overall 75% of
women develop Primary Dysmenorrhoea of them 15% may have severe symptoms. Secondary
Dysmenorrhoea usually arises in later reproductive age and usually is the result of pelvic pathology.
In conventional medicine various forms of pain killers and anti spasmodic drugs are
commonly prescribed, but these therapies have their noted adverse effects e.g. nausea, vomitting,
abdominal pain.
Owing to the gravity of the situation, need is felt for search of safe/effective Ayurvedic oral
dosage forms to reduce pain during menstrual period. Keeping the gravity of the situation and the
public health needs in view, the council has initiated scientific studies on Rajahpravardhini vati, a
promising formulation that is being successfully prescribed by Ayurvedic physicians without any side
effects since centuries. The formulation has been standardized after formulating SOPs besides safety
/ toxicity evaluation.
The objective of current study is to assess clinical safety and efficacy through measurable
objective parameters.
instructions scrupulously. The study will take approximately 3 months during treatment period, you
are expected to visit the hospital 3 times i.e. on 0, 1st, 2nd, 3rd month for clinical and physiological
assessment.
during the treatment period, this should be noticed to the Principle Investigator.
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BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
6. Age between 16-35 years.
7. Painful menstruation for at least 3 consecutive cycles

with regular menstrual cycles having normal bleeding phase.
8. (21- 35 days is the normal menstrual cycle) abnormalities

(Excluded Clinically and Radiological)
9. Not associated with any organic Reproductive system
CRITERIA OF EXCLUSION Yes (1) No (2)
10. Cases of secondary Dysmenorrhoea
11. Pain abdomen associated with Excessive BPV
12. Associated with leomyoma of Uterus, Ovarian Cyst,

Endometriosis (Excluded Clinically and Radiological)
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13. Assoicated with pelvic inflammatory disease, Hydrosalpinx
14. Associated with any serious systemic disorders likely to

influence menstrual cycle
15. History of malignancy of pelvic organs
16. History of Hypo and Hyper thyroidisam
17. Women using an IUD/ Oral Contraceptive Pills (OCP)
19. Hypertension
Whether the subject is suitable for enrollment? YES NO
(A subject is suitable for enrollment in the trial, if points 6 to 9 are YES and points 10
to 19 are NO)
If enrolled:-
Subject Sl. No.: ___________ No. of strips issued_________________
Date: ___________________
20. Irregular follow-up
21. Not 100% compliance with treatment
22. Developing any other serious illness during treatment
If ‘Yes’ to 6 – 9 and ‘No’ to 10 – 19 above, recruit the subject for the trial, if recruited, subject
serial No: _ _ _ _ _ _ _ _ _ _ _ _
Date: _________________ Signature of the investigator: ______________________
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1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................
SOCIO ECONOMIC BACKGROUND:
1). Education:
Husband: 1.Nil 2. Upto Primary 3.Upto middle
4. Upto 10+2 5. College & Above
Wife: 1. Nil 2. Upto Primary 3.Upto middle
2). Occupation: Husband: _______________________ Wife: ________________________
3). Family Income per month in Rs: ______________ Income per capita in Rs: __________
4). Religion: 1. Hindu 2. Muslim 3. Sikh
4. Christian 5. Others
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5). Working Status: 1. Not gainfully employed 2. Casual worker
3. Own business 4. Regular salaried job
6). MEDICAL HISTORY:
Chronic illness: Allergy:
Surgery: Communicable diseases
7). FAMILY HISTORY:
1). Type of family: Nuclear No. of persons:
2). Diseases: Chronic illness:
Hypertension: Diabetes:
Genetic disorders: specify: ____________________
Psychiatric disorder: Other:
3). History of Multiple births: ___________________________________________________
8). MENSTRUAL HISTORY:
1. Menarche:
2. Menstruation - Duration: Flow:
- Interval: Amount: (Number of pads)
- Passage of clots: yes/no
9). MARITAL HISTORY:
1. Age of marriage: 2. Marital life (in years):
3. Consanguineous: Yes/No
4. Current contraceptive use (If any): IUCD OCP Female sterilization
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10). PERSONAL HISTORY:
1. Diet: Vegetarian: Non-Vegetarian:
2. Habits: Smoking/Drinking/Chewing Pan/Tobacco:
11). OBSTETRIC HISTORY:
S.N Year Full Pre Post Abortion Type of Baby

term term term Sex Alive Stillborn Weight
12). HISTORY OF PRESENT COMPLAINTS Yes (1) No (0) Duration

(in days)
1. Pain abdomen
2. Low backache
3. Pain in lower limbs
4. Nausea & vomiting
5. Constipation
6. Giddiness
7. Breast tenderness
8. Diarrhoea
9. Headache
10. Fainting
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Medication:
1). Whether received any hormonal treatment previously
2). Any other medication
3. Body weight (Kg.) __________
4. Height (cm)_________
5. Body temperature (oF)____________
6. Blood pressure (in sitting posture of right upper limb) –
7. Systolic _______ mm/Hg
8. Diastolic _______ mm/Hg
9. Pulse rate__________ /min. (Radial pulse of right upper limb)
10. Respiration rate _________ /min.
11. Pallor
12. Koilonychia
13. Lymphadenopathy
14. CVS with chest
If Abnormal, specify abnormalities____________________________________________
15. CNS
If abnormal, specify abnormalities_____________________________________________
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16. DIGESTIVE SYSTEM
Liver
Spleen
Yes (1) No (0)
Inspection: Incisional Scars:
Over stretching of abdomen:
Prominent veins over the abdomen:
Palpation: Tenderness in lower abdomen:
18. Pelvic Examination
• Inspection – Perineum Vulva:
• Per speculum examination: Vagina:
• (in married woman): Cervix:
• Bimanual examination (in married woman):
Uterus – Size Position Mobility Tenderness
Adnexa – Palpable / Not palpable Tenderness Adnexal mass
17. SAMPRAPTI (PATHOGENESIS) Vata Pitta Kapha
a) Anubandhya dosha
b) Anubandha dosha
c) Avaraka dosha
d) Kasheena dosha
e) Ksheena dhatu Rasa Rakta Mamsa
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Meda Asthi Majja
Shukra Oja
f) Dushya Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Oja
Date: _____________ Signature of investigator ___________________
Name of investigator ______________________
675
CASE REPORT FORM – III
PERIODICAL OBSERVATION AND CLINICAL ASSESSMENT
(On 0 Day, 5th day of menstruation)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................
HISTORY OF PRESENT COMPLAINTS Yes (1) No (0) Duration

(in days)
1). Pain abdomen
2). Low backache
3). Pain in lower limbs
4). Nausea & vomiting
5). Constipation
6). Giddiness
7). Breast tenderness
8). Diarrhoea
676
9). Headache
10). Fainting
11) Other associated symptoms
If yes, specify____________________________________________________________
Date: ______________ Signature of investigator ___________________
677
CASE REPORT FORM III
(1st month, 5th day of menstruation)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................

(in days)
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
8. Diarrhoea
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9. Headache
10. Fainting
11. Other associated symptoms
If yes, specify____________________________________________________________
Adverse reactions: Present Absent
13. Nausea
14. Diarrhoea
15. Skin rashes
16. Any other adverse complaints/ observations specify ______________________________
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
If continuing Number of blisters issued _____________________________
679
(2nd month, 5th day of menstruation)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................

(in days)
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
8. Diarrhoea
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9. Headache
10. Fainting
If yes, specify____________________________________________________________
13. Nausea
14. Diarrhoea
15. Skin rashes
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
681
(3rd month, 5th day of menstruation)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................

(in days)
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
8. Diarrhoea
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9. Headache
10. Fainting
If yes, specify____________________________________________________________
13. Nausea
14. Diarrhoea
15. Skin rashes
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
683
(On Day 0)
CASE REPORT FORM – IV PERIODICAL OBSERVATION AND
LABORATORY ASSESSMENT
CCRAS MCT : 09 - 1
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................
7. Investigations: Blood:
1). Hb%: _____________________
2). ABO Rh: _____________________
3). VDRL _____________________
4). Clotting time _____________________
5). Bleeding time _____________________
6). Prothrombin time _____________________
7). Fibrinogen time _____________________
8). PCV (%) _____________________
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9). Blood Sugar PP _____________________
10). Blood Urea _____________________
11). Serum Creatinine _____________________
12). SGPT _____________________
13). SGPT _____________________
14). Serum Bilirubin _____________________
15). Thyroid profile (T3, T4 and TSH)
16). Serum Cholesterol
17). Urine: Routine: _____________________
Microscopic: _____________________
18). USG _____________________
Date:___________________ Signature of the investigator_________________
685
(On 90th Day)
CASE REPORT FORM – IV PERIODICAL OBSERVATION AND
LABORATORY ASSESSMENT
CCRAS MCT : 09 - 1
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
..............................................................................................................................
..............................................................................................................................
1). Hb%: _____________________
2). ABO Rh: _____________________
3). VDRL _____________________
4). Clotting time _____________________
5). Bleeding time _____________________
6). Prothrombin time _____________________
7). Fibrinogen time _____________________
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8). PCV (%) _____________________
9). Blood Sugar PP _____________________
10). Blood Urea _____________________
11). Serum Creatinine _____________________
12). SGPT _____________________
13). SGPT _____________________
14). Serum Bilirubin _____________________
15). Thyroid profile (T3, T4 and TSH)
16). Serum Cholesterol
17). Urine: Routine: _____________________
Microscopic: _____________________
18).USG _____________________
Date:___________________ Signature of the investigator_________________
687
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
(To be translated into local language)
Sl. No. of Participant .................................................................................................................

Please come for next visit on ................................. (Date and time is to be filled by the
Investigator)
• Please take one tablet twice a day after food with a glass of Luke warm water
• Please return the empty strip after taking medicine along with the compliance report
duly filled.
medicine medicine
1.
2.
3.
4.
5.
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6.
7.
8.
9.
10.
11.
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18.
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24.
25.
26.
27.
28.
29.
30.
689
(To be issued on 2nd visit – 31 day and taken back on 3nd visit –60th day)

Investigator)
duly filled.
medicine medicine
1.
2.
3.
4.
5.
690
6.
7.
8.
9.
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Investigator)
duly filled.
medicine medicine
1.
2.
3.
4.
5.
692
6.
7.
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RECEIPT
Received an amount Rs.100 (Rupees one hundred only) from__________________ (name)

Institute/unit/center________________ (station) on ___________________________ (date)
for visit no.__________________________________________________________________
Date: ____________ Name of participant & Sl. No. _________________________
Signature or Thumb impression________________________
Signature of the Investigator with date: _________________
Signature of Account’s Personnel /Office Personnel ________________________________
Signature of the Director/In charge ______________________________________________
694
OBSERVATIONS
1. Centre : ...................................
3. Patient No. : ............................................................................................................................
4. Name ......................................................................................................................................
5. Sex : Male Female
6. Age (in yrs). ..........................................................................................................................
VISUAL ANALOGUS SCALE FOR PAIN ASSESSMENT
Pain VAS Should be done at base line, each cycle
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MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINIVATI IN
KASHTARTAVA CDYSMENORRHOEA (IRON DEFICIENCY ANAEMIA)
OBSERVATIONS
1. Centre : ...................................
3. Patient No. : ............................................................................................................................
4. Name ......................................................................................................................................
5. Sex : Male Female
6. Age (in yrs). ..........................................................................................................................
Sl Subjective/ objective 0 day/BT 1st month 2nd month 3rd month/AT

7. Pain abdomen
8. Low backache
11. Constipation
12. Giddiness
14. Diarrhoea
15. Headache
16. Fainting
17. Others associated
symptoms
696
18. Burning sensation in
abdomen
Nausea
Diarrhoea
Skin rashes
19. TC (Cells/Cmm.)
20. DCLLLL P _____% P _____% P _____%
L _____% L _____% L _____%
E _____% E _____% E _____%
M_____% M_____% M_____%
B _____% B _____% B _____%
21. ESR (mm / 1st hour.)
22. Peripheral smear of
blood
23. M.C.H.C. (%)
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7. MENSTRUAL DIARY
MENSTRUAL DIARY FOLLOW UP

Initial (Zero) First month Second month Third month
Date of on set of
menstruation
Menstruation
(i) length of menstrual
cycle in days
(ii) Duration of menstrual
flow in days
(iii) Amount of bleeding
per day (in pads)
Abdominal pain
(i) Day of onset
(ii) Intensity
(iii) Day of relief of pain
Nature of pain
(i) Toda
(ii) Bheda
(iii) Sula
Associated symptoms
(i) Pain in lower limbs
(ii) Nausea / Vomiting
(iii) Constipation
(iv) Giddiness
(v) Breast tenderness
(vi) Diarrhoea
(vii) Headache
(viii) Fainting
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Adverse Reactions
(i) Burning sensation in
abdomen
(ii) Nausea
(iii) Diarrhoea
(iv) Skin rashes
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
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Blank
700
CARDIOVASCULAR SYSTEM
SECTION - XI
Blank
702
RANDOMIZED DOUBLE BLIND CONTROLLED
CLINICAL TRIAL OF AYUSH-HT IN ESSENTIAL
HYPERTENSION
Drug: Study Code:

AND SIDDHA
703
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RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
I. BACKGROUND
Hypertension is the largest risk factor for cardio-vascular disease. This condition may be
comparable with Raktachapa or Vyanabala Vaishamya1 in Ayurveda. This risk is unevenly
distributed because it is also dependent on the number and extent of concomitant risk factors.
Definition: Criteria for the diagnosis of hypertension in various age groups as defined by
7 Joint National Committee Report is as follows:
th
Hypertension is defined as a sustained increase in systolic BP (SBP) of 140 mm Hg or

greater and/or diastolic BP (DBP) of 90 mm Hg or greater. By the usual criteria of average three
B.P. measurements on one occasion 140 systolic and/or 90 mm Hg Diastolic or taking of
hypertensive medication.
Classification of Blood Pressure (Joint National Committee – 7 (JNC-7) guidelines2
Category Blood Pressure mm Hg.

Systolic Diastolic
Normal < 120 and < 80
Prehypertension 120-139 or 80-89
Stage 1 hypertension 140-159 or 90-99
Stage 2 hypertension > 160 or > 100
References
1. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and
Treatment of High Blood Pressure. JAMA 2003; 289(19): 2560-2572.
2. Gordon H. Williams Hypertension vascular disease page 1414-29, Harrison’s Principle of Internal
Medicine, Vol.-I, 15th Edition.
3. Dwiwedi S. Aggarwal MP: Antianginal & Cardioprotective effects of T. Arjuna: An indigenous
drug in coronary Artery disease. J. Ass. Phys. India 1994: 42: 287-289.
4. P.K. Gupta & R.H. Singh: A study on the effect of vaca in cases of essential hypertension and
IHD J.R.A.S. Vol.XVI No.3-4 (1995) PP 93-101.
5. P.V. Sharma Dravya Guna Vigyan 2nd part. Page 31-32.
705
In more than 95% of cases, aetiology of hypertension is unknown. Such patient is
diagnosed as essential hypertension. Secondary hypertension results as a consequence of a
specific disease or abnormality e.g. renal disease, endocrine disorder, drugs, pregnancy.
There are various modern drugs available as anti-hypertensive e.g. Betablockers, ACE
inhibitors, Calcium channel blockers and diuretics but these drugs have side effects and most of
these are not cost effective. Hence, the search for potent safe and cost effective Ayurvedic anti-
hypertensive drugs is exxential.
Ayurvedic drugs like Arjuna, Vacha, Punarnava & Sarpagandha possess anti hypertensive
and cardioprotective effect.
II. OBJECTIVE
To study the effect of Ayurvedic drugs Ayush-HT in essential hypertension.
III. CENTRES
Identify Center of CCRAS
Trial drug : 50 cases
Control : 50 cases
Total Sample Size : 100 at each centre
Level of study : OPD
1. Trial drug: Ayush-HT draggee 750 mg. (Extract of equal parts of Arjuna +
Punarnava + Vacha + Sarpagandha)
Dose: One draggee BD with water after meal.
Duration – Six months (6 months follow up with drug in cases showing control in
Hypertension after 6 months of treatment)
2. Control drug: Hydrochlorothiazide 25 mg. OD with water after the breakfast for
six months. (Control drug will be made similar to trial drug and one placebo
draggee will be prescribed after dinner)
All patients included into the study will be advised to take prescribed diet regimen & light
exercise as per given along with patients information sheet.
Design of the study – Randomized Double Blind Control Clinical trail
706
Duration of the study – six months (6 months follow up with drug in cases showing
control in Hypertension after 6 months of treatment).
Total duration: will be three years to complete the trial.
1. Diagnosed patients of essential hypertension of duration < one year without taking any
anti-hypertensive medication for at least one month
S.B.P. < 160 mm. Hg. and >= 140 mm Hg.
D.B.P. < 100 mm. Hg. and >= 90 mm. Hg.
1. Patient below 35 years and above 60 years of age.
2. Patients with
S.B.P. >= 160 mm. Hg.,<140 mm Hg
D.B.P. >= 100 mm. Hg. and < 90 mm. Hg
3. Patient receiving on anti hypertensive drug
4. Complicated hypertensive cases e.g. Nephropathy and left ventricular hypertrophy, heart
block, congestive heart failure, coronary artery disease and retinopathy
5. Patients suffering with Diabetes
6. Accelerated and malignant hypertension.
7. Patient taking steroids oral contraceptive pills, oestrogen replacement therapy or NSAID
groups of drug.
8. Pregnant women or planning pregnancy with in six months.
9. Patient with severe other illness hepatic/renal failure.
10. Secondary hypertension.
During the course of the trial treatment, if any serious condition develops/symptoms
aggravates due to increase in S.B.P. and D.B.P. which requires urgent treatment , such subjects
may be withdrawn from the trial and managed by the Principal Investigator accordingly.
707
proforma (Forms I & II). Clinical assessment will be done fortnightly during the treatment period and
follow up period (Form III). The laboratory investigations will be recorded before treatment period,
at the end of three months, end of the treatment period and end of the follow up.
IX. ASSESSMENT OF RESULTS
Adequate Blood pressure control i.e. D.B.P. below 90 mm Hg. and S.B.P. below 140
mm. Hg. on three successive readings will be considered as significant outcome of the treatment.
Data on clinical symptoms, physiological parameters and laboratory parameters will be
tabulated & analyzed using appropriate statistical methods.
The monitoring of progress of the trial and data analysis will be undertaken by CCRAS
HQrs., New Delhi.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating Centre’s should give clearance
in duplicate with
A consolidated amount of Rs. ——————— per visit will be paid to subject on
every visit.
708
the patient.
Name: ____________________________
CONSENT BY SUBJECT
this study.
in the clinical trial on “Randomized double blind controlled clinical trial of ayush-HT in
essential hypertension”.

Relationship ___________________________________
709

The available treatment for essential hypertension in modern medical science like
Betablockers, ACE inhibitors, Calcium channel blockers, a blockers and diuretics but these drugs
have side effects and most of these are not cost effective. Hence the search for potent safe and
cost effective Ayurvedic anti-hypertensive drugs.
Your doctor will explain clearly what you have to do. It is important that you should
follow the instructions scrupulously. The study will take approximately one year to complete (six
months treatment period and six months follow up). During this period, you are expected to visit
the hospital 24 times, fortnightly during treatment phase and follow up period.
physical examination, ECG an X-ray and Findus examination. Blood and urine samples will also be
taken. This is to make sure that you are eligible for the study.
If you are found eligible, you would be put on dietary regimen prescribed in the
information sheets besides light exercise. This should be followed during treatment period. During
treatment you will receive either the trial drug or control drug. In cases showing control in
hypertension trial drug will be continued for another six months. After end of the study, patient
will be advised to continue treatment as per advice of the physician.
visit.
Diet regimen: The patients are advised to restrict salt intake (ie less than 5gm per day)
and follow diet as per advice of the treating physician.
Advice for Exercise: The patients are advised to do brisk walking/Jogging or light
exercises for about 30 minutes per day.
The patients will also be advised to avoid smoking.
710
(Before Treatment)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : ..............................................................................................................................
..............................................................................................................................
1. Diagnosed patients of essential hypertension of

duration < one year without taking any anti-hypertensive
medication for 1 month S.B.P. < 160 mm. Hg. > =140 mm Hg.
and D.B.P. < 100 mm. Hg. and >= 90 mm. Hg.
3. Patient below 35 years and above 60 years of age.
4. Patients with
S.B.P. > =160 mm. Hg.,<140 mm Hg and
D.B.P. > =100 mm. Hg. and < 90 mm. Hg
5. Patient receiving conventional anti-hypertensive drug regularly
6. Complicated hypertensive cases e.g. Nephropathy and left

ventricular hypertrophy, heart block, congestive heart failure,
coronary artery disease and retinopathy
711
7. Patients suffering with Diabetes mellitus
8. Accelerated and malignant hypertension.
10. Pregnant women or planning pregnancy with in six months
11. Patients on steroids oral contraceptive pills,

oestrogen replacement therapy or NSAID groups of drug.
12. Patient with severe other illness hepatic/renal failure.
If Sl. No. 1 to 2 is ‘Yes’ and Sl. No. 3 to 13 are ‘No’.
If admitted, Sr. No. of the Subject: ________________________________________________
Date: ____________ Signature of the Investigator _________________
712
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : ..............................................................................................................................
Indicate nature of work : .........................................................................
10. Income per capita per month in Rs. .....................................................................................
Chief complaint with duration (if any) in days Yes (1) No (0) Duration
(in days)
11. Giddiness
12. Irritability
713
13. Fatigue
14. Lack of sleep
15. Headache
16. Any chest pain/palpitation
17. Breathlessness with or without exertion
18. Other symptoms if any specify______________________________________________
History of Present illness:
19. Duration of disease in months_______________________________________________
Treatment received so far Yes (1) No (0)
20. Beta Blockers
21. Calcium Channel Blockers
22. Diuretics
23. Others
24. If yes, specify ___________________________________________________________
Personal History:
25. Diet: Veg Non-veg
26. Sleep: Normal Distrubed
Yes (1) No (0)
27. Presence of Emotional Stress
28. Constipation
29. Occupation: Sedentary Moderate Work
Hard Work
714
Addiction Yes (1) No (0)
30. Smoking
If yes specify: (a) Quantity (Packs) : _____________________
(b) Total Duration in years : ________________
31. Tobacco
If yes specify: (a) Quantity ____________________________
(b) Total Duration in years : _______________
32. Alcohol
If yes specify : (a) Quantity ___________________________
(b) Total Duration in years : _______________
33. Any other (specify) _______________________________________________________
Sannipataj
Family History: Present (1) Absent (0)
32. Hypertension:
Parent:
Siblings:
33. Hypercholesterolemia
Parent :
Siblings:
34. PHYSICAL EXAMINATION:
a) Built Lean Medium Heavy
715
b) Gait Normal Abnormal
c) Body weight ____________ Kg.
d) Body temperature ____________oF
e) Blood pressure: ____________
Systolic ____________ mm/Hg (in sitting posture of right upper limb)
Diastolic ____________ mm/Hg
f) Pulse rate: ____________ /min. (Radial pulse of right upper limb)
g) Respiration rate: ____________ /min.
h) Pallor
i) Jaundice
j) Koilonychia
k) Lymphadenopathy
l) Edema
35. SYSTEMIC EXAMINATION Normal Abnormal
a) CVS with chest
If Abnormal, specify abnormalities____________________________________________
b) CNS
c) Digestive system
d) Uro-genital system
716
e) Respiratory system
f) Abdomen Palpable Not palpable
i) Liver
ii) Spleen
g) Eye examination
If abnormal details of vision disturbance and Fundoscopy _________________________
Date: _____________ Signature of Investigator ___________________
717
CASE RECORD FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
(Fortnightly during treatment period and follow up)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : ..............................................................................................................................
Clinical Parameters
a. Subjective Present (1) Absent (0)
8. Giddiness
9. Irritability
10. Fatigue
11. Lack of sleep
12. Headache
13. Any chest pain/palpitation
14. Breathlessness with or without exertion
15. Other Complaints with if any specify_________________________________________
718
b. Objective
15. Weights ________________________Kg
16. Resting Systolic B.P _________________________mmHg
17. Resting Diastolic B.P _________________________mmHg
Date: _____________ Signature of the Investigator: ________________
719
(Before treatment, end of the 3rd month and after the treatment)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : ..............................................................................................................................
Urine Examination
Routine
8. Sugar: __________________
9. Albumin __________________
10. Deposits __________________
Microscopic
11. Pus cell __________________(hpf)
12. RBC __________________(hpf)
13. Cast __________________(hpf)
720
Stool examination
14. Routine __________________
Microscopic
15. Ova __________________
16. Cyst __________________
17. Occult Blood __________________
Blood
18. Blood Group __________________
19. TC(Cells/Cmm.) __________________
20. DLC: P(%)________ L(%)________ E(%)________M(%)________B(%)________
21. Hb (g/dl) __________________
22. ESR (1st hour.) __________________
23. Blood Sugar- Fasting(mg./dl) __________________
24. Blood Sugar – PP (mg./dl) __________________
25. Blood Urea (mg./dl) __________________
26. S. Creatinine (mg./dl) __________________
27. Uric acid (mg./dl) __________________
LIPID PROFILE
28. Serum total Cholesterol (mg./dl) __________________
29. S. Triglycerides (mg./dl) __________________
30. HDL(mg./dl) __________________
31. LDL(mg./dl) __________________
32. VLDL(mg/dl) __________________
721
LIVER FUNCTION TEST
Serum Bilirubin
33. Total (mg/dl) __________________
34. Direct (mg/dl) __________________
35. SGOT (IU/L) __________________
36. SGPT (IU/L) __________________
37. Alk.Phosphatase (KA units) __________________
38. Total proteins (gm./dl) __________________
39. Albumin (gm./dl) __________________
40. Globulin (gm./dl) __________________
41. A/G Ratio __________________
Serum Electrolytes
42. Sodium (mEq/L) __________________
43. Potasium (mEq/L) __________________
Other investigations
44. ECG __________________
45. X-ray chest (PA View) (only at the beginning of study) _____________________________
46. Fundoscopy (only at the beginning of study) ______________________________________
Date: _____________ Signature of the Investigator: _________________
722
Diet Regimen:
To take 25 kCal/kg per day (Moderate work)
Protein 0.8 gm/kg per day
Fat < 30% of calorie (Saturated fat < 10% Polyunsaturated fat < 8% of total diet)
Cholesterol < 300 mg per day
Dietary fibre 50 gm per day (atleast)
Common salt < 5 gm. per day
Saturated fat e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil, egg and meet These contain highly
saturated fat and cholesterol.
Sun flower oil, Soyabean oil, Olive oil contain unsaturated fat it should be taken 3 small tea
spoonful per day.
Milk: Three cup daily double tone
Whole Cereal: 90 gm daily. Example old Sama rice, wheat, java, with husk.
Vegetable: 250 gm daily. Example Pumpkin, methi, padwal, karaila, and beans.
Non polished Dal: 75 gm. Daily. Example Moong, Masoor, Chana, Arhar.
Fruits: 250 gm. Daily.Example all seasonal like mango, apple, cucumber, pear dhatriphal,
Spices: 05 gm. Per day coriander, Ginger, and Cardamom.
723
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724
PROTOCOL FOR PLACEBO CONTROLLED MULTI-
CENTRIC CLINICAL TRIAL OF AN AYURVEDIC
FORMULATION IN THE MANAGEMENT OF
CHRONIC STABLE ANGINA
Drug: Study Code:

AND SIDDHA
725
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726
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
I. BACKGROUND
Coronary artery disease is an important cause of morbidity and mortality. The incidence
and prevalence of the disease is gradually rising in our country and a substantial portion of adult
population is affected. Some of the Ayurvedic drugs investigated so far have shown encouraging
cardio-protective potential. The classical literature in Ayurveda has described the usefulness of
Arjuna1 and Pushkarmula2 in prevention and treatment of Hridroga (cardiac angina specially
relating to Ischaemic heart diseases). The studies on Arjuna3,4,5 and Pushkarmula,6,7,8,9,10 in many
centers have put forth the efficacy of the drug in the management of ischaemic heart disease and
has been practiced in preventive cardiology. They lower lipids in patients and prevent the increase
in lipids in experimental animals.
Keeping in view the references with the ancient classical literature of Ayurveda and the
leads obtained in the recent studies, the combination of Arjuna and Pushkarmula has been
selected for trial in prevention of cardiac risk factors in cases of Chronic Stable Angina.
References
1. Chakrapani; Chakradutta; Chaukhamba Publication, Varanasi; 3rd Edition, Hridroga (Chapter 21),
verses 8 & 9
2. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Sutra Sthana, Chapter 25,
Verses 40 and Chikitsa sthana, Chapter-26, verses 84-86.
3. Colabawalla, H.M., An Evaluation of Cardio-tonic and other properties of Terminalia arjuna,
Indian Heart.J.3;205-30, 195
4. Singh, N.et.al.: Mechanism of Cardiovascular response of Terminalia arjuna, Ind.J.Pharmacol. II
(I) : 33, 1979
5. Ojha J.K. et.al., I.racemosa, as Hypolipidaemia agent (an experimental and clinical study), Indian
J.Pharm.39 (6);176, 1977
6. Singh, Ramji, et.al. Pushkara guggulu - an Antianginal and Hypolipidaemic Agent in Coronary
Heart Disease (CHD), JRAS, Vol.XII, No.1-2, Pp-1-18 (1990)
7. Singh, N.et.al.; Pharmacological studies on I.racemosa, J.Res. Indian Med.Yoga and Homoeo
11(3):25-32, 1976.
8. Dwivedi S, Agarwal MP. Antianginal and cardioprotective effects of Terminalia arjuna: An
indigenous drug in coronary artery disease.J Ass Phys India 1994; 42:287-289.
9. Bharani A, Ganguli A, Bhargava KD. Salutary effect of Terminalia arjuna in patients with severe
refractory heart failure. Int. Journal Cardiol 1995;49:191-99.
10. Dwivedi S, R. Jouhari.Beneficial effects of Terminalia arjuna in Coronary artery disease: Indian
Heart J.; 49:507-10.
727
II. OBJECTIVE
Effect of Arjuna barks powder and aqueous extracts of Pushkarmula on Chronic Stable
Angina.
III. CENTRES
Run-in Period : One week
Groups : Two (Trial and Control)
Group-I Trial drug
a). Drug : Arjuna twaka (bark of Terminalia arjuna W. & A.) and
Pushkarmula (root of Inula racemosa Hook. f.) in
capsule form (each capsule containing Arjuna bark
powder 500 mg. and aqueous extract of Pushkarmula
derived from 500 mg. of crude drug).
b). Dosage : Three capsule of 500 mg each twice a day.
c). Duration : 90 days
Group II- Control drug (Control drug will be made similar to trial drug)
Design of the study : Randomized Double–blind Placebo controlled study.
Duration of : One week run-in period and three months drug therapy
the study with follow up for three months without drug.
Period of Study : Period of study will be six months for each case. Total
duration will be two and half years to complete the trial at
each Centre.
1. Age more than 35 years of either sex
2. Diagnosed cases of Chronic Stable Angina.
3. TMT positive cases
728
1. Age below 35 years
2. Recent M.I. less than three months
3. Patients with conduction problem
4. Patients with uncontrolled hypertension
5. Unstable Angina
6. Serious concomitant disease of liver and/or kidney
7. Any malignancy
8. Undergoing treatment for any other serious illness
If during the course of the trial treatment, subjects shows the following:
1. any serious toxicity for intolerance,
2. acute myocardial infarction,
3. stable angina progressing to unstable angina and/or,
4. undergoing Coronary re-vascularisation
Subject will be withdrawn from the study. If any other serious condition develops during
the course of study, which requires urgent treatment, such subjects will also be withdrawn from the
trial and managed by the Principal Investigator accordingly.
the Performa (Forms I & II). Clinical assessment will be done before drug administration (0),
after one week of Run-in period, every six weeks during treatment and at the end of follow up
(Form III) (after three months of completion of treatment). The laboratory investigations and TMT
will be recorded before drug administration, after one week of Run-in period and after completion
of treatment (Form-IV). All the patients will be provided a ‘Diary of Events’ for keeping record
of angina attacks and consumption of nitrate tablets.
Data on frequency of angina, consumption of nitro-glycerin tablets, duration of exercise
tolerance on TMT (end point), time taken for 1 mm ST depression, maximum double product,
lipid profile at the end of run-in period and at the end of treatment will be analyzed using
729
improvement in the symptoms.
The progress of the trial will be monitored by Monitoring Unit of CCRAS Head Quarters,
New Delhi.
XII. ETHICAL REVIEW
Each participating center’s Institutional Ethical Committee (IEC) should give a clearance
should be submitted along with the project proposal for approval by IEC. Both should be
maintained in duplicate with one copy given to the patient at the time of entry to the trial.
A consolidated amount of Rs…../- per visit will be paid to subject selected for trial.
personnel involved in the multi-centric trial at CCRAS Hqrs. New Delhi. The investigators and
intimation to this Council about codal formalities.
730
STABLE ANGINA
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending doctor, the purpose of the
in the “Clinical trial of Arjuna and Pushkarmula in the cases of Chronic Stable Angina”.

Relationship ___________________________________
731
STABLE ANGINA

Ayurveda has a very comprehensive approach for the treatment of chronic stable angina.
The present study is aim to evaluate selected Ayurvedic drugs for their efficacy in the treatment of
Ischemic heart disease. You are invited to participate in this study where you will be provided a
combination of Arjuna and Pushkarmula in daily dose of three capsules BD. The previous
observations in clinical and experimental studies have shown promising effect of these drugs in the
treatment of Ischemic heart disease. About 300 cases of Ischemic heart disease from this
and other hospitals around the country will be taking part in this study.
instructions scrupulously. The study will take approximately six months to complete (three months
for treatment and another three months for follow-up study). During this period, you are expected
to visit the hospital five times (0, after one week, six week, 12 week and six months).
physical examination, ECG, X-ray, TMT. Blood and urine samples will also be taken. This is to
make sure that you are eligible for the study. Clinical assessment and lab investigations will be
carried out during subsequent visits.
If you are found eligible, you would be put on trial treatment for three months
and on follow up for three months. The daily dosage will be three capsules twice a day.
At each visit, you will be supplied with sufficient quantities of drugs to last until your
next visit.
732
STABLE ANGINA
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
..............................................................................................................................
2. Diagnosed cases of chronic stable angina
3. TMT positive case
5. Recent M.I. less than three months
6. Patients with conduction problem
7. Uncontrolled hypertension
8. Unstable Angina
733
9. Serious concomitant disease of liver / kidney
10. Malignancy
11. Patients undergoing treatment for any other serious illness
If admitted, subject serial No.: ___________________
734
STABLE ANGINA
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
5. Address : ..............................................................................................................................
Chief complaint with duration (if any) in days Present (1) Absent (0) Duration
8. Chest pain [NYHA Criteria]
If present, indicate:
Location________________________________________________________________
Radiation________________________________________________________________
Type of pain_____________________________________________________________
Frequency of anginal attacks per week ___________________________________________
9. Post-prandial pain
10. Dyspnoea on exertion
11. History of CAD if any in the Past
735
History of present illness
12. Duration of disease (in months)______________________________________________
Treatment given so far Yes (1) No (0)
13. Beta blockers
14. Calcium channel blocker
15. Nitrates
16. Others
If yes, specify____________________________________________________________
17. Family History of CAD
If yes, specify____________________________________________________________
PERSONAL HISTORY
18. Smoking/Tobacco/Pan masala
19. Constipation
20. Sharirik Prakriti: Vataja 1 Pittaja 2 Kaphaja 3
Vata-kaphaja 4 Vatapittaja 5 Pitta-kaphaja 6
Sannipataja 7
General
21. Body weight (Kg.) ________________________
22. Body height (in cm) ________________________
23. Resting Blood pressure (Systolic) mm of Hg ________________________
24. Resting Blood pressure (Diastolic) mm of Hg ________________________
736
Cardiovascular
25. Pulse Rate (per minute) ____________________________________________________
26. Pulse Rhythm Regular 0 Irregular 1
27. Apex beat Normal 0 Abnormal 1
28. Heart sound Normal 0 Abnormal 1
29. Jugular venous pulse. Normal 0 Abnormal 1
30. Congestive Cardiac Failure
31. Oedema
GASTRO INTESTINAL TRACT
32. Hepatomegaly
33. Splenomegaly
RESPIRATORY
34. Crepitation
35. Rhonchi/Wheezing
CENTRAL NERVOUS SYSTEM
36. Normal Yes 1 No 0
737
STABLE ANGINA
(0, 1st, 7th, 13th and 25th week)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
Clinical Parameters
A. Subjective Present (1) Absent (0)
8. Chest pain
[NYHA Criteria for Class II/III]
If present, indicate:
Location _____________
Radiation _____________
Type of pain _____________
Frequency of anginal attacks per week
12. Post-prandial pain
738
13. Dyspnoea on exertion
B. Objective
11. Body weight (in kg): ______________________________________________________
12. Resting Blood pressure (Systolic) (mm of Hg): __________________________________
13. Resting Blood pressure (Diastolic) (mm of Hg): _________________________________
739
PLACEBO CONTROLLED MULTI- CENTRIC CLINICAL TRIAL OF AN
STABLE ANGINA
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
7. Address : Permanent postal address with phone number and email if any.
..............................................................................................................................
..............................................................................................................................
ADVERSE EVENTS
1 2 3 4
Adverse
Experience
740
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3

Serious*
Yes-1
No-2

741
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
742
STABLE ANGINA
('O' day, after one week of Run in period and after end of the treatment)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
7. Address : Permanent postal address with phone number and email if any.
..............................................................................................................................
..............................................................................................................................
9. Stage of Assessment (in weeks)
Urine Examination (Microscopic)
10. Sugar: ______________
11. Albumin: ______________
12. Deposits: ______________
Blood
13. Hb(g/dl): ______________
14. Blood Sugar-Fasting (%) ______________
15. Blood Sugar – PP(mg./dl)______________
16. S. Cholesterol (mg./dl) ______________
743
17. HDL (mg./dl) ______________
18. LDL (mg./dl) ______________
19. Triglycerides (mg./dl) ______________
20. B. Urea (mg./dl) ______________
21. S. Creatinine (mg./dl) ______________
22. Uric acid (mg./dl) ______________
23. SGOT ______________
24. SGPT ______________
Radiological Investigations
25. X-ray Chest: [ 0 Month only ] ___________________________________
___________________________________
Special Tests
26. ECG (report all details) ___________________________________
___________________________________
TMT (Bruce Protocol)
27. Duration of exercise (in minutes & seconds) (min.) (sec.)
{Mets-…….]
28. Time to 1mm ST depression( in seconds)
29. Maximum double product
30. Maximum ST segment depression (in mm)
31. Leads showing ST depression:
L1 L2 L3 aVR aVL aVF
V1 V2 V3 V4 V5 V6
If in other special leads, specify________________________________________
Date: _____________ Signature of the Investigator ______________________
744
URINARY SYSTEM
SECTION - XII
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746
MULTICENTRIC DOUBLE BLIND PLACEBO
CONTROLLED CLINICAL TRIAL OF AN AYURVEDIC
FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
Drug: Study Code:

AND SIDDHA
747
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748
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
I. BACKGROUND
Urinary calculi consist of aggregation of crystals and small amounts of proteins and
glycoproteins but their genesis is poorly understood. Different types of stone occur in different
parts of the world with different chemical composition. Dietary factors probably play a part in
determining the varying patterns. In developing countries, bladder stones are common particularly
in children. In industrial countries the incidence of childhood bladder stone is low and renal stones
in adults are more common. In this condition there may be urinary calculi anywhere in the urinary
tract.
Detailed descriptions concerning the etiology, clinical features and line of management of
this condition is available in classical literature of Ayurveda. The common features of presentation
are pain and obstruction to flow of urine with/without haematuria. The management of urinary
calculi is revolutionized during the last 2-3 decades. The surgical treatment, endourology and
ESWL can effectively treat/manage the existing calculi but the problem of residual fragments and
recurrence of calculi persists.
The medical treatment is effective in the management of small calculi, residual fragments
and prevention of urinary calculi. Keeping this in view various Ayurvedic drugs like Shveta Parpati,
Gokshuru, Varuna, Pashana Bheda, Kulattha and Palash Kshara prescribed in ancient Ayurvedic
texts have been studied in the management of this condition.
References
1. Sannd, B.N., Kumar, Anil and Kumar, Naresh: To evaluate the effect of Ayurvedic Drugs
Shveta Parpati with Pasana Bheda and Gokshuru in the management of Mutrashmari
(urolithiasis); JRAS, Vol.XIV, No. 3-4 , Pp.98-114, 1998.
2. Kumar, Anil and Kumar, Naresh: To evaluate the effect of Ayurvedic drugs – a herbomineral
comibiation of Shveta Parpati with Kulatha Kwatha in the management of Mutrashmari
(urolithiasis); JRAS, Vol. XVI, No.1-2, Pp.35-42, 1995.
3. Kumar, Anil and Kumar, Naresh: To evaluate the effect of Palasha Kshara in the management
of Mutrashmari (Urolithiasis); JRAS, Vol.XVI, No.1-2, Pp.43-50, 1995.
4. Singh, L.M., Shukla, J.P. and Deshpande, P.J.: Monograph on “Management of Mutrashmari
by three Ayurvedic Drugs Varuna, Kulatha and Gokshuru”, C.C.R.A.S., New Delhi, 1987.
749
Shveta Parpati with decoction of Gokshuru and ,Pashana Bhed1; Shveta Parpati with
decoction of Kulattha2; Palash Kshara3; and Varuna, Kulattha and Guggulu4 have been found quite
effective in management this condition. The present multricentric clinical trial is proposed with a
view to re-establish the efficacy of this formulation for the management of urolithiasis.
II. OBJECTIVE
To assess the efficacy of Shveta Parpati and Palash Kshara with the aqueous extract of
Kulattha, Pashana Bheda, Gokshuru in the cases of Mutrashmari (Urolithiasis).
III. CENTRES
CCRAS centers in collaboration with other centers.
Sample Size : 120 Subjects (60 subjects in each group)
Groups : Two – trial and control
Drug/Dosage/Duration : Trial drug in one group
(i) Drug : Shveta Parpati 1and Palash Kshara 2 with the
aqueous extract of Kulattha3, Pashan Bheda4 and
Gokshuru5, all in equal quantity.
(ii) Dosage : Two capsules of 500 mg each TDS
(iii) Duration : 90 days and placebo in another group.
Design of the study : Randomised Double – blind Placebo controlled
study.
Duration of the study : Three months drug therapy with follow up for nine
months without drug
Total period of study : Total one year, registration of the patients should
be done only in first fifteen months of the start of
the study.
Period of Study : Twelve months for each case. Total duration will be
two and half years to complete the trial at each
Centre.
Follow – Up : Three follow-ups will be carried out after 3rd, 6th
and 9th after completion of treatment.
750
1. Age: between 15 to 60 years
2. Sex: either sex
3. Radiological evidence of stone (upto 10 mm) in kidney, ureter and urinary bladder
2 Stone size more than 10 mm
2. Impacted stone
3. Gross hydronephrosis
4. Pyelonephritis
6. Malignancy
7. Impaired renal function
8. Poorly functioning kidney
9. Patients with obstruction in urinary passage.
10. Patients with known metabolic abnormality for calculus formation
11. Any other complication of calculus.
During the course of the trial treatment, if any serious condition develops which requires
urgent treatment such subjects may be withdrawn from the trial and managed by the Principal
the proforma (Forms I & II). Clinical assessment will be done before drug administration (0), at
the end of Ist, IInd, IIIrd months during treatment and at the end of 6th, 9th and 12th months
during follow up (Form III). The laboratory and radiological investigations will be recorded before
drug administration (0 month), at the end of treatment (3 months) and at the one year (12
months) as per proforma (Form IV)
751
Radiological evidence of disappearance or reduction in the size of the stone, Clinical
parameters and laboratory parameters will be analysed using appropriate statistical methods.
The progress of the trial will be monitored by Monitoring Unit of CCRAS Head quarters,
New Delhi.
XI. ETHICAL REVIEW
Each participating centre’s Institutional Ethical Committee (IEC) should give clearance
752
(UROLITHIASIS)
PATIENT CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending doctor, the purpose of the
in the “Clinical trial of Shveta Parpati, Palash Kshara, Kulattha, Pashana Bheda and Goksuru in
the cases of Mutrashmari (urolithiasis)”.

Relationship ___________________________________
753
(UROLITHIASIS)

Ayurveda has a very comprehensive approach for the management/treatment of
Mutrashmari (Urolithiasis). The present study is aim to evaluate selected Ayurvedic drug for its
efficacy in the treatment of Urolithiasis. You are invited to participate in this study where you will
be provided a combination of Shveta parpati, Palash Kshara, Kulattha, Pashana Bheda and
Gokshuru. in daily dose of two capsules TDS. The previous observations in clinical and
experimental studies have shown promising effect of these drugs in the treatment of Urolithiasis.
About 360 cases of urolithiasis from this and other hospitals around the country will be taking part
in this study.
instructions scrupulously. The study will take approximately 12 months to complete (3 months for
treatment and another 9 months for follow-up study). During this period, you are expected to visit
the hospital seven times (0, 1st, 2nd, 3rd, 6th, 9th and 12th months). The interval between the first,
second, third and fourth visits will be around four weeks. Then there will be three more visits after
every three months of last visit of third month.
physical examination, ECG, X-ray and IVP. Blood and urine samples will also be taken. This is to
If you are found eligible, you would be put on trial treatment for 3 months and on
follow up for 6 months. The daily dosage will be two capsules thrice a day. At each visit,
754
(UROLITHIASIS)
BEFORE TREATMENT
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
6. Address : ..............................................................................................................................
..............................................................................................................................
2. Either Sex
3. Radiological evidence of stone upto 10 mm in size
5. Stone size more than 10 mm
6. Gross hydronephrosis
7. Pyelonephritis
755
9. Malignancy
10. Impacted stone
11. Impaired Renal Function
12. Poorly functioning kidney
13. Patients with obstruction in urinary passage.
14. Patients with known abnormality of calculus formation
15. Any other complication of calculus.
If admitted, subject serial No.: ___________________
756
(UROLITHIASIS)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
Illiterate (1) 1 Read and write (2) 2 Primary (3) 3
Middle school (4) 4 High school (5) 5 College (6) 6
Others (specify) (7) 7 INA (8) 8
10. Occupation
Indicate nature of work………………………….................................................
Chief complaints with duration in days Absent (0) Present (1) Duration
9. Intermittent dull or colickly flank pain
10. Haematuria
757
11. Crystalluria
12. Turbid urination
13. Intermittent flow of urine
14. Increased frequency
15. Burning micturation
16. Others
If yes specify____________________________________________________________
18. Duration of disease (in months)______________________________________________
No (0) Yes (1)
19. Past illness of urinary stone
If yes, give details_________________________________________________________
20. History of any other Urological /Nephrological illness
21. Family history of Urolithiasis
PERSONAL HISTORY
22. Diet Veg.(1) Non-veg (2)
23. Fluid intake Less than one ltr.(1) 1-2 ltr. (2)
2-3 ltr. (3) more than 3 ltr. (4)
24. Prakriti: Vataja 1 Pittaja 2 Kaphaja 3
Vata-kaphaja 4 Vatapittaja 5 Pitta-Kaphaja 6
Sannipataja 7
758
25. Addiction No (0) Yes (1)
If yes, Specify____________________________________________________________
27. Body weight (Kg.) ___________________
28. Body height(in cm) ___________________
29. Blood pressure (Systolic) ___________________
30. Blood pressure (Diastolic)___________________
31. Anaemia Absent (0) Present (1)
32. C.V.S. (with Chest)
33. C.N.S.
35. Respiratory System
Uro-Genital system
36. External gelitalia
37. Prostate
759
Palpable (1) Non-palpable (2)
38. Kidney
39. Bladder
40. Any other, positive finding No (0) Yes (1)
760
(UROLITHIASIS)
(0, 1, 2, 3, 6, 9 & 12th months)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
Clinical Symptoms Present (1) Absent (0)
9. Intermittent dull or colickly flank pain
10. Haemturia
11. Crystalluria
12. Turbid urination
13. Intermittent flow of urine
14. Increased frequency
15. Burning micturition
16. Other if any
If yes, specify____________________________________________________________
Date: ___________ Signature of the Investigator: ________________
761
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PLACEBO
CONTROLLED CLINICAL TRIAL OF AN AYURVEDIC FORMULATION ON
MUTRASHMARI (UROLITHIASIS)
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
ADVERSE EVENTS
1 2 3 4
Adverse
Experience
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Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3

Serious*
Yes-1
No-2

763
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Possible: Follows a reasonable temporal sequence from administration of the drug; follows a
Probable: Follows a reasonable temporal sequence from administration of the drug; follows a
764
(UROLITHIASIS)
(0, 1st, 3rd and 12th MONTH)
1. Centre : ...................................
3. Subject Name : ....................................................................................................................
Urine Examination
9. Routine: _______________________________
10. pH _______________________________
11. Microscopic _______________________________
12. RBC _______________________________
13. WBC _______________________________
14. CRYSTALCASTS_______________________________
15. Urine culture _______________________________
16. Culture sensitivity_______________________________
765
Hours Urine Analysis
17. Calcium _______________________________
18. Phosphate _______________________________
19. Uric acid _______________________________
20. Total protein _______________________________
21. Oxalate (Optional) _______________________________
22. Citrate (Optional) _______________________________
Blood
23. Hb (g/dl): _______________________________
24. ESR (1st hour.)(mm) _______________________________
25. Parathormone assay(optional) _______________________________
26. Blood Sugar – PP(mg./dl) _______________________________
27. S. Cholesterol(mg./dl): _______________________________
28. B. Urea (mg./dl): _______________________________
29. S. Creatinine (mg./dl) _______________________________
30. Uric acid (mg./dl) _______________________________
31. Total proteins (gm./dl) _______________________________
32. Albumin(gm./dl) _______________________________
33. Globulin(gm./dl) _______________________________
34. A/G Ratio _______________________________
35. Serum calcium (mg/dl) _______________________________
36. Serum phosphate (mg/dl) _______________________________
37. ECG: _______________________________
766
Radiological Investigations
38. X-ray Chest: [ 0 Month only ] _______________________________
Plain X-ray (KUB)* [0, 3rd, 6th, 9th 12th Month] ____________________
39. Radio-opaque shadow
40. Site _______________________________
41. Size (in mm) _______________________________
42. Shape _______________________________
43. Opacity _______________________________
Intravenous pyelography (0, 3 Months)
Kidney
44. Size
45. PCS Normal 1 Abnormal 2
If, abnormal specify _______________________________________________________
46. Hydronephrosis Normal 1 Abnormal 2
If, present indicate grade (I,II,III)_____________________________________________
47. Location of Calculus
48. Ureter Normal 1 Dilated 2
49. Bladder Normal 1 Abnormal 2
Ultra Sound (Optional)
Kidney
50. Size
51. Hyderonephrosis
52. Thickness of parenchyma
767
53. Ureter Normal 1 Dilated 2
54. Bladder Normal 1 Abnormal 2
55. Prostate Size (Grade I,II,III,IV)
56. PVR Insignificant 0 Significant 1
If in-significant, specify_____________________________________________________
Stone Analysis as and when passed
57. Chemical Analysis
58. X-Ray diffraction
Date: _____________ Signature of the Investigator_______________________
768
VECTOR BORNE DISEASES
SECTION - XIII
Blank
770
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF
CERTAIN HERBAL / HERBOMINERAL DRUGS IN
THE MANAGEMENT OF KALA-AZAR
Drug: Study Code:

AND SIDDHA
771
Blank
772
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HERBAL /
HERBOMINERAL DRUGS IN THE MANAGEMENT OF KALA-AZAR
I. BACKGROUND
The disease Kala-azar also known as Visceral Leishmaniasis is a highly fatal disease
caused by Leishmania donovani. The origin or entity of the disease may not be historic but
according to classical literature may be correlate with same of the symptoms found resembles
with ‘SATATAK JWAR’ under the group of Vishamajwara. Though the Visceral Leishmaniasis is
caused due to the bite of sandflies transporting the organism / parasite Leishmania donovani which
is not described in Ayurveda but the causative factor of ‘SATATAK JWARA’ may be correlated
with ‘Bhutabhisanga’. Then probably Leishmania donovani might have been discovered by present
era. However the sign & symptoms like spleenomegaly (Pleihavriddhi). Fever (Mandajwara).
Vishamarambha is the cardinal symptoms in ‘SATATAK JWARA’ upon which Kala-a-zar may be
taken as in prevalence with modern synonyms.
In India, man is the reservoir of infections, and parasite are readily obtainable from
peripheral blood by the sand fly (rodents and dogs are the main reservoir hosts in African venereal
leishmaniasis). Visceral Leishmaniasis may occur in epidemics and recording of epidemic outbreaks
in India goes to year 1870.
Keeping in the view and considering these above aspect, the persistent morbidity, high
mortality and high toxicity of present available modern drugs especially Pentamedin,
Amphotericin‘B’ and Sodium stibogluconate etc. and some herbo-mineral compound has been
shorted out for the management of Kala-azar and aspecting the probable results due to containing
Antimony sulphide (modern drug of choice) i.e. Srotonjana.1
Apart from this some Hepato-protective and Spleeno-protective, Heamatinic, febrifuge
herbal drugs i.e. Guduchi, Sharpunkha, Kalmegha, Rohitaka, Sakhotaka, Saptaparna, Sudarshana
and Punarnava etc. are possible suitable Ayurvedic drugs in this ailment and this project has been
selected for clinical trial.
References :
1. Pandit.Kasinath Sashtri and Dr. Gorakhanath Chaturvedi (1984) Charaka Samhita, (text with
Hindi commentary) XIIth Edition (1984), Published by Chaukabha Vidhya Bhavan, Varanasi,
India
2. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998,
Published by McGraw-Hill CompaniesInc.
3. Ambika Dutta Sashtri(1989), Susruta Samhita (text with Hindi commentary), VIIth Edition
Chaukhamba Sanskrit Series Office, Varanasi
773
II. OBJECTIVE
To evaluate the efficacy of some Herbal / Herbomineral drugs in the management of Kala-
Azar.
III. CENTRE
CCRAS centers in collaboration with other centers.
Sample size- 300
Groups –
Group Total Cases Drug & Dose
Group – I (Treated group) 150
Group – II (Treated group) 100
Group – III (Control group) 50 Amphotericin’B’
(Treated with modern medicines)
Allocation of the cases in each group will be made on randomize by a statistician.
Treatment: Some Herbal / Herbomineral drugs
Design of study: Open trial with standard control group.
Duration of study: 2 years ( 1 year for treatment and 1 year for follow up)
Total period of study: 2 years

1. Age – 10 to 60 years
2. Sex both male & female
3. Positive cases of Kala-azar (Leishmania donovani in spleen / bone marrow
aspirate )
4. Clinical diagnosis of active VL (visceral leishmaniasis) with consistent signs &
symptoms (e.g. Fever & spleenomegaly)
5. Haemoglobin 5 gm / dl
6. WBC > 1500/mm3
774
1. Age below 10 yrs & above 60 yrs.
2. Pulmonary tuberculosis
3. Severe Jaundice / Hepatitis
4. Pregnancy / Lactating mother
5. HIV positive serology / Malignancy
6. Any other serious systemic disease.
7. Hepatic-spleenomegaly due to other diseases.
8. History of Renal disease / Cardiac disease.
VII. CRITERIA FOR WITHDRAWL FROM STUDY

events which requires urgent treatment or if patient himself want to withdrawn from the study, such
subject may be withdrawn from the trial and managed by the principal Investigators accordingly
VIII. ROUTINE EXAMINATION & ASSESSMENT

A detailed clinical history and physical examination of each patient will be recorded as per
proforma (From I & IA). The clinical pathological, Biochemical and other lab investigation will be
done before treatment, during treatment period and at the end of the treatment will be carried out
as per recorded in the proforma. The assessment of the results will be done on the basis of
disappearance of L.D. bodies and improvement in clinical features.

X. CRITERIA OF ASSESSMENT
1. Disappearance of parasite (L.D. bodies)
2. Absence of Pyrexia & other clinical symptoms.
3. Negative L.D. bodies in bone marrow / spleen aspirate found at the end of
treatment (clinical improvement), smear stained for demonstration of Leishmania
donoveni bodies (L.D. Bodies).
775
4. Culture Aspirates (for L.D. Bodies) of the following
5. Aldehyde Test
6. R.K. 39 Kit test
7. Urea stibamin test
XI. TRIAL MONITORING AND DATA ANALYSIS:-

The monitoring of progress of the trial and data analysis will be undertaken by CCRAS,
H.Q. New Delhi.
XII. ETHICAL REVIEW

Each Institutional Ethical Committee (IEC) of participating centers should give clearance
certificate before the project initiated. Patient’s information sheet and informed consent form should
be submitted along with project proposal for approval by IEC. Both should be maintained in
duplicate with one copy given to the patient at the time of entry of trial. The study will be
conducted in accordance with Good Clinical Practice.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS:

A consolidated amount of Rs…../- per visit will be paid to subject.


776
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HERBAL /
CERIFICATE BY INVESTIGATOR
the patient.
Date: …………………… Signature …………………..
Name ………………………
CONSENT BY SUBJECT
I have been informed to my satisfactory, by the attending physician, the purpose of the
in the clinical trial on “Assessment of the Therapeutic efficacy of certain Herbal / Herbomineral
drugs in the management of Kala-azar.”
Date: ………… Name of the Subject: ………………..................

Signature or Thumb impression…………….........
Date: ………… Name of witness: ……………………….............

Signature or Thumb impression: ………...............
Relationship ……………………………..............
To be translated into regional language
777
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HARBAL /

The available treatment for Kala-azar in modern medical science like amphotericin’B’,
sodium stibogluconate etc. Modern medicine have made tremendous success in providing the relief
but is drug resistence & adverse effects are found in treatment. In Ayurveda, certain Herbal /
Herbomineral drugs that have been in practice as well as have shown anti-kala-azar effect have
been taken up for the study.

instructions scrupulously. The study will take approximately 7 days to complete. During this
period, you are expected to visit the hospital for clinical and physiological assessment.
physical examination, & R.K.-39 test, spleen-bone marrow aspirate for L.D. body and other
essential lab-investigations of blood and urine samples will also be taken. This is to make sure that
If you are eligible, you would be put on trial treatment for Kala-azar. During visit, you
will be supplied with sufficient quantities of drugs to last until your next visit. If any adverse
reactions like skin allergy, nausea, vomiting and palpitation / tremor etc., noticed during the
treatment period, this should be noticed to the Principal Investigator.
Advice: (To be given along with Patients Information Sheet)

1. To avoid trigger factors like allergens if known.
2. To avoid respiratory irritants like tobacco, smoke and chemicals.
3. To have warm and fresh food and drinks.
Sympathetic discussion of the problem with the patient and assurance.
778
CLINICAL EVALUATION OF SINGLE / COMPOUND HERBO /
HERBOMINERAL COMPOUND DRUGS IN THE MANAGEMENT OF
KALA-AZAR
BEFORE TREATMENT
(Enter a √ in the appropriate box)
1. Name of the Subject: …………………………………........……………………………
2. Address …………………………………………………….......……………………….
3. Centre…………………………………
7. Group: Treatment Treatment Control
CRITERIA OF SELECTION Yes(1) No(0)
1. Age 10 to 60 yrs.
2. Positive Symptoms of Kala-azar (L.D. bodies)
3. Fever
4. Enlarged spleen
CRITERIA OF EXCLUSION Yes No
5. Age below 10 yrs and above 60 yrs.
. Pulmonary Tuberculosis
7. Severe Jaundice
8. Pregnancy
9. Malignancy
Any other severe systemic disease
Date: …………………… Signature of the Investigator: …………………..
779
CLINICAL EVALUATION OF SINGLE /COMPOUND /HERBO /
HERBOMINERAL COMPOUND DRUGS IN THE MANAGEMENT OF
KALA-AZAR

1. Name of the Subject: ………………………………………….......……………………
2. Address ……………………………………………………………......……………….
4. Centre…………………………
8. Date of admission: Date of discharge:
10. Educational status: Illiterate (1) 1 Read and Write (2) 2

Primary School (3) 3 Middle School (4) 4
High School (5) 5 College (6) 6
Other (specify) (7) 7 I.N.A. (8) 8
Indicate nature of work: ..................................................................................................
12. Total income of the family in Rupees: ______________________
780
14. Income per capita per month in rupees: ____________________
Christian 4 Parsi 5
16. Marital status Married 1 Unmarried 2 Widow 3
Divorced 4 Widower 5
17. Result: Good Response 1 Fair Response 2
Poor Response 3 No Response 4
Drop out 5 LAMA 6
Death 7
CHIEF COMPLAINTS WITH DURATION (in days)

Fever Present Absent Duration
18. With / without chill
19. Low grade (Patient remaining ambulant intermittent
20. With sweating
21. Double rise in 24 hours
22. Diarrhoea
23. Pain in abdomen
24. General Weakness
25. Bleeding (site)
26. Onset of disease: Acute (1) Insidious (2)
27. Duration of disease (in days):
28. Treatment given so far: Ayurvedic medicine Modern medicine

Unani Homeopathy
Mixed
781
Spell out the medicine given and results obtained: _______________________________
PREVIOUS MODERN TREATMENT (if any)

Drug Total quantity Duration Response
29. Pentavalent Antimony _____________________
30. Pentamidin / Lomidin _____________________
31. Allopurinol _____________________
32. Anti-tuberculosis _____________________
33. Other _____________________
34. Factors aggravate the disease / chief complaint:
Drug Diet Cold climate Tropical climate
Damp climate Sea sore
Positive factors may be spell out ……………...........................………………………….

35. Factors relieve main complaints:-
Drug Diet Cold climate Tropical climate
Damp climate Sea sore
Positive factors may be spell out ……………...........................………………………
36. Past illness, having relation with present illness: Yes No
Family History Yes (1) No (0)
37. Hypertension
38. Diabetes Mellitus
40. Mental disease
41. Cancer
42. Cardio Vascular disease
782
43. Tuberculosis
44. Others (specify) ………………………………….......................………………………..
Personal History
45. Diet: Veg Non-veg Lacto-ova veg
47. Emotional stress: Yes No
48. Bowel habit Regular Constipation
Hard stool Loose stool
49. Sharira Prakriti Vata Pitta Kapha
Sama
50. Manasa prakriti Satva Rajas Tamas
Satva- rajas Satva-tamas Rajas- tamas
Sama
51. Addiction: Yes No
If yes specify …………………....................……………………………………………
52. Built: Lean Medium Heavy
54. Body weight (Kg): ___________________________

55. Blood pressure (Systolic) ___________________________
56. Blood pressure (Diastolic) ___________________________
57. Body temperature ___________________________
58. Pulse rate per min. ___________________________
783
59. Respiration per min. ___________________________
Yes No
60. Pallor
61. Jaundice
62. Emaciation
Present Absent
63. Lymphadenopathy
If present indicate group …………………..................................……………………….
64. Increased pigmentation of the skin

If yes specify: On face ________________ Other part ____________
Normal Abnormal
65. Hair distribution
If abnormal specify …………………................................……………………………..
66. Gums
If abnormal specify ………….................................………….............…………….........
Abdomen
67. Shape: Normal Abnormal
68. Distention : Present Absent
If present indicate ……................................…………………………………………..
69. Distended veins: Present Absent
70. Umbilicus: Normal Abnormal
If Abnormal specify ……….................................................……………………………….
71. Tenderness : Yes No
If yes specify ………………………...................................…………………………….
72. Rigidity: Present Absent
784
If present then specify ……………….......................................................……………
73. Spleen: Mild Moderate Massive
enlargement
74. Spleen-consistency Soft Hard Firm
75. Liver Enlarged: Yes No

If yes then indicate the measurement in cm
76. Kidney: Palpable Not Palpable
77. Any other abdomen Masses: Palpable Not Palpable
78. Ascities: Present Absent
Normal Abnormal
79. Hernial Orifices:

If abnormal, specify abnormalities ……………………………………….......………….
80. C.V.S. with chest
If abnormal, specify abnormalities …………………........……………………………….
81. C.N.S.
If abnormal, specify abnormalities ………………………........………………………….

If abnormal, specify abnormalities ……………………………........…………………….
Samprapti (Pathogenesis) of the disease according to Ayurvedic concept
Vata Pitta Kapha

84. Anubandha dosha
85. Avraka dosha

86. Ksheena dosha
87. Ksheena dhatu: Rasa Rakta Mamas Meda
Asthi Majja Shukra Ojas
785
88. Dushya Involved: Rasa Rakta Mamas Meda
Asthi Majja Shukra
89. Stages of disease (Roga Kriya Kala): Sthana – Sanshraya Sanchaya

Prakopa Prasar
Vyakti Bheda
Srotas Examination Yes No

90. Annavaha Srotas
Anannabhilasha (Loss of appetite)
Aruchi (Anorexia)
Avipaka (Indigestion)
Chhardi (Vomiting)
91. Prana Vaha Srotas
Alpa Alpa Swasa (Dyspnoea)
Atisarana Swasa (Increased Respiration rate)
Abhikshna Swasa (Chyne Stroke Breathing)
Kupita Swasa (Vitiated, breathing)
Shashula Swasa (Dyspnoea with pain)
92. Udak Vaha Srotas

Jihva Shosha (Dryness of tongue)
Dusth Shosha (Dryness of lip)
Talu Shosha (Dryness of palate)
Kanth Shosha (Dryness of buccal cavity)
Kloma Shosha (Excessive thirst)
Trishna (Feeling of thirsty)
786
Yes No
93. Pureeshavaha Srotas
Alpa alpa purisha (Not clear, repeated, scanty defecation)
Sashoola Purisha (Painful defection)
Atidrava pureesha (Diarrhea)
Atigrathita pureesha (Scybala)
94. Mutravaha Srotas
Bahumatrata (Polyurea)
Atibandhata (Scanty urination)
Prakupita Mutrata (Difficulty in urination)
Alpa Alpa Mutrata (Scanty urination)
Abhikshna Mutrata (Constant/repeated -urination)
Bahul Mutrata (Urine with prostatic secretia)
Sashoola Mutrata (Dysuria)
95. Svedavaha Srotas

Aswedana (Dryness of skin)
Atiswedana (Profuse sweating)
Parushya (Roughness of skin)
Lomaharsha (Erection of hair follicle)
Angaparidaha (Burning sensation in the body)
Yes No
96. Rasavaha Srotas

Mukha Vairasya (Bad test in mouth)
787
Arasajnata (Testelessness)
Hrillasa (Nausea)
Gaurava (Feeling heaviness)
Tandra (Drowsiness)
Angamarda (Body cramps)
Jvara (Fever)
Pandu (Anaemia)
Avasada (Lassitude)
Klaivya (Sexual inadequacy)
Karshya (Emaciation)
Agnimandya (Diminished appetite)
97. Rakta Vaha Srotas
Pidika (Boils)
Raktapitta (Bleeding from any of the orifice)
Mukhapaka (Stomatitis)
Vidradhi (Absess)
Charma Roga (Skin disease)
Kamala (Jaundice)
Yes No
98. Mamsa Vaha Srotas
Arbuda (Tumor)
Alajee (conjunctivitis)
Gandamala (Cirvical Lymphadinitis)
Upajivihika (Epiglotitis)
Adhimansa (Protuberance of flesh/Cancer/Cyst)
788
99. Medovaha Srotas
Maladhikya (Excess of excreta)
Hastapadadaha (Burning sensation in the sole & palm)
Hastapadasunata (Numbness of the limbs)
Tandra (Drowsiness)
Dehachikkanata (Greasiness of the skin)
Alasya (lethargy)
100. Asthivaha Srotas
Adhyasthi (Hypertrophy of bone)
Adhidanta (Redudant tooth)
Dantashoola (Toothache)
Asthishoola (Tenderness of bone)
Kesha, Loma, Nakha, Smashru Vikar
(Any defects of hair, hair follicle, nail and mustaches)
101. Majja Vaha Srotas
Parvashoola (Pain in the Inter-phalangeal joint)
Bhrama (Vertigo/Giddiness)
Murchha (Syncope)
Mithyagyana (Illusion)
102. Sukravaha Srotas
Klaivya (Sterlity / Impotency)
Aharshana (Loss of erection)
Garbhapata (Abortion)
789
Santana Vikriti (Congenital deformity of the children)
103. Artavavaha Srotas
Anartava (Amenorrhoea)
Vandhyatva (Sterility)
104. Provisional Diagnosis :-
105. Final Diagnosis :-
106. Medical Management :-
107. Principal Drug Therapy :-

Dose
Vehicle
Diet
108. Summary of finding :-
Date: ……………. Signature of the Investigator: ……………………………..
790
COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE / COMPOUND / HERBOMINERAL
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-A-ZAR
CASE REPORT FORM III -CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(2, 4, 6 & 8 weeks)
(For periodic observation & assessment Parameter to be taken for assessment of

response of therapy initially at the time of Admission / Enrollment after starting therapy)
1. Name of the Subject: ………………………………………………….........……………
2. Address ……………………………………………………………………...........…….
4. Centre…………………………
8. Date of admission: Date of discharged:

1. Clinical Parameter
Before Treatment After Treatment
2 weeks 4 weeks 6 weeks 8 weeks
a) Subjective symptoms
1. Fever
2. Loose motion
3. Pain abdomen
4. Weakness
5. Bleeding
791
b) Objective signs
1. Temperature
2. Pallor
3. Anemia
4. Emaciation (Body wt.)
5. Pulse rate
6. Lymphadenopathy
7. Increased pigmentation of the skin
8. Enlargement of spleen
9. Enlargement of liver
10. Measurement of girth of abdomen.
Date: …………………….. Signature of the Investigator: ……………………….
792
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-A-ZAR
(2, 4, 6 & 8 weeks)
1. Name of the Subject: ………………………………………….......................……....…
2. Address ……………………………………………………………..............…………..
4. Centre…………………………
8. Date of admission: Date of discharge :
ADVERSE EVENTS
1 2 3 4
Adverse
Experience
793
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3

Serious*
Yes-1
No-2

794
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
795
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-AZAR
1. Name of the Subject: …………………………………………........……………………
2. Address …………………………………………………………….......……………….
4. Centre…………………………
8. Date of admission: Date of discharge :
Investigation at the sample taken At the After 15 After 45 After 60

time of days days days
admission
1 2 3 4
Urine
10. Sugar: ……………………....……
11. Albumin: …………………………
12. Pus cell: …………………………
13. Cast: ……………………….........
14. RBC: ………………………....…
15. Bile salt: …………………….…..
16. Bile pigment: …………………....
796
Stool
17. Ova: ……………………..............….......…
18. Cyst: ……………….................……........…
19. Occult blood: ………………………….......
20. Stercobiline: ………………………...….......
21. Sputum A.F.B: ………………………….....
HAEMATOLOGICAL INVESTIGATION
Blood
22. Hb.% : …………………….........................
23. T.L.C.(In thousands) : ……………………..
24. D.L.C.: P (%): ______ L (%) ______ B (%) _______ M (%) _______ E (%) _______
25. E.S.R.: ………………….............................
26. P.C.V.: ………………………......................
27. M.C.V.: ………………………....................
28. Platelate count: …………………….........…
29. Reticulo Cyte: …………..……....................
Count: ………………………......................
(In thousands)
30. B.T.: …………………….........................…
31. C.T.: ………………………….....................
32. P.T.: ………………………......................…
33. T. Protein: ………………………................
34. A/G ratio: ……………………….............…
35. F.B.S.: …………………………..................
36. P.P.B.S.: ………………...............…………
37. S. Bilirubin: …………………..........………
797
38. S. Alkaline Phosphatase: ……………..……
39. S.G.O.T.: ………………………..............…
40. S.G.P.T.: ………………………...............…
RADIOLOGICAL INVESTIGATION
42. X-Ray Normal Abnormal
Chest
Parametric investigations (for Kala-azar)

43. Smear stained for demonstration of Leishman Donovan bodies
Positive Negative
1. Aspirates of
a) Bone marrow
b) Spleen
c) Liver
d) Lymph gland
2. Culture of aspirates (for L.D. bodies) of the following
a) Bone marrow
b) Spleen
c) Liver
d) Lymph gland
3. Aldehyde test: ……………………....……..

4. Urea stibamin test: …………………....……
5. R.K. 39 – Kit test: …………………….….
798
ASSESSMENT OF THE EFFICACY OF CERTAIN
HERABL / HERBO-MINERAL DRUGS IN THE
MANAGEMENT OF SLEEPADA (FILARIASIS)
Drug: Study Code:

AND SIDDHA
799
Blank
800
ASSESSMENT OF THE EFFICACY OF CERTAIN AYURVEDIC / HERBO-
MINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA
(FILARIASIS)
I. BACKGROUND
The control of the disease is dependent on the control of mosquito breeding and
elimination of the intermediate host Culexfatigans. It is a global problem. References of this is
found in Ayuervedic text book where in it has been described as a swelling of legs and feet due
to vitiation of Mamsa & Rakta by Kapha Dosha. The detailed description of the disease, covering
clinical features, etio-pathogenesis, the different types, the prognosis and the epidemiological details
of the disease have been provided. The treatment of this disease is Siravedh and Kaphanashak
remedies as described in Charak Samhita.
The characteristic features of the disease are the onset of painful swelling in groins with
fever which gradually descends down to leg & foot. The other parts of the body may be affected
through scrotum in male and breast in female. It is further stated that though the disease may be
due to the involvement of all three doshas, but the predominance of Kapha is obvious in all the
three varities.
This disease is a result of the infestation of filarial parasite, Wuchereria bancrofti. The
frequency of this disease is very much related to the situation where mosquito breeding is more
prevalent. The mosquito Culex fatigans is of crucial importance in the life cycle of filarial parasite.
Ayurveda has also recognized this disease from very earliest time and its description and
therapy have been developed in this system. In Ayurvedic literatures so many herbal &
herbomineral drugs are mentioned viz. Guduchi, Punarnava, Saptaparna, Sharapunkha, Rohitaka
etc., as herbal preparation & Nityodit Rasa, Slipadari Rasa, Kanchnara Guggulu, Gokshuradi
Guggulu etc. as compound herbomineral formulations for the treatment of Sleepada.
References
1. Pandit.Kasinath Sashtri and Dr. Gorakhanath Chaturvedi (1984) Charaka Samhita, (text with
Hindi commentary) XIIth Edition (1984), Published by Chaukabha Vidhya Bhavan, Varanasi,
India.
2. Ambika Dutta Sashtri(1989) Susruta Samhita (text with Hindi commentary) VIIth Edition
Chaukhamba Sanskrit Series Office, Varanasi.
3 Shri Pandit Lal Chandra vaidya (1963), Astanga Hridya ((text with Hindi commentary), Moti Lal
Banarsi Das Publication, Varanasi
4. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998,
Published by McGraw-Hill CompaniesInc.
801
(filaria). The objective of this study are the assessment of some certain herbal / herbo-mineral
compound preparation in the management of Sleepada (filaria) and to assess the importance of
herbal drugs for the management of the challenging problem ‘Sleepada’
II. OBJECTIVE
To assess the efficacy of certain Herbal / Herbo-mineral drugs in the management of
Sleepada (Filariasis)
III. CENTRE
IV. SAMPLE SIZE AND METHOD
Sample size — 200 (100 patients in each group)
Treatment — Herbal / Herbo-mineral drugs
Design of the study — Single blind
Period of Study — 1 month
1. Age – 10 to 60 years.
2. Sex – both male & female
3. Positive case of Filaria
4. Patients having clinical features like Lymphadenities, Lymphangitis, Lymphodema, deformity,
chylurea & fever will be selected irrespective of positive blood smear of microfilaria.
1. Age below 10 yrs & above 60 yrs.
2. Patients having nodular deformity, wound, ulcer, thorny deformity, anthill like deformity,
nutritional odema, odema due to renal problems, cardiac disorder & arthritis disorders.
3. Any other serious systemic disease like – Pulmonary tuberculosis, Jaundice, HIV positive
cases / Malignancy.
4. Pregnancy & Lactating mother.
802
VII. CRITERIA FOR WITHDRAWL
During the course of the trial treatment, if any serious conditions or any serious adverse
events which requires urgent treatment or if patient himself want to withdrawn from the trial and
managed by the principal investigators accordingly.
VIII. ROUTINE EXAMINATION & ASSESSMENT:-
A detailed clinical history and physical examination of each patients will be recorded as
per proforma (from I & IA). The Clinical, Pathological, Biochemical & other Lab investigation will
be done before treatment, during treatment and at the end of treatment will be carried out as per
recorded in the proforma. The assessment of the result will be done on the basis of disappearance
of M.F. and improvement in the clinical features.
X. CRITERIA FOR ASSESSMENT OF THERAPY
Response Assessment Criteria
1. Good Response — 75 % & above relief in symptoms
2. Fair Response — 50 % & 74% above relief in symptoms
3. Poor Response — 25% , 49% & 25% above relief in symptoms.
4. No Response — No relief in symptoms or other wise withdrawn
from the study.
The monitoring of progress of the trial & data analysis will be undertaken by CCRAS,
New Delhi.
XII. ETHICAL REVIEW
1. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
2. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
803
team will report immediately to the PI and Data Monitoring Board 1) any life threatening
written and approved for the treatment of study related adverse events
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial
conduct and laboratory procedures in order to maintain the uniformity.
research Institutes should be conducted at identified reputed labs /Government Institutes
804
ASSESSMENT OF THE EFFICACY OF CERTAIN HERBAL / HERBO-
MINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA (FILARIASIS)
the patient.
Date: ……………… Signature of the subject: …………..........………………
Name …………………………………….........………..
CONSENT BY SUBJECT
in the clinical trial on “Assessment of Safety & Therapeutic Efficacy of Certain Ayuervedic /
Herbal / Herbomineral drugs in the management of Sleepada (Filariasis).”
Date: ……………….. Name of the Subject: …………….............…………..…

Signature or Thumb Impression …………................……
Date: ……………….. Name of Witness: ……………….................….………...

Signature or Thumb Impression: ......……….............……
Relationship …………………………………...............…
805
ENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
AYUERVEDIC / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
The available treatment for Sleepada (Filariasis) in modern medical science like drugs
Hetrazan, Banocide forte etc. have made tremendous success in providing instant or symptomatic
relief but there is recurrent acute exacerbation and remission. In Ayuerveda, many drugs seem to
possess a anti Filarial effect of which certain Ayuervedic / Herbal / Herbomineral drugs that have
been in practice as well as have shown anti Filarial effect have been taken up for the study.
instructions scrupulously. The study will take approximately 3 months to complete. During this
period, you are expected to visit the hospital 6 times for clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic you will undergo a complete
physical examination, ECG and X-ray, Blood, MF test and urine samples will also be taken. This
is to make sure that you are eligible for the study.
If you are found eligible, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor
etc., noticed during the treatment period, this should be noticed to the Principle Investigator.
Advice: (To be given along with Patients Information Sheet)
To avoid trigger factors like allergens if known.

To avoid respiratory irritants like tobacco, smoke and chemicals.
To have warm and fresh food and drinks.
Sympathetic discussion of the problem with the patient and assurance.
806
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
1. Centre: ………………..……….........
3. Name of the subject: ………………………………………….....………………………

4. Address ……………………………………..…………………….....………………….
7. Date of admission:
8. Date of discharge:
9. Group No.: First Second Third Fourth
1. Age – 10 to 60 years.
2. Sex – both male & female
3. Positive case of Filaria
4. Patients having clinical features like Lymphadenities
5. Lymphangitis
6. Lymphodema
7. Deformity
8. Chylurea
9. Fever
807
10. Age below 10 yrs & above 60 yrs
11. Nodular deformity
12. Wound
13. Ulcer and thorny deformity
14. Anthill like deformity
15. Nutritional odema
16. Odema due to renal problems
17. Cardiac disorder
18. Arthritis disorders.
19. Pulmonary tuberculosis
20. Jaundice
21. HIV positive cases/Malignancy
22. Pregnancy & Lactating mother

Date: ………… Signature of the Investigator:.,…………………….
808
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA
(FILERIASIS)
1. Centre: …………….........…........….
3. Sr. No. of the subject: ……………………………...

4. Name of the subject: ……………………………….............……………………………
5. Address ………………………………..…………………….............………………….

10. Educational status: Illiterate 1 Read and Write 2
Primary School 3 Middle School 4
High School 5 College 6
11. Occupation: Desk work 1 Field work 2 Student 3
Housewife 4 Others 5
Indicate nature of work: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12. Income per capita per month (in Rs.)
Less than Rs.5000/- (1) More than Rs.-5000/-
Chief Complaints with duration (in days)

13. Lymphadenitis
809
14. Lymphangitis

15. Lymphoedema
16. Deformity
17. Chylurea
18. Fever
19. Rigor
20. Pain in affected part of the body
21. Heaviness of the affected

part of the body
24. Treatment given so far: Ayurvedic medicine Modern medicine
Unani Homoeopathy
Medicines given…………………….. Result obtained ………………….

25. Factors aggravate the disease / chief complaint:
Drugs Diet Cold climate
Tropical climate Damp climate Sea shore
Others (specify) ……………………………….......……………………………………

Positive factors may be spell out ………………….....…………………………………
26. Factors relieved main complaints:
Drugs Diet Cold climate
Others (specify) ………………………………….....……………………………………

Positive factors may be spell out …………………......…………………………………
810
27. Past illness, having relation with present illness: Yes No
If yes, specify ……………………………………………….....……………………..

Family History Yes (1) No (0)
28. Hypertension
29. Diabetes Mellitus
31. Mental diseases
32. Cancer
33. Cardio vascular disease
34. Tuberculosis
Personal History :
35. Diet: Veg Non-veg Lacto-ova-veg
37. Emotional stress: Yes No
38. Bowel habit Regular Constipation
Hard stool Loose stool
39. Prakriti: Vataja Pittaja Kaphaja
Vata-Kaphaja Vata-Pittaja Pitta-Kaphaja
Sannipataja
40. Mans Prakriti: Satva Rajas Tamas
Satva-Rajas Stava- Tamas Rajas-Tamas
Sama
Yes (1) No (0)

41. Tobacco smoking exposure
If yes specify whether it aggravated the symptoms or not: ……………….....................…………
811
42. Tobacco chewing
If yes specify: (a) Quantity ____________

(b) Total duration in years: ____________
43. Betel chewing
44. History of alcohol intake:
Occasional :1
Regular :2
Never :3
Physical Examination:
47. Height (cm): ____________

48. Weight (kg) ____________
49.
[
B.M.I Weight (kg.)
Height (meters) 2 ] ____________
50. Pulse (per min) ____________

51. Blood Pressure (mm Hg) ____________
52. Body temperature (o F) ____________
54. Cyanosis ____________
55. Clubbing nails ____________
56. Edema ____________
57. Cynosis
812
58. Anaemia
59. Jaundice
60. Pigmentation
62. Deformities
63. Lymphadenopathy
Normal Abnormal
66 C.V.S. (with chest)
If ‘abnormal’ specify abnormalities …………....................................................…………

67 C.N.S.
If ‘abnormal’ specify abnormalities ……………...............................................……………

68 Digestive system
If ‘abnormal’ specify abnormalities ……………………............................................……

69 Uro-Genital system
If ‘abnormal’ specify abnormalities ……………………….............................................…
Local Examination of the affected part(s)

(As per criteria laid down vide annexure – 1)
S.No. Part(s) affected Swelling Tenderness Appearance /
Colour/
Consistency
1.
2.
3.
4.
5.
6.
813
Samprapti (Pathogenesis) of the disease according to Ayurvedic concept
64. Anubandhya dosha Vata Pitta Kapha
65. Anubandha dosha Vata Pitta Kapha
66. Avaraka dosha Vata Pitta Kapha
67. Ksheena dosha Vata Pitta Kapha
68. Ksheena dhatu Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Ojas
69. Dushya (Involved) Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Ojas
70. Stages of disease (Roga Kriya Kala) Sanchaya Prakopa
Prasara Sthana Sanshray Vyakti
Bheda
Srotas Pareeksha
71. Prana vaha srota
Abhikshna Swasa (Chyne stroke breathing) 3
Kupita Swasa (Vitiated breathing) 4
72. Udakavaha srota
Talu sosha (Dryness of palate) 3
814
Kantha sosha (Dryness of throat) 4
Kloma sosha (Excessive thirst) 5
Trishna (Thirst) 6
73. Annavaha srotas
Aruchi (Anorexia) 2
Hrillasa (Water brash) 3
Tandra (Stupor) 5
Jwara (Fever) 7
Pandu (Anaemia) 8
Avasada (Depression) 9
Klaibya (Loss of libibo) 10
Pidika (Boils) 1
Mukha Paka (Stomatitis) 3
815
Charma roga (Skin disease) 5
Kamala (Jaundice) 6
Arubuda (Tumour) 1
Alajee (Phlyctenular conjunctivitis) 2
Gandamalaa (cervical lymphadenitis) 3
Upji (Epiglotis) 4
Tandra (Stupor) 4
Alasya (Lethargy) 6
Adhyasthi (Hypertrophy of bone) 1
Dantashoola (Toothache) 3
Asthi shoola (Bone pain) 4
Kesha, loma, nakha, samshru vikara 5
79. Majja vaha srotas
816
Moorchh (Syncope) 3
80. Shukra vaha srotas
Klaivya (Sterility / impotence) 1
Santana Vikriti (Congenital deformity of the children) 4
81. Manovaha srotas
Manovibramsha 1
Budhivibramsha 2
Sanjna Vibhramsha 3
Smritivibhramsha 4
Bhaktivibhramsha 5
Sheelavibhramsha 6
Chesta Vibhramsha 7
Acharavibhramsha 8
Vandhyatva (Sterility) 2
Bahumutra (Polyuria) 1
Atibadhata (Urination with obstruction) 2
Prakop-mutra (Defective Urination / Difficulty 3
in micturition)
Aabhikshna (Constant / repeated urination) 5
817
Bahulamutrata (Urine with prostatic secretion) 6
Sashoola amutrata (Painful micturition) 7
Alpaalpa Pureesha (Scanty defecation) 1
Sashoola Pureesha (Painful defecation) 2
Atidrava Pureesha (Diarrhoea) 3
Atigrathita Pureesha (Scybala) 4
Aswedana (Loss of perspiration) 1
Angaparidaha (Burning sensation in the body) 5
86. Provisional Diagnosis
87. Final Diagnosis
88. Medical Management
89. Principal drug therapy
Dose
Vehicle
Diet
90. Summary of finding
Date: ……………… Signature of Investigator
818
CASE REPORT FORM – III CLINICAL ASSESMENT
1. Centre: ……………….……….
3. Sr. No. of the subject: ……………………….……..

4. Name of the subject: ………………………………………………………................…
5. Address ………………………………..………………………………………................
INITIAL Weeks after starting therapy

1 2 3 4
5 6
1. Clinical Parameters
a). Lymphadenitis
(i)
(ii)
(iii)
(iv)
b). Lymphangitis
(i)
(ii)
819
(iii)
(iv)
c). Lymphoedema
(i)
(ii)
(iii)
(iv)
d). Deformity (Score with measurement in cms.)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
e). Pain
(i)
(ii)
(iii)
(iv)
f). Tenderness
(i)
(ii)
(iii)
(iv)
g). Fever
(i)
820
(ii)
(iii)
(iv)
h). Rigor
(i)
(ii)
(iii)
(iv)
2. Laboratory Investigation
i) Microfilaria
ii) Chyle
iii) M.F. Count per 20 Cu.mm
In night blood/ DECP Test
iv) Immunoglobulins
Date: …………….. Signature of the Investigator: ………………….....……….
821
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………............…….
3. Sr. No. of the subject: ……………………………..

4. Name of the subject: ……………………………………………............………………
5. Address ………………………………..……………………………….............……….
ADVERSE EVENTS
1 2 3 4
Adverse
Experience
822
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
823
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
824
1. Centre: ………………..........……….
3. Sr. No. of the subject: ……………………………..

4. Name of the subject: ………………………………………...............……….…………
5. Address ………………………………..……………………………..............………….
Lab. Investigation Before treatment During treatment after

First weeks Second weeks Third weeks Fourth week
8. Date of sample taken
9. Urine
i) Microfilaria
ii) Solublity in ether
iii) Chyle
10. Blood
ii) M.F. Count per 20 Cu.mm.
in night blood smear / DECP Test.
iii) Hb%
iv) T.L.C.
v) D.L.C.
Polymorph : …………………………
825
Lymphocyte : …………………………
Eosinophil : …………………………
Basophil : …………………………
Monocyte : …………………………
vi) E.S.R.
vii) Immunoglobulin
Date: ……………… Signature of the investigator: …………………
826
HAEMATOLOGICAL DISORDERS
SECTION - XIV
827
Blank
828
SELECTED DRUGS IN IRON DEFICIENCY ANAEMIA
Drug: Study Code:

AND SIDDHA
829
Blank
830
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
I. BACKGROUND
Iron Deficiency Anaemia1 (which is described under the disease Panduroga in Ayurveda)
is a worldwide problem with the highest prevalence in developing countries. It is found especially
among women of childbearing age, young children and during pregnancy & lactation. Detailed
description concerning the etiology, pathogenesis classification and management of Anaemia
(Panduroga) is available in classical literatures of Ayurveda.
Iron Deficiency is the most common cause of nutritional Anaemia; others are foliate &
Vitamin B-12 deficiency. Iron deficiency can arise either due to inadequate intake or poor
bioavailability of dietary iron or due to excessive loss of iron from the body. The poor
bioavailability is considered to be major reason for widespread iron deficiency. Women lose a
considerable amount of iron in menstruation. Some of other factors leading to anaemia are
intestinal parasites (hookworm etc.) & malaria.
Current Medical therapy –Prospects
In conventional medicine, various forms of iron viz. Ferrous sulfate, ferrous fumerate etc.
are commonly prescribed, but these therapies have their noted adverse effects e.g. nausea,
vomiting, abdominal pain, diarrhoea /constipation.
Owing to the gravity of the situation, need is felt for search of safe /effective Ayurvedic
oral dosage forms to improve the haemoglobin level in iron deficiency Anaemia. Keeping the
gravity of the situation and the public health needs in view, the council has initiated scientific
studies on Dhatri Lauha, a promising formulation that is being successfully prescribed by
Ayurvedic physicians without any side effects since centuries. The formulation has been
standardized after formulating SOPs besides safety / toxicity evaluation.
The formulation is found safe and biological activity studies revealed significant haematenic
effect. (Unpublished data of CCRAS) The objective of current study is to assess clinical safety
and efficacy through measurable objective parameters.
Reference:
1. Charaka, 1962, Charaka Samhita, Chikitsa Sthana Chapter– 16, Choukhamba Sanskrit Series, Varanasi
2. A textbook of Preventive and Social Medicine, PARK 15th Edition, 403-404.
3. John W. Adamson, Harrison’s Principles of Int. Medicine, P.660-665.
4. B.C. Mehta, API Text Book of Medicine, 5th Edition reprint, 983-984.
5. Harrisson’s Principles of Internal Medicine, Volume 1,15th Edition.
831
II. OBJECTIVES
1) Observe the effect of Dhatri lauha on haematological parameters viz. Hb%, MCV,
MCHC, TIBC, Serum iron content and Serum ferritin in Iron Deficiency Anaemia
subjects.
2) Observe the clinical safety of Dhatri lauha in Iron Deficiency Anaemia subjects.
III. CENTRE
CCRAS identified Institutes.

Sample size : 40 subjects per Centre
Trial Drug /Dosage /Duration : Dhatri Louha 500 mg. (one capsule) twice daily
after meal for forty five (45) days with warm
water.
In the pre-treatment phase de-worming should be done with the prescription of one
chewable tablet stat of 400 mg. Albendazole, 7 days before the treatment phase to all cases
included in the trial.
Total period of the study : 1 year (recruitment of Subjects upto the end of 6th
month , continuation of trial therapy till end of 8th
month, last 4 months for compilation of data and
statistical analysis)

1 Age between 15 to 60 years
2 Haemoglobin level between 8 to 10 gm /dl.
3 Serum iron content < 50 ìg /L
4 S. Ferritin < 30 ìg /L
5 MCHC < 34 g/dl
6 MCV <80fL.
7 Peripheral smear of blood shows hypochromic / microcytic anaemia
832
2. Pregnancy and lactation
3. Severe Renal / Hepatic/ Cardiac disease
4. Any continuing blood loss e.g. Haematemesis, Melaena, bleeding piles etc.
5. Dimorphic anaemia

events which requires urgent treatment or if subjects themselves want to withdraw from the study,
such subjects may be withdrawn from the trial.

recorded as per case record form I & II. Clinical and physiological assessment in form III and
laboratory investigations in forms IV A, B, C, D will be done at 0, 15th, 30th & 45th days
respectively. Consolidated data on periodical observation will be recorded in case record form V
at 45th day.

Changes in haemoglobin % (Cyanomethamoglobin method), MCV, MCHC (Mean
Corpuscular Haemoglobin Concentration), Serum Iron and Serum Ferritin levels will be considered
for assessing the outcome of the treatment on 0, 15th, 30th and 45th day. The safety parameters
(liver and kidney function tests) will be assessed at 0 and 45th day.

analysis.
833
Ethical Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along with
project proposal for approval by IEC.
Hqrs will carefully monitor the data and side effects during the period of study and put in a place
where by prompt reporting of adverse events occur and take appropriate steps in case of any
adverse events occur. The data will be reviewed for every 20 participants included into the study
and administered the trial drugs. The research team will report immediately to the PI and Data
Monitoring Board if any life threatening conditions whether they are perceived to be study related
or not. The Board decides whether the adverse effects warrant discontinuation of the study
protocol. Protocols will be written and approved for the treatment of study related adverse events.

A consolidated amount of Rs. _____ /- per visit i.e., on the 1st day of recruitment after
screening, 15th day, 30th day and 45th day (4 times)

personnel involved in the multicentric trial at CCRAS Hqrs., New Delhi. The investigators and

The Laboratory Investigations (Pathological/Biochemical etc.), which are not available at
research institutes should be conducted at identified reputed Labs /Government Institutes under
834
the subject.
Date: ___________ Signature of the investigator: _______________________
Name ________________________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician about the purpose of
the clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
this study.
in the clinical trial on “Multicentric Open Clinical Trial of Selected (Dhatri Lauha) Drugs in
Iron Deficiency Anaemia.”
Date: _____________ Name of subject: _________________________

Signature or Thumb impression: ______________
Date: _____________ Name of witness: _________________________

Relationship: _____________________________
Translate into regional language
835
DEFICIENCY ANAEMIA

Iron Deficiency Anaemia is a worldwide problem with the highest prevalence in developing
countries. It is found especially among women of childbearing age, young children and during
pregnancy & lactation. In conventional medicine various forms of iron viz. Ferrous sulfate, ferrous
fumerate etc. are commonly prescribed, but these therapies have their certain limitations.
The council has initiated scientific studies for revalidation (through measurable objective
parameters) of certain classical formulations that are being successfully prescribed by Ayurvedic/
Siddha physicians without any side effects since centuries. In scientific studies no adverse effects
are reported.
Beneficiaries and benefits

Subjects suffering from Iron Deficiency Anaemia, after free consultation and screening by
physician, if found suitable shall be provided free medicines & laboratory investigations etc. for
certain time. Consolidated amount for traveling / wage loss shall be provided to the suitable
individuals on each visit till completion of the study.

you are expected to visit the hospital three times i.e. on 0th, 8th, 15th, 30th and 45th day for clinical
Translated into regional language
836
DEFICIENCY ANAEMIA
BEFORE TREATMENT
1. Code No. (of clinical trial): 01

2. Center: ____________________
3. Subject Name__________________________________
4. Sex Male Female
5. Date of birth : Age (in years):
_____________________________________________________________________
_____________________________________________________________________

2. Hemoglobin level between 6 to 10 gm / dl
3. Serum iron content < 50 ìg /dl
4. S. Ferritin < 30 ìg /L
5. MCHC < 34 g/dl
6. MCV<80 fl
7. Peripheral smear for blood shows
8. Hypochromic & Microcytic anaemia

10. Pregnant / lactating woman
837
11. Severe Renal/Hepatic/Cardiac disease*
12. Any continuing blood loss e.g. hematemesis,
melena and bleeding piles etc.
13. Dimorphic anaemia
14. History of Chronic Infections

If enrolled:-
Subject Sl. No.: ____________ No. of strips issued__________
Date: _______________ Signature of the Investigator: ________________

Name of the Investigator: ___________________
* Normal range of values for Sl. No. 17

a). S. Bilirubin
i. Total 0.3 – 1.0 mg/dl
ii. Direct 0.1 – 0.3 mg/dl
b). SGPT 0 – 35 IU/L
c). SGOT 0 – 35 IU/L
d). S. Alkaline phosphatase 30 – 120 IU/L
e). S. Proteins (Total) 5.5 – 8.0 g/dl
i. Albumin 3.5 – 5.5 g/dl
ii. Globulin 2.0 – 3.5 g/dl

f). Blood urea 15 – 40 mg/dl
g). S. Creatinine < 1.5 mg/dl
838
DEFICIENCY ANAEMIA
CASE REPOTR FORM II – HISTORY
2. Center: ____________________
3. Sr. No. of the Subject: _______________________________

4. Subject Name: ______________________________________
5. Sex Male Female
__________________________________________________
__________________________________________________
8. Educational status: Illiterate 1 Read and Write 2
Primary School 3 Middle School 4
High School 5 College 6
9. Annual Income of the family Rs.
10. Total number of members sharing the income:
If Field work, indicate nature of work: ________________________________________
839
Yes (1) No (0) If Yes Duration (in days)
12. Weakness
13. Fatigue
14. Palpitation
15. Effort intolerance
16. Breathlessness
17. Swollen feet
18. Asymptomatic

20. Previous episodes Yes 1 No 2
PERSONAL HISTORY:
Addictions: Yes (1) No (0)
22. Alcohol:
23. Tea / Coffee more than 4 times a day
24. Tobacco
If yes: Chewing 1 Smoking 2 Both 3

25. Diet Vegetarian 1 Non-vegetarian 2
26. Menstrual history: Regular 1 Irregular 2
If irregular, Specify___________________________________
Duration of menstruation Up to 5 days 1 5-7 days 2 More than 7 days 2
Quantity Normal 1 Abnormal 2
If abnormal, specify__________________________________
840
27. Sharirik Prakriti: Vata 1 Pitta 2 Kapha 3
Sannipataja 7
PHYSICAL EXAMINATION:
30. Body weight (Kg.) __________
31. Height (cm.)_________
32. Body temperature (oF)____________
33. Blood pressure (in sitting posture of right upper limb) –
Systolic_______mm/Hg
Diastolic _______mm/Hg
36. Pallor
37. Koilonychia
38. Lymphadenopathy
SYSTEMIC EXAMINATION:
39. CVS with chest
If Abnormal, specify abnormalities________________________________
40. CNS
If abnormal, specify abnormalities________________________________
841

Liver
Spleen

46. Anubandh dosha
47. Avraka dosha
48. Ksheena dosha
49. Ksheena dhatu: Rasa 1 Rakta 2 Mamsa 3 Meda 4

Asthi 5 Majja 6 Shukra 7 Oja 8
50. Dusya Rasa 1 Rakta 2 Mamsa 3 Meda 4
Asthi 5 Majja 6 Shukra 7 Oja 8
Date: __________________ Signature of the Investigator: ____________________
Name of the Investigator: ______________________
842
DEFICIENCY ANAEMIA
CASE REPORT FORM – III PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(0th day)
2. Center: _______________________
3. Sr. No. of the Subject: ____________________________

4. Subject Name: ___________________________________
5. Sex Male 1 Female 2

Yes (1) No (0) If yes, Duration (in days)
8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
13. Swollen feet
Yes (1) No (0)
14. Asymptomatic
15. Other Associated Symptoms
843
If yes, specify: ___________________________
___________________________
___________________________
Date: ______________ Signature of Investigator: _________________
Name of Investigator: ____________________
844
DEFICIENCY ANAEMIA
ASSESSMENT
(On 15th Day)

2. Center: ____________________
3. Sr. No. of the Subject: ___________________________

4. Subject Name: __________________________________

8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
13. Swollen feet
14. Asymptomatic
If yes, specify: ___________________________

___________________________
845
Adverse Reactions: Present (1) Absent (0) If yes, Duration (in days)
17. Nausea
18. Diarrhoea
19. Skin rashes
20. Any other adverse complaints/observations specify______________________________

Continuing 1
Drop out 2 Reason: _____________________________________________
Death 3 Cause: ______________________________________________
If continuing, No. of blisters issued: __________________________________________
Date: ______________ Signature of Investigator ____________________
Name of Investigator ______________________
846
DEFICIENCY ANAEMIA
ASSESSMENT
(On 30th Day)
2. Center: _______________________
3. Sr. No. of the Subject: ____________________________

4. Subject Name: ___________________________________

8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
13. Swollen feet
14. Asymptomatic

If yes, specify: ___________________________
___________________________
847
17. Nausea
18. Diarrhoea
19. Skin rashes
20. Any other adverse complaints/observations specify_______________________________

Continuing 1
Drop out 2 Reason: ______________________________
Death 3 Cause: _______________________________
If continuing, No. of blisters issued: __________________________
Name of Investigator ____________________
848
DEFICIENCY ANAEMIA
ASSESSMENT
(On 45th Day)

2. Center: _______________________

4. Subject Name: __________________________________

8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
13. Swollen feet
14. Asymptomatic
If yes, specify: ___________________________

___________________________
849
17. Nausea
18. Diarrhoea
19. Skin rashes
20. Any other adverse complaints/observations specify_______________________________

Completed 1
Drop out 2 Reason: _____________________________
Death 3 Cause: ______________________________
Name of Investigator ____________________
850
DEFICIENCY ANAEMIA
(0th Day)

2. Center: ____________________
4. Subject Name: __________________________________
URINE EXAMINATION
Routine
8. Sugar
9. Albumin
10. Bile Salts
11. Bile Pigments
Microscopic
12. RBC
13. Pus Cells
14. Epithelial Cells
15. Any others _________________________________________
851
STOOL EXAMINATION
Routine
16. Occult Blood
Microscopic
17. Ova/Cyst
BLOOD
18. TC (Cells/Cu. mm.) _______________
19. DC: P ______ (%) L ______ (%) E ______ (%) M ______ (%) B ______ (%)
20. ESR (mm / 1st hour.) _________________
21. M.C.H.C. (g/dl)______________________
22. M.C.V. (fl)__________________________
23. Serum iron (ìg/dl)_____________________
24. Serum ferritin (ìg/L) ___________________
25. Hb (g/dl) (Cyanomethamoglobin method) _____________________________________
26. PCV (%) _________________
27. TIBC (μg/dl) ____________
28. General Blood Picture for morphology of RBC ______________________________
Normocytic Normochromic (1) Normocytic Hypochromic (2)
Macrocytic Normochromic (3) Macrocytic Hypochromic (4)
Microcytic Hypochromic (5)

29. Serum Bilirubin
Total (mg/dl) ________
Direct (mg/dl) _________
852
30. SGPT (IU/L) ________
31. SGOT (IU/L) ________
32. S. Alkaline phosphatase (U/L) ________
33. S. Proteins (Total) (g/dl) _____________
34. Albumin (g/dl) ________
35. Globulin (g/dl) ________
36. Blood urea (mg/dl) __________
37. S. Creatinine (mg/dl) _________
Date: _____________ Signature of the Investigator ______________
Name of the Investigator _________________
853
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN
IRON DEFICIENCY ANAEMIA.
CASE REPORT FORM IV-B – LABORATORY INVESTIGATIONS
(15th Day)

2. Center: _______________________

4. Subject Name: __________________________________
8. M.C.H.C. (g/dl)____________________
9. M.C.V. (fl)________________________
10. Serum iron (ìg/dl)___________________
11. Serum ferritin (ìg/L) _________________
12. Hb (g/dl) (Cyanomethamoglobin method) _______
13. PCV (%) _______________
14. TIBC (ìg/dl) ___________
15. General Blood Picture for morphology of RBC ____________________
Date: _____________ Signature of the investigator ___________________

Name of the investigator _______________________
854
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN
IRON DEFICIENCY ANAEMIA.
CASE REPORT FORM IV-B – LABORATORY INVESTIGATIONS
(30th Day)
2. Center: _______________________

4. Subject Name: __________________________________
8. M.C.H.C. (g/dl)____________________
9. M.C.V. (fl)________________________
10. Serum iron (ìg/dl)___________________
11. Serum ferritin (ìg/L) _________________
12. Hb (g/dl) (Cyanomethamoglobin method) _______
13. PCV (%) _______________
14. TIBC (ìg/dl) ___________
15. General Blood Picture for morphology of RBC ____________________
Date: _____________ Signature of the investigator ____________________

Name of the investigator ________________________
855
DEFICIENCY ANAEMIA
(45th Day)
2. Center: ____________________

4. Subject Name: __________________________________
URINE EXAMINATION
Routine
8. Sugar
9. Albumin
10. Bile Salts
11. Bile Pigments
Microscopic
12. RBC
13. Pus Cells
15. Any others: ___________________________________
856
STOOL EXAMINATION
Routine Absent (0) Present (1)
16. Occult Blood
Microscopic
17. Ova/Cyst
BLOOD
18. TC (Cells/Cu. mm.) _______________
19. DC: P _____ (%) L _____ (%) E _____ (%) M _____ (%) B _____ (%)
20. ESR (mm / 1st hour.) __________
21. M.C.H.C. (g/dl)________________
22. M.C.V. (fl)______________________
23. Serum iron (ìg/dl)_____________________
24. Serum ferritin (ìg/L) __________________
25. Hb (g/dl) (Cyanomethamoglobin method) ____________________
26. PCV (%) ___________
27. TIBC (μg/dl) ___________

29. Serum Bilirubin
Total (mg/dl) ________
Direct (mg/dl) _________
30. SGPT (IU/L) ________
857
31. SGOT (IU/L) ________
32. S. Alkaline phosphatase (U/L) ________
33. S. Proteins (Total) (g/dl) _____________
34. Albumin (g/dl) ________
35. Globulin (g/dl) ________

36. Blood urea (mg/dl) ________
37. S. Creatinine (mg/dl) ________
Date: _____________ Signature of the Investigator ____________________
Name of the Investigator _______________________
858
DEFICIENCY ANAEMIA
CASE RPORT FORM – V
2. Center: _______________________

4. Subject Name: __________________________________
Sl Subjective/ objective 0 day/BT 15th day 30th day 45thday/AT
Yes No Yes No Yes No Yes No
(1) (0) (1) (0) (1) (0) (1) (0)
1. Weakness
2. Fatigue
3. Palpitation
5. Breathlessness
6. Swollen feet
7. Other Associated Symptoms if Any [Specify]
Adverse reactions
8. Burning sensation in Not applicable
abdomen
859
9. Nausea Not applicable
10. Diarrhoea Not applicable
11. Skin rashes Not applicable
12 TC (Cells/Cu. mm.)
DC (%) 13. P 13. P
14. L 14. L
15. E Not applicable Not applicable 15. E
16. M 16. M
17. B 17. B
18 ESR (mm / 1st hour.) Not applicable Not applicable
19 M.C.H.C. (g/dl)
20 M.C.V. (fl)
21 Serum iron (ìg/dl)
22 Serum ferritin (ìg/L)
23 Hb (g/dl)
(Cyanomethamoglobin
method)
24 PCV (%)
25 TIBC (ìg/dl)
26 General Blood
Picture for
morphology of RBC
S. Bilirubin
27. Total (mg/dl)
28. Direct (mg/dl)
29. SGPT (IU/L)
Not applicable Not applicable
30. SGOT (IU/L)
860
31. S. Alkaline
phosphatase (U/L)
32. S. Proteins (Total)
(g/dl)
33. Albumin (g/dl)
34. Globulin (g/dl)
36. S. Creatinine (mg/dl)
Urine Examination
Routine
37. Sugar
38. Albumin (gm/dl) Not applicable Not applicable
39. Bile Salts

40. Bile Pigments
Microscopic
41. RBC
42. Pus Cells
44. Any others
Stool Examination
45. Occult Blood Not applicable Not applicable
46. Ova/Cyst Not applicable Not applicable

861
Completed 1
Drop out 2 Reason: ______________________________
Died 3 Cause: _______________________________
Date: ______________ Signature of the investigator _____________________
Name of the investigator: _______________________
862
TO EVALUATE THE SAFETY AND EFFICACY OF
AYUSH-RP IN SICKLE CELL ANEMIA
Drug: Study Code:

AND SIDDHA
863
Blank
864
TO EVALUATE THE SAFETY AND EFFICACY OF AYUSH-RP IN SICKLE
CELL ANAEMIA
I. BACKGROUND
Sickle Cell Anaemia (SCA) is a chronic hemoglobinopathy characterized by frequent
episodes of painful arises, widespread tissue infarcts causing multisystem dysfunction, chronic
anaemia, increased susceptibility to infection & growth retardation (Francklin Bunn 1987). There
are many genotypes of sickle hemoglobinopathies e.g. Sickle Cell Anaemia, Sicke Cell traint (HbS
trait), S/ß0 thalassemia/Sß + thalassemia haemoglobin SC, SD, SE. The prototype of Sickle
hemoglobinopathy is Sickle Cell anemia, is the homozygous state for HbS. The Sickle Cell Anemia
is caused by a mutation in the ß-globin gm that changes the sixth amino acid from Glutamic acid
to valine HbS ß2ß26Glu’→Val). Hypoxia, pyrexia & acidosis aggravate sickling. The precipitating
cause is not always detectable. The Clinical features of Sickle Cell disorder have got maximum
resemblance with Raktadusti, Jeernajwara, hepatomegaly, splenomegaly) rather than Pandu
Roga as described in Compendiums of Ayurvedic System of Medicine. A variety of drugs like
urea, zinc, cyanate, vitamin-E, magnesium sulphate, cietidil, 5 azamutidine, hyperbolic oxygen and
pentoxifyline, etc. have all produced equivocal results. Recently antibiotic prophylaxis with
splenectomised patient, vigorous hydration with narcotic analgesic. Exchange blood transfusion,
hydroxurea, S-Arginine, folic acid supplements, clotirimazole are the mainstay of treatment but
recent treatment proved to be expensive & toxic side effect (Bone marrow toxicity of
hydroxyurea). Bone marrow transplantation is most effective treatment in modern medicines but it
is too expensive. Therefore, this study aims to evaluate the effect of Ayurvedic drug which has low
cost, probably low toxicity and probably that lessons the sickle cell crises.
II. AIM & OBJECTIVES
The objectives will be to evaluate the changes in frequency of Sickle Cell crisis with
AYUSH-RP in Sickle Cell Anaemia.
References
1. API, Textbook of Medicine 5th Edition Reprint 1994 P.997-998
2. Davidson’s Principle and Practice of Medicine 19th Edition p.926-927
3. Harrison’s is Principle of Internal Medicine 15th Edition 669-671
4. Hemoglobin level and prevention of repeated Blood transfusion in sickle cell disorders with
classical Ayurvedic formulation, R.K.Panda. JRAS XVII, 47-55.
865
III. CENTRES -
Sample size: 20 subjects per centre.
Drug:
(i) Drug/Dosage/Duration: Ayush-RP 500 2 cap. BID with lukewarm water for six
months before food for six months.
(ii) Design of the study - Open trial (Pilot study)
Duration of the study – 6 months with drug and without follow up for another six
months.
Total period of the study - 2 years. (Recruitment for nine months. Treatment and follow
up for one year and three months for statistical analysis).
1. Age >5 years with or without fever, muscular pain in both extremities & Hepatomegaly.
2. Patients having hemoglobin > 5 gm%.
3. Diagnosed Patients on the basis of peripheral smear for sickling & Haemoglobin
Electrophoresis.
4. Patient with Hb% < 5 gm%.
5. Patient with end stage renal disease.
6. Patient with documented infection.
7. Severe liver dysfunction.
8. Patient with acute chest syndrome (Like Respiratory failure, pulmonary edema/ embolism/
infarction.
9. Patient on bone marrow transplant/renal transplant.
During the course of trial if any serious condition (Liver, kidney and lungs function
deteriorates) develops which requires urgent treatment such subject may be withdrawn from trial
& managed by principle investigator accordingly.
866
start of the treatment and then monthly during treatment period and follow up period for 6 month.
The laboratory investigations will be recorded before drug administration, at the start of treatment
then monthly during treatment period and follow up.
IX. CRITERIA FOR ASSESSMENT OF RESULT OF TREATMENT
METHOD OF ASSESSMENT:
Two parameters subjective and objective were used for assessment of progress:
i. SUBJECTIVE PARAMETERS: The symptoms e.g. fever, weakness, abdominal
discomfort & pain in extremities observed during the follow up period were grades
0,1,2,3 on the basis of severity and duration. The improvement was confirmed from
favourable shift grade of each sign & symptoms from grade 3-0 as follows.
SUBJECTIVE SYMPTOMS GRADES

Fever 0,1,2,3
Weakness 0,1,2,3
Abdominal discomfort 0,1,2,3
Pain in the extremities 0,1,2,3
ii. OBJECTIVE PARAMETERS:

i. Increase level of Haemoglobin.
ii. Change of size of liver and spleen.
iii. Changes of frequency of crisis.
XI. STATISTICAL ANALYSIS:
On the basis of above mentioned subjective and objective parameters result will be
analyzed using appropriate statistical parameters.
XII. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visits by Monitoring Unit and Staff of
collaborating agencies (Department of ISM&H and ICMR, Hqrs, New Delhi.) regularly.
Data analysis will be undertaken at the Monitoring Unit/Department of ISM & H.
867
XIII. ETHICAL REVIEW:
868
TO EVALUATE THE SAFETY AND EFFICACY OF AYUSH-RP IN SICKLE
CELL ANEMIA
CONSENT FORM
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending Physician, the purpose of the
this study.
I, exercising my free power of choice, herby give my consent to be included as a subject
in the clinical trial of Ayurvedic drug in Sickle Cell Anaemia.
Relationship ___________________________________
869
PROTOCOL TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN SICKLE
CELL ANAEMIA

Sickle Cell Anaemia (SCA) is a chronic hemoglobinopathy characterized by frequent
episodes of painful crisis, widespread tissue infarcts causing multisystem dysfunction, chronic
anemia increased susceptibility to infection and growth retardation. It is caused by mutation in the
B-globin of haemoglobin. In Indian, it is more prevalent in tribal area of Orissa, Madhya Pradesh,
Maharashtra. It occurs in both sexes occurrence at the ages of 3 to 30 yrs. There are various
modern drug available but recent treatment proves to be expensive and have toxic side effects.
Therefore, this study aims to evaluate the safety & efficacy of Ayurvedic drug in Sickle Cell
Anaemia which has low cost & probably low toxicity (the symptoms of gastrointestinal tract e.g.
Nausea, vomiting, diarrhoea, any abdominal discomfort if any).
instructions scrupulously. The study will take 6 month treatment period. During this period you
have to visit at beginning of treatment and monthly during treatment period and follow up for
clinical assessment and Lab. Investigation.
Before you start of treatment clinical assessment and the biochemical test will be carried
out. If your diagnosis is confirmed and you will be a fit case you will be subjected to this study
for the period of one year you will be supplied with the sufficient quantity of medicine to last until
your next visit and once in every months the clinical assessment and blood test will be repeated to
assess therapeutic efficacy of drug.
870
PROTOCOL TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN SICKLE
CELL ANAEMIA
CASE REPORT FORM PART-I – SCREENING
1. Centre: ………………..……….
3. Patient No.
4. Name of the patient: ………………………………........ Age .................. Sex .................
5. Address : ..............................................................................................................................
CRITERIA FOR INCLUSION
6. Age >5 years with or without fever, muscular pain in both extremities & Hepatomegaly.
7. Patients having haemoglobin >5 gm%.
8. Diagnosed Patients on the basis of peripheral smear for sickling & Haemoglobin Electrophoresis.
CRITERIA FOR EXCLUSION
9. Patient with Hb% < 5 gm%
10. Patient with End stage renal disease.
11. Patient with documented infection.
12. Severe liver dysfunction
13. Patient with acute chest syndrome (Like Respiratory failure, pulmonary edema/ embolism/
infarction.
12. Patient on bone marrow transplant/renal transplant
If yes to 4-6 & no to 7-12, then patient should be included into the study.
871
PROTOCOL FOR TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN
SICKLE CELL ANAEMIA
CASE REPORT FORM PART-II HISTORY PROFORMA
1. Centre: ………………..……….
3. Patient No.
4. Name of the patient: ………………………………........ Age .................. Sex .................
5. Address : ..............................................................................................................................
6. Date of admission: Date of Discharge :
9. Total income of the family in rupees
11. Religion: Hindu Muslim Sikh
Christian Parsi
12. Marital status: Married Unmarried Divorcee/separated
872
Chief Complaints with Duration (in days) Present Absent Duration
13. Fever
14. Weakness
15. Pain in hip and shoulder joints.
16. Any other joint pains.
17. Pain in extremities

back, hand, foot, muscle
18. Abdominal discomfort
19. Yellowish Eye, yellow colour urine
20. Any altered sensation in the limbs
21. Chest pain (pleuritic)
22. Any rash
23. Priapism
24. Any C/o growth retardation.
25. Any vision disturbances
26. Any other complaints specify.
Past history of illness: History of bleeding from the nose and history of conversion, giddiness
fainting, attack, CVA, if any
28. Previous episodes Yes No
29. Type of fever-periodicity 24 hrs. 48 hrs.
873
31. Treatment given so far Ayurvedic medicine Modern medicine
Unani Homoeopathy
Siddha Mixed
Spell out the medicine and results obtained
_______________________________________________________________________
_______________________________________________________________________
Personal History :
Yes No
32. Smoking
33. Obesity
34. Non-Vegetarian
35. Alocholic
36. Prakriti
Vataj Pittaj Kaphaj
Vataja-Kaphaja Vataj-Pittaja Pittaja-Kaphaja
Sannipataja
37. Manas Prakriti
Sattava Rajas Tamas
Sattava-Rajas Rajas-Tamas Sattva-Tamas
Sama
40. Body weight (in Kgs.)
874
41. Body temerature :
42. Blood pressure (Systolic/Diastolic)
43. Pulse
44. Respiration
Present Absent
45. Cynosis
46. Anaemia
47. Jaundice
48. Pigmentation
50. Ulcer
51. Lymphadenopathy
52. Rash/erythema, pallor
Normal Abnormal
53. C.V.S. with chest
If abnormal, specify abnormalities : ......................................................................................
54. C.N.S.
875
If abnormal, specify abnormalities: _________________________________
58. Liver Palpable Not palpable
Size in cm.
59. Spleen Palpable Not palpable
Size in cm.
Present Absent
60. Tumour/Lump
61. Portal ascites
SAMPRAPTI (PATHOGENESIS) OF THE DISEASE ACCORDING TO AYURVEDIC

CONCEPT
Vata Pitta Kapha
63. Anubandh dosha
Avrak dosha
Ksheen dosha
Ksheen dhatu Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Oja
Dusya Rasa Rakta Mamsa
Meda Asthi Majja
Shukra
876
{}
Sthansamshraya Vyakti Bheda
65. Srotas Pareeksha
Pranvaha Srotas
Alpa Alpa Swasa (Shortened breathing)
Atisrama Swasa (Increased respiration rate)
Abhiksham Swasa (Chyne stroke breathing)
Kupit Swasa (Vitiated breathing)
Sashula Swasa (Dyspnoea with pain)
877
SICKLE CELL ANAEMIA
CASE REPORT FORM III – CLINICAL & PHYSIOLOGICAL ASSESSMENT
(Monthly during treatment period and follow up)
1. Centre: ………………..……….
3. Sr. No. of the Subject: ……………………………........…………………………………
Clinical Symptoms Absent Present
7. Relief in fever
8. Weakness
9. Abdominal discomfort
10. Pain in extremities
11. Pain in hip and shoulder joints
12. Any other joint pains
13. Other complaints, if any (Specify)_____________________________________________
If yes, Present specify _____________________________________________________
15. Frequency of crisis
16. Adverse reaction: No (0) Yes (1)
If yes, details: ___________________________________________________________
878
Continuing (1)
Drop out (2) Reason: _____________________________
Died (3) Cause: _______________________________
19. Systolic blood pressure (mm of Hg) __________________________________________
20. Diastolic blood pressure (mm of Hg) _________________________________________
21. Weight (kg) _____________________________________________________________
Date: ____________ Signature of the Investigator:________________
879
SICKLE CELL ANAEMIA
(Monthly during treatment and monthly during follow up)
(To be done before, at the end of three months and end of the treatment)
1. Centre: ………………..……….
3. Sr. No. of the Subject: ……………………………........…………………………………
8. TC (Cells/Cmm.) __________________________
9. DC: P (%)_______ L (%)_______ E (%)_______ M (%)_______ B (%)_______
10. Hb(g/dl) _________.
11. PCV (%) ___________
12. ESR (1st hour) (mm) _____________________
13. BT
14. CT
15. Platelet count
16. Reticulocyte count
880
17. Peripheral smear for sickling (before treatment only)
18. Serum Iron (Microgram per dl.)
19. Serum Ferritin (Nanogram/ml.)
20. Sickling test (before and end of the treatment only)
21. Haemoglobin Electrophoresis (before treatment only)
22. Serum Hb. F level (0 and 6 months)
Serum Hb. S level (0 and 6 months)
23. B. Urea (mg./dl) ________________
24. S. Creatinine (mg./dl) ________________
25. S. Bilirubin
26. SGPT
27. SGOT
28. S. Alkaline phosphates
29. S. Proteins
881
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882
IMMUNE SYSTEM
SECTION - XV
Blank
884
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN
HIV INFECTED PERSONS AS AN SUPPORTIVE
THERAPY
Drug: Study Code:

AND SIDDHA
885
Blank
886
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
I. BACKGROUND
Acquired immunodeficiency Syndrome1 or AIDS is a disease of the defense system of the
body. The causative organism is Human Immunodeficiency Virus (HIV), which belongs to the
family of human retroviruses. This virus attacks the immune system of the human beings, leading
to depletion of CD4 cells resulting in immunodeficiency. Because of immunodeficiency the person
becomes susceptible to various secondary infections and neoplasm that are AIDS-definiting illness.
The World Health Organisation estimates that there are over 1.75 millions HIV infected
adults throughout India. In majority of cases infection occur through sexual route and rest through
blood transfusion, injecting drugs etc.
There are four broad approaches to the treatment of HIV infection. These include 1.
Treatment or prophylaxis of specific opportunistic infections 2. General management 3. Anti
retroviral agents, which include reverse transcriptase (RT) inhibitors and proteinase inhibitors 4.
Immunorestorative therapy.
Presently Zidovadine (AZT), Didanosine, Zalcitabine and Lamivudine are available RT-
inhibitors; Saquinavir, Kitovavir and Indinovir are the available proteinase inhibitors.
However, the major limitations of these drugs to be used in our country include 1.
Restricted availability in our country. 2. Major side effect 3. High cost 4. Unequivocal findings in
their role in preventing progression to AIDS related complex (ARC) or AIDS.
WHO had noticed inability of people in developing countries to purchase costly medicines
used in the treatment of AIDS. Hence it is trying to promote indigenous drugs available in these
countries, through scientific study.
Since the initial recognisition of the clinical manifestations of HIV-1 infection are the result
of declining cellular and humoral immune responsiveness, there have been a number of efforts to
reverse this decline through the use of a) agents with putative general immune enhancing activity
and b) recombinant cytokines. However, these are complicate both by uncertainty of mechanism
in terms of agents with putative general immune enhancing activity and by the complex immune
regulatory milieu in which either general immune modulators or cytokines are used.
Immune based therapeutic intervention for HIV-1 infection may be divided into two broad
categories. These include reconstitution of general immune responsiveness and augmenting HIV-
1 specific immune responses.
1. Harrison’s Principle of Internal medicine: 15th Edition
887
The development of highly active antiretroviral drugs, especially protease inhibitors, has
resulted in the identification of potent combination regimens that clearly serve as the main stay of
current therapy for HIV infection. However, despite the profound suppression of viral replication
that can be seen with these combination therapies, the level of immune restoration associated with
such therapies appear to be limited in many patients. Furthermore, the duration of viral suppression
in many patients is also limited, especially for those with long exposure histories to many of the
available antiretroviral drugs, which were often utilized sequentially as single agents. Thus
identification of effective alternative therapeutic approaches for the treatment of HIV-infected
patients is essential.
Some studies showed that Ayurvedic preparations were effective only if used as
prophylactic and not if used as curative. They produce most of their effects by primarily acting on
the immune system. It had been shown that Ayurvedic preparations, given to rats whose
macrophages have been overloaded with a fat lipofyundin, were unable to stimulate macrophages
and thus proving that stress induced damage is no preventable.
Ayurvedic preparations act primarily by activating the macrophages. It increases the
phagocytic activity of macrophages and also induces expression of MHC-II antigens indicating
enhancement of their antigen-presenting ability. In vitro, treatment of mice splenocytes with
Ayurvedic preparations stimulated the production of II-2, IFN-Gamma and TNF-Alpha reflecting
activation of Th-1 type of T cell responses. Since Th-1 type of response has been implicated with
the cell mediated immunity the therapeutic effect of Ayurvedic preparation, as reported may be
mediated by activation of cellular immune responses. In fact, the antimicrobial properties of
Ayurvedic preparation have found to be mediated by the immune system.
In the Indian scenario, Ayurveda could possibly contribute in this respect by using rasayana
and balya oushadi dravyas. The development of immune-potentiators with Ayurvedic drugs has
opened an entirely new chapter in therapeutics.
In AIDS the patient losses something essential. The cellular immunity becomes defenseless
against the pathogens and suffers from various clinical manifestations. These manifestations are
similar to that of OJOKSHAYA2-3 or BALAKSHAYA patients, depicted in Ayurvedic classics.
By administrating the rasayana medicaments meant for ojovardhaka, balavardhaka which will
promote the process of dhatu poshana and enrich ojus and thus leads to improve the vital
strength and immunity or vyadhi kshamatva (non-specific immunity).
2. Charaka Samhita, Sutra Sthana Chapter – 17/73, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
3. Ambika Dutta Sashtri (1989) Susruta Samhita (text with Hindi commentary), Sutra Sthana, Chapter
15/24, VIIth, Edition Chaukhamba Sanskrit Series Office, Varanasi.
888
If AIDS is treated in this way, it may lead to break through for newer views in solving the
problem.
Hence the present study is designed to evaluate efficiency of certain selected Ayurvedic
formulations in HIV/AIDS patients as a supportive therapy for improving quality of life. The
selected drug will be evaluated for its rasayana and balya properties.
II. OBJECTIVE
The study is aimed to evaluate the efficacy of the Ayush-QOL-2 in HIV infected persons,
as a supportive therapy for the improvement of quality of life.
III. CENTRES

Sample size : 100 subjects (divided in to two equal groups) per centre
Group I : Available standard management + Ayush – QOL –2 (considered as trail
group) – 50 subjects
Group-II : Available standard management for HIV/AIDS patients+ Placebo
(placebo/control drug will be made similar to trial drug) - 50 subjects
Dose of the trial drug : 2 tablets (500 mg/tab) tid
Type of study : Double blind randomized controlled trial.
Level of study : OPD level only.
Period of study : Six months.
Follow-up :
A. During study, patients will be screened for HIV/AIDS depending upon the investigations
report and other clinical signs and symptoms. ELISA will be used for screening and western blot
test for confirming of HIV infections. Patients will be followed for a period of six months and
were carried out investigations CD4+, Beta-2 micro globulin level, Viral load and gm% of
Haemoglobin with interval of two months.
B. In addition to laboratory findings, change in body weight, reduction in opportunistic
infections, improvement in Karnofsky performance score and improvement in clinical status of the
patient will be reviewed periodically.
889
V. CRITERIA FOR INCLUSION:
1. Age group – 20 to 60 irrespective of sex
2. Seropositive to HIV-1 or HIV-2 or both
3. Western Blot positive
4. CD4 count ranging from 200-500/cu. mm
5. Hb gm% at least 7 gm%
6. Patients with normal hepatic and renal function
7. Patients with total lymphocyte count 2000/cu.mm and platelet counts 75000/cu.mm
8. Able to understand and give written consent
VI. CRITERIA FOR EXCLUSION:

1. Pregnant or lactating females.
2. Presence of serious systemic illness – e.g. Chronic renal failure, hepatic failure,
cardiovascular diseases, endocrinal or metabolic disorders (such as diabetes
mellitus).
3. History suggestive of pulmonary tuberculosis, pneumocystis, carinii pneumonia,
toxoplasmosis.
4. Patients suffering from secondary infections or opportunistic infections like severe
chronic diarrhoea, all types of pneumonias, disseminated diseases, brain abcesses,
meningitis, encephalitis, herpes simplex, herpes zoster, syphilis, toxoplasmosis,
cytomegalovirus infection.
5. Patients with neoplasms – visceral kaposi’s, lymphomas, invasive cervical
carcinoma.
6. Other conditions like peripheral neuropathies, pancreatitis, G6PD deficiency, HIV
wasting syndrome etc. that may potentially interfere with the study.
7. Past history of drug allergies.

A patient may be withdrawn from the study in case of any one of the following
• Development/occurrence of a life threatening illness.
890
• Severe adverse effect of the drug.
VIII. ROUTINE EXAMINATION AND ASSESSMENT:

The efficacy of the trial drug will be assessed on the basis of changes in clinical parameters
as well as laboratory investigations.
A. Clinical parameters:
i. Weight gain
ii. Improvement of Karnofsky performance score
iii. Reduction in opportunistic infections
iv. Improvement in clinical status of the patient (subjective scales of measurement of
symptomatic improvement 0=Static; 1=Mildly better; 2=Moderately better;
3=Much better)
B. Laboratory investigations:
i. Increase in CD4 count
ii. Decrease in Beta-2 micro globulin level
iii. Decrease in viral load
iv. Increase in Hb%
IX. GENERAL MANAGEMENT:

Patients will be managed on OPD level only at HIV/AIDS clinic, J.J. Hospital, Mumbai.
Physicians on the set proforma will make periodic assessments.
Patients will be instructed to avoid other forms of medicines during the period of trial.
They should report to the physicians immediately for appropriate treatment in the event of
development of other diseases.
Strict confidentiality of all data collected will be maintained to prevent embarrassment of
victimization of patients. Consent form will be obtained from every patient.
Before treatment and after treatment data on clinical and laboratory parameters taken into
account for diagnosis and for the assessment of results of treatment will be tabulated and analysed
891
using suitable statistical method.

The monitoring of progress of the trial and data analysis will be undertaken by CCRAS.
XII. ETHICAL REVIEW

Each Institutional Ethical Committee (IEC) of participating Centre’s should give clearance
892
APPENDIX
KARNOFSKY PERFORMANCE SCORE REFERENCE SHEET
Able to carry on normal activity; No special care is needed

100 Normal; No complications; No evidence of disease.
90 Able to carry on normal activity.
80 Normal activity with effort; Some signs (or) symptoms of disease.
Unable to work; Able to live at home; Care for most personal needs; A varying amount of
assistance is needed
70 Cares for self; Unable to carry on normal activity (or) to do active work.
60 Requires occasional assistance and frequent medical care
50 Requires considerable assistance and frequent medical care.
Unable to care for self; requires equivalent of institutional or hospital care; Disease may be
progressing rapidly
40 Disabled; Requires special care and assistance.
30 Severely disabled, hospitalization is indicated, though death is not imminent.
20 Very sick; Hospitalization is necessary; Active supportive treatment is necessary.
10 Moribund; Fatal processes are progressing rapidly.
0 Dead
893
the patient.
Date:___________ Signature _________________________

Name ____________________________
CONSENT BY SUBJECT
this study.
I, exercising my free power of choice, hereby give my consent to be included as
a subject in the clinical trial on “Evaluation of Efficacy of Ayush QOL-2 in HIV Infected
Persons as an Supportive Therapy”
Date: ________________ Signature or Thumb impression_________

Name of subject____________________
Date: ________________ Name of witness: ___________________

Signature or Thumb impression: ________
Relationship: _______________________
894

Acquired immunodeficiency Syndrome or AIDS is a disease of the defense system of the
body. The causative organism is human immunodeficiency virus (HIV), which belongs to the
family of human retroviruses. This virus attacks the immune system of the human beings, leading
to depletion of CD4 cells resulting in immunodeficiency. Because of immunodeficiency the person
becomes susceptible to various secondary infections and neoplasm that are AIDS-definiting illness.
The World Health Organisation estimates that there are over 1.75 millions HIV infected
adults throughout India. In majority of cases infection occur through sexual route and rest through
blood transfusion, injecting drugs etc.
There are four broad approaches to the treatment of HIV infection. These include 1.
Treatment or prophylaxis of specific opportunistic infections 2 General management 3. Anti
retroviral agents, which include reverse transcriptase (RT) inhibitors and proteinase inhibitors 4.
Immunorestorative therapy.
Presently Zidovadine (AZT), Didanosine, Zalcitabine and Lamivudine are available RT-
inhibitors; Saquinavir, Kitovavir and Indinovir are the available proteinase inhibitors.
However, the major limitations of these drugs to be used in our country include 1.
Restricted availability in our country. 2. Major side effect 3. High cost 4. Unequivocal findings in
their role in preventing progression to AIDS related complex (ARC) or AIDS.
WHO had noticed inability of people in developing countries to purchase costly medicines
used in the treatment of AIDS. Hence it is trying to promote indigenous drugs available in these
countries, through scientific study.
Since the initial reorganization of the clinical manifestations of HIV-1 infection are the result
of declining cellular and humoral immune responsiveness, there have been a number of efforts to
reverse this decline through the use of a) agents with putative general immune enhancing activity
and b) recombinant cytokines. However, these are complicating both by uncertainty of mechanism
in terms of agents with putative general immune enhancing activity and by the complex immune
regulatory milieu in which either general immune modulators or cytokines are used.
Immune based therapeutic intervention for HIV-1 infection may be divided into two broad
895
categories. These include reconstitution of general immune responsiveness and augmenting HIV-
1 specific immune responses.
The development of highly active antiretroviral drugs, especially protease inhibitors, has
resulted in the identification of potent combination regimens that clearly serve as the main stay of
current therapy for HIV infection. However, despite the profound suppression of viral replication
that can be seen with these combination therapies, the level of immune restoration associated with
such therapies appear to be limited in many patients. Furthermore, the duration of viral suppression
in many patients is also limited, especially for those with long exposure histories to many of the
available antiretroviral drugs, which were often utilized sequentially as single agents. Thus
identification of effective alternative therapeutic approaches for the treatment of HIV-infected
patients is essential.
Some studies showed that Ayurvedic preparations were effective only if used as
prophylactic and not if used as curative. They produce most of their effects by primarily acting on
the immune system. It had been shown that Ayurvedic preparations, given to rats whose
macrophages have been overloaded with a fat lipofyundin, were unable to stimulate macrophages
and thus proving that stress induced damage is no preventable.
Ayurvedic preparations act primarily by activating the macrophages. It increases the
phagocytic activity of macrophages and also induces expression of MHC-II antigens indicating
enhancement of their antigen-presenting ability. In vitro, treatment of mice splenocytes with
Ayurvedic preparations stimulated the production of II-2, IFN-Gamma and TNF-Alpha reflecting
activation of Th-1 type of T cell responses. Since Th-1 type of response has been implicated with
the cell mediated immunity the therapeutic effect of Ayurvedic preparation, as reported may be
mediated by activation of cellular immune responses. In fact, the antimicrobial properties of
Ayurvedic preparation have found to be mediated by the immune system.
In the Indian scenario, Ayurveda could possibly contribute in this respect by using rasayana
and balya oushadi dravyas. The development of immune-potentiators with Ayurvedic drugs has
opened an entirely new chapter in therapeutics.
In AIDS the patient losses something essential. The cellular immunity becomes defenseless
against the pathogens and suffers from various clinical manifestations. These manifestations are
similar to that of OJOKSHAYA - or BALAKSHAYA patients, depicted in Ayurvedic classics.
By administrating the rasayana medicaments meant for ojovardhaka, balavardhaka which will
promote the process of dhatu poshana and enrich ojus and thus leads to improve the vital
strength and immunity or vyadhi kshamatva (non-specific immunity). If AIDS is treated in this
way, it may lead to break through for newer views in solving the problem.
896
you are expected to visit the hospital in 30 days interval for clinical and physiological assessment.
Principal Investigator.
897
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV/AIDS PATIENTS
CASE REPORT FORM -I SCREENING
2. Centre _______________________________________
3. Name of the patient_______________________________________________________

5. Date of Birth: Age (in yrs.)
6. Address: ______________________________________________________________
CRITERIA FOR INCLUSION

Yes (1) No (0)
1. Age group – 20 to 60 irrespective
2. Seropositive to HIV-1 or HIV-2 or both
3. Western Blot positive
4. CD4 count ranging from 200-500/cu.mm
5. Hb gm% at least 7 gm%
6. Patients with normal hepatic and renal function
7. Patients with total lymphocyte count 2000/cu.mm
8. Platelet counts 75000/cu.mm
CRITERIA FOR EXCLUSION
Yes (1) No (0)

9. Pregnant or lactating females
10. Presence of serious systemic illness
11. History suggestive of pulmonary tuberculosis,
898
pneumocystis, carinii pneumonia, toxoplasmosis.
12. Patients suffering from secondary infections or
opportunistic infections
13. Patients with neoplasms
14. Peripheral neuropathies, pancreatitis, G6PD

deficiency, HIV wasting syndrome etc.
15. Past history of drug allergies.

If admitted:
Sr. No. of the Subject: _______________
Group: Control Trial
No. of packets issued:
Date: ______________ Signature of the Investigator_______________
899
CASE REPORT FORM-II HISTORY
2. Centre __________________________________
3. Sl. No. of the subject: ___________________________________________________

6. Address: _______________________________________________________________
7. Educational Status
Illiterate 1 Read and Write 2 Primary School 3
Indicate nature of work: . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . .
9. Income per capita per month in Rs
11. Marital Status: Married 1 Unmarried 2 Widow 3

In case of (3), (4) or (5) since when ________________________________________
12. Sexual History Heterosexual 1 Homosexual 2
Bisexual 3 Multi partner 4
Abstentation 5
900
If yes
13. History of exposure towards No Yes No. of Month/year Place
medical causes (0) (1) times Latest episode
1. Blood transfusion
2. Blood products
3. Major surgery
4. I.V drug use
5. Needle pricks/Needle stick injury
6. Other relevant causes
14. History of present illness: _____________________________________________

_____________________________________________
_____________________________________________
15. History of past illness: _____________________________________________
_____________________________________________
_____________________________________________
16. Family History _____________________________________________
_____________________________________________
_____________________________________________
17. Personal History
No (0) Yes (1)
1. Active drug abuse
2. Consumption of alcohol
3. Smoking habit
901
18. Examination of the Patient
A. General Examination No (0) Yes (1) If yes, duration
(in months)
1. Fatigue
2. Fever
3. Night sweats
4. Anorexia
5. Weight loss
6. Diarrhoea
7. Cough
8. Breathlessness
9. Headache
10.Vomiting
11.Oedema
12.Dermatitis
13.Herpes
14.Any others
B. Systemic Examination Normal Abnormal

If abnormal, give the details: _________________________________________
3. Gastro-Intestinal system
902
5. Genito-Urinary system
If abnormal, give the details: __________________________________________
C. Vital Signs: Present Absent
1. Pallor
2. Icterus
3. Cyanosis
Central/Peripheral)
4. Clubbing
5. Koilonychia
6. Oedema
a. Legs
b. Face
c. General
7. Lymphadenopathy
If present, size (cm)____________________

Site: Cervical____________ Axillary____________ Inguinal_______________
8. Temperature (0F):_________________
9. Pulse (rate/min.):_________________
10. Blood Pressure (Systolic/Diastolic) in mm of Hg: ____________________________
D. Anthropometry:
1. Height (in cm): _______________
2. Weight (in Kg): _______________
903
3. Chest circumference (in cm): _______________
4. Abdominal circumference (in cm): _______________
5. Mid arm circumference (in cm): _______________
6. Thigh circumference (in cm): _______________
19. Past Drug Schedule
S.No. Name of medication Period of Prescribed by Total daily Duration

treatment (in days)
From To Dose Unit
1.
2.
3.
4.
5.
6.
7.
8.
20. Past Adverse Drug Effects
S.No. Name of Drug Details of Adverse Effects Definite/Possible

1.
2.
3.
4.
5.
6.
7.
8.
Date: ____________ Signature of the Investigator: ____________________
904
CASE REPORT FORM-III LABORATORY INVESTIGATIONS
(All investigations to be carried out during pre-entry screening level. During treatment CD4
count, Beta-2 micro globulin level, Viral load and gm% of haemoglobin will be done at every
two months interval)
General Information
2. Centre _____________________
3. Sl. No. of the subject:
6. Date of Birth: Age (in yrs):
7. Date of starting treatment:
8. Date of assessment: Month No:
Blood Tests
Negative (0) Positive (1)
9. HIV Antibodies by ELISA test
10. Western Blot test
11. Beta-2 micro globulin:____________________________________________________

12. PCR (Infectious particles/ml.):______________________________________________
Cell Count Normal range

13. Haemoglobin : ________________ 12-16 gm/dl
14. RBC counts : ________________ 4-6 x 103/¼L
15. PCV : ________________ 37-52%
905
16. ESR (1 hour) : ________________ 10-20 mm
17. Leucocyte count : ________________ 4,000-10,000/¼L
18. Neutrophil count : ________________ 40-60%
Lymphocyte Count
19. Total T-Lymphocyte count : ________________ 60-88%
20. Total CD4 count : ________________ 32-66%
21. Total CD8 count : ________________ 10-43%
22. CD4 : CD8 ratio : ________________ 1
23. Platelet count : ________________ 150,000-400,000/¼L
Blood Chemistry
24. VDRL Negtive (0) Positive(1) (titre:____________)
25. HBV testing Negtive (0) Positive(1) (titre:____________)
26. Blood sugar (mg%) : ________________ 60-100 mg/100 ml
27. Blood urea (mg%) : ________________ 14-38 mg/ 100 ml
28. Serum Creatinine (mg%) : ________________ 0.5-1.8 mg/100 ml
29. Serum Uric acid (mg%) : ________________ 2.0-6.0 mg/100 ml
30. Serum Bilirubin (mg%) : ________________ 0.1-0.8 mg/100 ml
31. SGOT (IU) : ________________ 0.20 IU/ml
32. SGPT (IU) : ________________ 0.15 IU/ml
Proteins (gm%)
33. Total protein : ________________ 6-18 gm/dl
34. Albumin : ________________ 3.5-5.5 gm/dl
35. Globulin : ________________ 2.0-3.6 gm/dl
36. Prothrombin time (sec.) : Normal 11-14_________(Control)________(Patient)
906
Skin Sensitivity Test (With 5 units)
37. Mantoux test (mm) : ________________ Normal 10 mm
38. Urine
Routine _______________________________________________________________
Microscopic___________________________________________________________
39. Stool Examination
Routine ________________________________________________________________
Microscopic___________________________________________________________
40. Chest X-ray : _________________________________________________________
41. ECG : _________________________________________________________
Final Diagnosis
42. CDC STAGE: Stage II (2) Stage III (3)
Stage IV (4)
43. Sr.No. ________________________________________________________________
44. Group: Control Trial
Date:________________ Signature of Investigator: _______________________
907
CASE REPORT FORM-IV ASSESSMENT
2. Centre _____________________
3. Sl. No. of the subject:
4. Name of the patient______________________________________________________
6. Date of Birth: Age (in yrs):
7. Clinical Parameters
Clinical (Parameters) Before the trial Follow-up period (in months)
i. Weight 0 1 2 3 4 5 6
ii. Karnofsky (Performance) score
iii. Incidences of opportunistic infections
iv. Clinical status of the patient
1. Fatigue
2. Fever
3. Night sweats
4. Anorexia
5. Diarrhoea
6. Cough
7. Breathlessness
8. Headache
9. Vomitting
10. Oedema
908
11. Dermatitis
12. Herpes
13. Any others
8. Laboratory Parameters
Laboratory Parameters Before the trial Follow-up period (in months)
0 2 4 6
v. CD4 Count
vi. Bet-2 micro globulin level
vii. Viral load
viii. Haemoglobin (gm%)
9. Sr.No. of the subject: _________________________
10. Group Control Trial
11. Was the patient withdrawn from the trial? No (0) Yes (1)
If yes, principal investigator to record all details below)

12. Remarks, if any: ___________________________________________________
___________________________________________________
___________________________________________________
Date: _____________ Signature of the Investigator: ____________________
909
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910
DISORDERS OF SKIN
SECTION - XVI
Blank
912
EVALUATION OF THE THERAPEUTIC EFFECT OF
SINGLE DRUGS/COMPOUND AYURVEDIC
FORMULATIONS AND SHODHANA THERAPY IN THE
MANAGEMENT OF KITIBHA (PSORIASIS)
Drug: Study Code:

AND SIDDHA
913
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914
AND SIDDHA
EVALUATION OF THE THERAPEUTIC EFFECT OF SINGLE DRUGS/
COMPOUND AYURVEDIC FORMULATIONS AND SHODHANA THERAPY IN
THE MANAGEMENT OF KITIBHA (PSORIASIS)
I. BACKGROUND:
Psoriasis1 is a common chronic non-infectious skin disease said to be idiopathic, according
to modern medicine. In Ayurveda the causative factors of skin disease are elaborately classified.
Continued practice of Apathya Aharavihara and Manovriti, the doshas and dhatus are vitiated and
cause Kitibha. In Kitibha vatakapha doshas are predominantly involved and this disease is
included under the category of ‘Kshudra Kushtha’. Kitibha is roughly compared and accepted
with Psoriasis of Modern Medical diagnosis. Cases characterized with well defined erythematus
plaques with large adherent silvery scale with exfoliation are taken up for study.
The preliminary clinical trials with Kaisoraguggulu, Arogyavardhini and Nimbidin were
conducted earlier with different external applications groups of Samana therapy and one groups of
Shodhana therapy along with rasayana treatment is taken up for clinical evaluation. This study is
conducted in O.P.D and I.P.D. levels.
AYURVEDIC LITERATURE
Earlier studies in Kitibha confirmed that, this disease can be equated with Psoriasis
especially with stable plaque Proriasis. The signs and symptoms of Kitibha shown below are
almost identical with Psoriasis.
1. Ruksha - Dryness of the skin
2. Kinakharasparsa - Hard an torturous skin
3. Kandu - Itching
4. Parushya - Roughness
5. Asita - Hyperpigmentation
1 References: Charaka Samhita, Chikitsa Sthana Chapter– 7, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
915
As per Ayurvedic concept, Kitibha is classified under Kshudra Kushtha. The line of
treatment for Kitibha is based in the general treatment of kushtharoga. The main treatment is
sodhana followed by Samana and Rasayana therapy. Many single and compound herbal and
herbomineral preparations are mentioned in Ayurvedic classics and text books. Plant origin drugs
like Nimba, Bhallataka, Aragwadha, Madhusnuhi, Khadira, Majishta, Haridra, Guduchi, Bakuchi,
Chakramarda, Guggulu, Karanja etc. mineral origin drugs like Rasa, Gandhaka etc and animal
origins like Gomutra, Ghee etc. are some of the drugs used alone and as ingredients in many
important compound preparations in various Kushtarogas.
Although there are many single and compound medicines prescribed for the treatment of
Kushtharogas there is no special scientific study carried out in single or compound drugs to
evaluate their therapeutic effect in a particular disease like Kitibha. So here are a few group of
drugs are giving to evaluate their therapeutic effect in Kitibha.
MODERN CONCEPT
In Psoriasis, main abnormality is of increased epidermal proliferation due to excessive
multiplication of cells in the basal layers. The transit time of keratinosite shortened and epidermal
turn over is reduced from 28 to 34 days. Even though the etiology is unknown, the factors
involved are genetic, biochemical, immunopathological and dermal. These factors may not be fully
sufficient to develop Psoriasis, precipitating factors like trauma, infections, sunlight some drugs and
emotions may cause flare up of the disease. There are different types of Psoriasis like Stable
Plaque Psoriasis, Guttate Psoriasis, Erythrodermic Psoriasis, Pustular Psoriasis. Of these, Stable
plaque Psoriasis is dry silvery white scales. The elbow, knee, lower back are commonly involved
areas, other sites include are scalp, nails, flexures, palm and napkin area.
Guttate Psoriasis is common in children and adolescents. The rashes often appear rapidly
and lesions are small, scaly and drop-let shape. Usually the lesions plaque disappears in a few
months, but later it may develop into plaque pattern. Erythrodermic lesions are red and scaly.
Shivering is also severe in this group due to considerable heat loss. In Pustular Psoriasis, sudden
onset with myriads of small sterile pustule erupting on an erythematous base. This type is
generalized from which is rare but serious type and it requires hospitalization. Localized form is
more common and involve mostly in palm and soles. The eruption consists of numerous small
sterile pustule lying on an erythematous base.Psoriatic arthropathy involves terminal interphalangeal
of toes and fingers and larger joints like sacroiliac joints and lumbarspine.Coaltar preparations,
calcipotriol, retinoides, corticosteroids an ultraviolet radiation are the local measures to manage
Psoriasis. The systemic treatment commonly used are photo chemotherapy with PUVA, retinoides,
mothotrexate and cyclosporine-A under regular specialist supervision. Systemic treatment is given
only when the local measures fail to respond.
916
II. OBJECTIVES
To evaluate the therapeutic effect of single drugs/compound Ayurvedic formulations and
Shodhana therapy in the management of Kitibha (Psoriasis).
III. SAMPLE SIZE AND METHOD

The patients between the age group of 15 to 70 years in either sex presenting the clinical
symptoms of the disease mentioned in the clinical protocol will be taken for trial. After taking
detailed clinical history careful physical examination supported with positive laboratory findings, the
patients will be put under trial either by admitting in the I.P.D. or as an outpatient. Patients
suffering from sub-acute stage of Psoriasis during that particular period with not less than 30%
involvement of the body surface alone will be taken for trial. Patients having less than 10 years
duration will be taken for the study. Patients who can report in person every week in the out
patient department will be included for clinical trial.
Number of patients in each group: 50 patients
Groups: three different groups
Type of Study: Single Blind
Level of Study: O.P.D. and I.P.D. level
Period of Study: 3 months (90 days), 15 days interval.
Follow Up: After completion of the trial, patients are advised to report in the O.P.D. of the
Institute once in every month continuously for twelve months.
DOSE SCHEDULE
Group 1:
- Arogyavardhini 500 mg along with Kaisoraguggulu 1 mg thrice daily for 3 months.
- Chakramarda Keratailam for external application
Group 2:
- Panchanimba lauha churna 2 gms, Kamadudha rasa 250 mg and haridrakhanda 3 gm
(mix together in a single dose) twice daily.
Group 3:
- Snehapana for 7 days with Mahatiktaka Ghrita, Mrudu Swedana for one day.
917
- and Samsarjana
- Then after Rasayanaprayoga with Bhallataka for 3 months.
IV. INCLUSION CRITERIA
- Shodhana
V. EXCLUSION CRITERIA
Age below 15 years and above 60 years, patients suffering from any severe systemic
disease like Diabetes, Renal disease, H/O Liver disease, in the recent past VDRL positive cases
will be excluded form the trial.
Patients with other forms of Psoriasis like Guttate, Pustular, Erythrodermic, Psoriatic
arthropathy and patients addicted to alcohol will not be included in the trial.
VI. CRITERIA FOR WITHDRAWL

1. Personal matters
2. Inter current illness
3. Aggravation of complaints
4. Any other
VII. CRITERIA FOR EXAMINATION AND ASSESSMENT

The diagnosis will be made on the basis of the following clinical findings.
1. Typical distribution of the Psoriatic lesions on the surface of the body such as elbow,
knee, lower back, scalp, nails etc.
2. Well defined non-indurated, dry erythematous area with silvery layer scaling.
3. The candle grease sign, kobener’s phenomenon and the pin point bleeding on removal
of scale.
4. Little or no itching.
5. History or previous attack or seasonal relapse.
6. Positive Histo-pathological findings.
7. Assessment of cases will be carried out weekly.
918
VIII. CRITERIA FOR ASSESSMENT OF RESULTS
Result of the treatment will be graded as follows:
1. Complete relief:
(a) 100% relief of sign and symptoms of the disease indicated under the head of
diagnosis.
(b) Complete disappearance of the disease as evident in the colour photographic
assessment.
(c) Favorable alterations in the laboratory investigations.
(d) Considerable improvement in the general well being of the patient (Both subjective
an objective).
2. Marked relief:
(a) 76% to 99% relief. Improvement of the presenting clinical symptoms of the disease
recorded earlier.
(b) Significant change in the skin lesions observed in the photographic assessment.
(c) Satisfactory change in the laboratory investigations.
(d) Overall improvement in the well being of the patients.
3. Moderate relief:
(a) 51% to 75% relief in signs and symptoms recorded earlier.
(b) Satisfactory change in the skin lesions observed in the photographic assessments.
(c) No change in the laboratory investigations
(d) Satisfactory improvement in the general well being of the patient.
4. Mild relief:
(a) 10% to 50% improvement in the clinical symptoms of the disease.
(b) No change in laboratory findings.
(c) Mild improvement in the well being of the patient.
5. No relief:
(a) No relief or below 10% improvement
(b) No change in laboratory findings
(c) No change in photographic assessment
919
(d) No improvement in the well doing of the patient.

tabulated and analyzed using appropriate statistical tools.

The progress of the trial will be monitored by CCRAS Hqrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS Hqrs. New Delhi
XI. ETHICAL REVIEW

Each Institutional Ethical Committee (IEC) of participating centres should give clearance

A consolidated amount of Rs.……. /- per visit after screening and at the end of
every further visit.


Blood: TLC, DLC, Hb%, ESR, Blood Sugar, Serum Cholesterol, VDRL
Urine: Albumin, Sugar, Bile Salt and routine investigations.
Stool: Ova, Cyst.
These investigations will be repeated every fifteen days.
920
the patient.
Date: ___________ Signature _________________________

Name ___________________________
CONSENT BY SUBJECT
this study.
I, exercising my free power of choice, hereby give my consent to be included as a
subject in the clinical trial on “Evaluation of the therapeutic effect of single drugs/compound
Ayurvedic formulations and Shodhana therapy in the management of Kitibha (Psoriasis).”
Date: ________________ Name of subject__________________________

Signature or Thumb impression_______________
Date: ________________ Name of witness: _________________________

921
EVALUATION OF THE THERAPEUTIC EFFECT OF SINGLE DRUGS/
COMPOUND AYURVEDIC FORMULATIONS AND SHODHANA THERAPY IN
THE MANAGEMENT OF KITIBHA (PSORIASIS)

Psoriasis is a chronic recurrent intractable disease with world wide distribution. It
constitutes almost 10% of all skin diseases. Although Psoriasis is not a life threatening disease, it
is associated with disfigurement, restrictions of activities and complications like arthritis. As far as
curative aspect of the treatment of the disease is concerned, ever after the discoveries of certain
advanced medicines, there is no effective treatment except symptomatic relief temporarily in
modern medicine.

you are expected to visit the hospital in 15 days interval for clinical and physiological assessment.
Principal Investigator.
922
EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL COMPOUND
DRUGS
CASE REPORT FORM I- SCREENING
1. Name of the patient: ..............................................Age: ................ Sex: .......................
2. Address: .................................................................................................................................
3. Centre: ..................................................................
5. Patient No.
6. Group No. Group 1 Group 2
1. Age between (15 – 70 yrs)
2. Kandu
3. Ruksha
4. Parushya
5 Rekamandala
6. Twakvigalana
7. Nuna Twakvivarnya
8. Ati Twakvaivarnya
9. Acute Guttate
10. Flexular
11. Pustular
923
CLINICAL EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL
COMPOUND DRUGS
1. Name of the patient: .................................................... Age: ................... Sex: ..................

2. Address: .................................................................................................................................
3. Date of admission: Date of Discharge:
4. Center: .................................................................................................................................
6. Patient No:
7. Group No: 1 2 3
Illiterate 1 Read and Write 2 Primary School 3
9. Occupation:
Indicate nature of work: ...........................................................................................
Total income of the family (in Rs.): ...........................................................................
11. Income per capita per month (in Rs.):
924
Christian 4 Parsi 5
13. Marital Status: Married 1 Unmarried 2 Widow 3
14. Result: Good Response 1 Fair Response 2 Poor Response 3
No Response 4 Drop out 5 Lama 6
Death 7
CHIEF COMPLAINTS WITH DURATION
Present Absent Duration (in days)
15. Itching:
16. Dryness of the skin:
17. Roughness:
18. Circular erythemia:
19. Exfoliation:
20. Hyper Pigmentation:
21. Hypo-Pigmentation:
22. Maceration:
23. Pin point bleeding

after removal of skin
24. Papule/Pustule/Vesicle
25. Fissures:
26. Onset of disease: Acute Insidious
27. Duration of disease:
28. Treatment given so far: Ayurvedic medicine Modern Medicine
Unani Homeopathy
925
Mixed
29. Factors aggravating the disease/chief complaint:
Drug Diet Cold climate

Occupational
Positive factors may spell out: ................................................................................................
30. History of the significant past illness, Yes No
having relation with present illness.

If Yes, specify: ....................................................................................................................
FAMILY HISTORY Yes No

31. Hypertension
32. Diabetes
33. Mental disease
35. Cancer
36. Tuberculosis
37. Skin disease
38. Others, specify:.....................................................................................................................
PERSONAL HISTORY
39. Diet: Veg Non-veg Lacto ova veg
40. Sleep: Good Distributed Insomnia
41. Emotional Stress: Yes No
42. Bowel Habit: Regular Constipation
Hard Stool Loose Stool
43. Prakriti: Vata Pitta Kapha
926
44. Manasa Prakriti Satva Rajas Tamas
Satva-Rajas Satva-Tamas Sama
45. Addiction: Yes No
If yes, specify: .....................................................................................................................
46. Built: Lean Medium Heavy
47. Gait: Normal Abnormal
49. Blood Pressure (Systolic):
50. Blood Pressure (Diastolic):
51. Body Temperature:
52. Pulse:
53. Respiration:
Present Absent
54. Cyanosis:
55. Anaemia:
56. Jaundice:
57. Pigmentation:
58. Clubbing of fingers:
59. Deformation:
60. Lymphadenopathy:
927
SYSTEMATIC EXAMINATION
Normal Abnormal
61. C.V.S. with chest:
If abnormal, specify abnormalities: .....................................................................................

62. C.N.S.
63. Digestive System:
If abnormal, specify abnormalities:.....................................................................................
64. Respiratory System:
65. Uro-Genital System:
Samprapti (Pathogenesis) of the disease according to Ayurvedic Concept

Vata Pitta Kapha
66. Anubandha:
67. Anubandhya dosha:
68. Avaraka dosha:
69. Ksheena dosha:
70. Ksheena dhatu: Rasa Rakta Mamsa
Meda Asthi Majja
Shukra Oja
71. Dushya involved: Rasa Rakta Mamsa Meda
Asthi Majja Shukra
Sanchaya Prakopa Prasara
928
Sthana Sanshraya Vyakti Bheda
73. Srota Pariksha
(a). Pranavaha Srotas: Alpa-alpa Swasa (Dyspnoea)
Atisrishta Swasa (Increased respiration rate)
Abhikshna Swasa (Cheyne stroke breathing)
Kupita Swasa (Vitiated)
Sasula Swasa (Dyspnoea with pain)
(b). Udakavaha Srotas: Jihva Shosa Ostha Shosa

(Dryness tongue) (Dryness of lips)
Talu Shosa Kantha Shosa

(Dryness in Palate) (Dryness in throat)
Kloma Shosa Trishana

(Excessive thirst) (Feeling of thirst)
(c). Annavaha Srotas: Ananna Abhilasha Aruchi

(Loss of appetite) (Anorexia)
Avipaka Chardi
(Indigestion) (Vomiting)
(d). Rasavaha Srotas: Mukha Vairasya Arasadyta

(Bad taste in mouth) (Tastelessness)
Hrillas Gaurava
(Water brash) (Feeling of heaviness)
Tandra Avasada
(Drowsiness) (Depression)
Klaibya Karshya
(Loss of libido) (Emaciation)
Agnimandya
(Indigestion)
929
(e). Raktavaha Srotas: Pidaka Rakta pitta
(Boils) (Bleeding from any of the
orifice)
Mukha paka Vidhradhi

(Stomatitis) (Abscess)
Charma roga Kamala

(Skin disease) (Jaundice)
(f). Mamsavaha Srotas: Arbuda Alaji

(Tumor) (Phlyctinolar conjunctivitis)
Gandamala Upjihvika
(Cervical lymphadenitis) (Epiglottis)
Adhimamsa Putimamsa
(Protuberance of flesh) (Decayed flesh/Gangrene)
(g). Medovaha Srotas: Hastapada daha Hastapada Suptada

(Burning sensation in sole (Sensory loss over the
and palm) limbs)
Tandra Dehachikkanata
(Drowsiness) (Greasiness of the skin)
Alasya
(Lethargy)
(h). Asthivaha Srotas: Adhyasthi Adhidanta

(Exostosis) (Redundant teeth)
Dantashoola Asthi shoola
(Toothache) (Tenderness of the bones)
Kesha, Loma, Nakha, Samshru vikara (Any disease of hair, hair follicles, nails and moustaches)
(i). Majjavaha Srotas: Parsava shoola Bhrama

(Pain in the flanks) (Vertigo/Giddiness)
Moorchha Mithya gyana

(Syncope) (Illusion)
930
(j). Shukravaha Srotas: Klaibya Aharshana
(Infertility) (Loss of erection)
Garbhapata Santana vikriti

(Abortion) (Congenital deformity of the
children)
(k). Artavavaha Srotas: Anartava Vandhyatva

(Amenorrhoea) (Sterility)
(l). Mutravaha Srotas Atisrashtamutram, Atibadhamutram,
Prakupita mutra Alpalpa

(Defection urination / Difficulty micturation) (Scantly urination)
Aabhikshna Bahu Mutrata

(Constant/repeated urination) (Excess urination)
Sashoola Mutrata
(Painful micturation)
(m). Pureeshvaha Srotas: Alpalpa Pureesha Sashoola Pureesha

(Scantly defecation) (Painful defecation)
Atidrava Pureesha Atigrathita Pureesha

(Watery motion) (Formation of scybala)
(n). Swedavaha Srotas: Asweda Atisweda

(Anhidrosis) (Hyper Hydrosis)
Parushya Lomaharsha
(Roughness of the skin) (Horripulation)
Anga Paridaha
(Burning sensation in the body)
72. Provisional Diagnosis
73. Final Diagnosis
74. Medical Management
75. Prinicipal drug therapy
Dose :.............................................................................................................................
931
Vehicle :.............................................................................................................................
Diet :.............................................................................................................................
Summary of findings: ..............................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Date: .................................. Signature of Investigator
932
COMPOUND DRUGS
CASE REPORT FORM III – FOR PERIODICAL OBSERVATION &
ASSESSMENT
(Parameters to be taken for assessment of response of therapy)

1. Centre :.............................................................................................................................
2. Code No.:.............................................................................................................................
3. Patient No.: ...........................................................................................................................
4. Group No.:.............................................................................................................................
Initially at the time After 1 2 3 4 5 6 7 8
week week week week week week week week
5. Clinical Parameters Symptoms

i. Itching
ii. Erythema
iii. Thickening
iv. Scaling
v. New Lesion
vi. Any other
vii. Side effects,
If any, specify: ………………………………………………………………………
6. Global Assessment
i. Objective
ii. Subjective
iii. Body Weight
iv. B.P.
933
v. Pulse Rate
7. Clinical Pathological
i. Urine a). Macroscopic
b). Microscopic
Date: ..................................... Signature of Investigator
934
COMPOUND DRUGS
PROFORMA PART IV – RECORD INVESTIGATION

Name of the patient: .....................................................................................................................
1. Center: ......................................................
3. Patient No:
4. Group No: 1 2 3
================================== ======
Investigation At the time After 15 30 days 45 days 60 days 75 days 90 days
of admission days
1 2 3 4 5 6 7 8
Date of sample taken : .....................................................................................................................
5. Urine Sugar
6. Albumin
7. Pus Cell
8. Cast
9. R.B.C.
10. Bile Salt
11. Bile Pigment
12. Stool Ova
13. Occult Blood
14. Sterco Bilin
15. Sputum A.F.B.
935
HEAMATOLOGICAL INVESTIGATION
16. Blood
Hb%
TLC
DLC
(in thousand)
Polymorph
Lymphocyte
Basophil
Monocyte
Eosinophyl
E.S.R.
P.C.V.
Bleeding Time
Prothrombin time
BIOCHEMISTRY INVESTIGATIONS
17. Protein total
18. Albumin Globulin
Ratio
19. Blood Glucose
20. Urea
21. Uric Acid
22. Bilirubin
24. Serum Alkaline
Phosphatase
936
25. Serum Acid
Phosphatase
26. S. G. O. T.
27. S. G. P. T.
28. Triglycerides
29. Total lipid
30. Createnine
Positive Negative
31. Rheumatoid factor
32. V.D.R.L.
33. ASO Titre
RADIOLOGICAL INVESTIGATIONS
Normal Abnormal
34. X-ray
35. Abdomen
36. Spine (AP & Lateral view)
(Specify for region)

37. Kasa Joint (AP & Lateral view)
38. Interphalangeal Joints
(Ap & Lateral view)

937
39. Skull (AP & Lateral view)
40. I.V.P.
41. Cholecystography
42. Ba-meal follow through
43. Ba-enema
If abnormal, specify abnormalities: ...................................................................................
ELECTROGRADIUM Normal Abnormal

44. E.C.G.
45. Electro Encephalogram
If abnormal, specify abnormalities: ....................................................................................
46. CAT Scan
47. Ultra sonography of the
particular region
48. Endoscopy
49. Preliminary function test with Autospirometer
E. E.
P. E. F. R.
938
P. V. C.
Total Area Infected
939
Blank
940
REPRODUCTIVE AND CHILD
HEALTH CARE
SECTION - XVII
BLANK
942
To evaluate the efficacy of AYUSH AG TAB in management of Anaemia, loss of
appetite, leg crams, Bodyache, Weakness during Pregnancy etc.
I. BACKGROUND:
Despite of advanced technology, a high number of women continue to die during childbirth,
due to any cause, related to or aggravated by the Pregnancy or its management. Every minute,
the loss of a woman, shatters a family. Woman’s health have been neglected since many decades
due to gender inequality, poverty, illiteracy, working for the survival of mother is a human rights
imperative.
Pregnancy is a dynamic state, lot of physiological changes take place in hemodynamic and
other systems of pregnant woman in order to adopt the increasing demands of the growing fetus.
Ayurvedic classics had prescribed a particular diet and drug schedule for pregnant women.
These regimens support the pregnant women all through the antenatal, Intranatal and postnatal
period. The antenatal care is mainly intended to provide optimum nourishment to mother and
fetus; it prepares the reproductive system to withstand the changes during antenatal and intranatal
periods. It facilitates the metabolism of the growing fetus and prevents the obstetrical
complications.
II AIM:
1. To care minor ailments of pregnancy like vomiting, constipation, indigestion, minor
oedema etc.
2. To minimise obstetric complications such as pre-eclampsic problems, anemia, cervical
dystocia etc, to lower maternal and fetal mortality and morbidity etc.
III. Centres of the Study: 3 (three)
IV Sample size and Methods: 60
Sample size: Total case – 60, (20 each in three centres).
V. Investigational product and doses:
AYUSH –AG tablet – 500mg tab TDS from 3rd month onwards to till delivery
Vehicle – Milk or water
Follow-up: To be followed up to delivery.
943
VI. CRITERIA OF INCLUSION:
1. Pregnant women in the IIIrd month of Ist trimester with singleton pregnancy
2. Hb % between 8 and 10.5 gm/dl & Ferritin level less than 13 mg/l
3. Pregnancy not associated with any pre-existing medical illness such as TB, Epilepsy,
Hypertension, Diabetes, Severe anaemia etc
5. Pregnancy not associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic,
Toxemia, Pregnancy Induced Hypertension, Malformations of pelvis, Rh-
Incompatibility, Bad Obstetric History etc.
6. Pregnancy not associated with any Gynecological complications such as Fibroid
uterus, Ovarian cyst, Cervical carcinoma, Genital prolapse etc.
VII. CRITERIA OF EXCLUSION:
2. Pregnant women in the III trimester
3. Pregnancy associated with pre-existing medical illness like TB, Epilepsy, Hypertension,
Diabetes, Heart disease and severe anemia etc.
4. Grand multi-Para
5. Pregnancy associated with any Gynecological complications such as Fibroid uterus,
Ovarian cyst, Cervical carcinoma, Genital prolapse etc.
6. Pregnancy associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic Toxemia,
Pregnancy Induced Hypertension, Malformations of pelvis, Rh-Incompatibility, Bad
Obstetric History etc.
VIII. CRITERIA OF WITHDRAWAL:
1. 100% non-compliance
2. Irregular follow-ups
3. Pregnant woman developing severe obstetric complications
4. Non-availability of the selected cases
944
IX. ROUTINE EXAMINATION AND ASSESSMENT:
The full details of History and Physical Examination of the pregnant women will be
recorded as per the Proforma (form I & IA).
First visit of the pregnant woman will be considered as the initial assessment (whether it is
I or II trimester). Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up.
X. PERIOD OF STUDY:
7 months for each case. Total duration will be 6 months (For Ayush PG tablet) to
complete the trial at each centre.
XI. FOLLOW-UP:
To be followed up to delivery
XIII. CRITERIA FOR ASSESSMENT OF RESULTS:
Assessment of outcome of Pregnancy:
1. To assess the outcome of delivery as abortion, live birth and still birth
2. Type of delivery as Normal vertex, Breach, Instrumental or Caesarian section
The outcome of this programme will be considered significant if;
i) The woman passes antenatal period without any major complication
ii) Delivery being normal vaginal delivery
iii) Minimal third stage bleeding with normal expulsion of placenta – uncomplicated third
stage
iv) Giving birth to a normal, healthy, live child
XIV. STATISTICAL ANALYSIS:
Data of abortion, live birth, still birth and the type of delivery namely Normal vertex,
Breach, Instrumental and Caesarian will be completed and tabulated and analyzed using
XV. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visit by monitoring unit of CCRAS.
Data analysis will be undertaken at the monitoring unit of CCRAS.
XVI. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the trial is initiated.
945
Proforma - Antenatal Care
FORM-I: SCREENING PROFORMA
1. Code no. (of Clinical Trial)

2. Centre: __________________________________________________________________
3. Name of the subject: ________________________________________________________
4. Date of Birth: Age (in years):
5. Postal Address_____________________________________________________________
______________________________________________________________________________________
___________________________________________________________________________
Telephone number: Mobile: Landline:
CRITERIA OF INCLUSION:
6. Pregnant woman in the I and II trimesters with singleton pregnancy
7. Pregnancy not associated with any pre-existing medical illness such as Hypertension,
Tuberculosis, Epilepsy, Diabetes, and severe Anemia etc.
8. Pregnant woman age between 18 to 35 years
9. Pregnancy not associated with any Obstetric complications such as Ante-partum hemorrhage,
Partial Hydatidiform Mole, Pre-eclamptic Toxemia, Pregnancy Induced Hypertension,
Malformations of pelvis, Rh - Incompatibility, Bad Obstetric History etc.
10. Pregnancy not associated with Gynecological complications such as Fibroid uterus, Cervical
carcinoma, Genital prolapse, Ovarian cyst etc.
12. Pregnant woman in the III trimester
13. Pregnancy associated with any pre-existing medical illness such as Hypertension, Tuberculosis,
Epilepsy, Diabetes, and severe Anemia etc.
14. Pregnancy associated with Obstetric complications such as Antepartum hemorrhage, Partial
Hydatidiform Mole, Pre-eclamptic Toxemia, Pregnancy Induced Hypertension, Malformations
946
of pelvis, Rh - Incompatibility, Bad Obstetric History etc.
15. Pregnancy associated with Gynecological complications such as Fibroid uterus, Cervical
If ‘Yes’ to the 6-10 and ‘No’ to 11-15 above, recruit the subject for the trial, if recruited, subject
serial No._____________
Date:_____________ Signature of the Doctor / Investigator__________________
947
FORM - IA : HISTORY PROFORMA

2. Centre: __________________________________________________________________
5. Postal Address_____________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
D.O. A: __________________ D.O.D:_________________
1). Education:
Husband: 1. Nil 2. Upto Primary 3. Upto middle
Wife: 1. Nil 2. Upto Primary 3.Upto middle
2). Occupation: Husband : Wife: ______________________________________________
3). Family Income per month in Rs: _____________________________________________
4). Religion: 1. Hindu 2. Muslim 3. Sikh 4. Cristian 5. Others
PRENATAL HISTORY: Gestation at first visit (in weeks):
LMP: D/M/Y Gravida: Parity:
EDD: D/M/Y
MEDICAL HISTORY:
948
FAMILY HISTORY:
2). Diseases: Chronic illness:
Hypertension: Diabetes
Genetic disorders: (specify)
Other:
3). History of Multiple births, Molar pregnancy, Large baby, Post dated labour etc.
PAST MENSTRUAL HISTORY:
Menarche:
Menstruation - Duration Flow:
- Interval:
MARITAL HISTORY:
Age of marriage: Marital life (in years):
Consanguineous: Yes/No
PERSONAL HISTORY:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
HISTORY OF PREVIOUS PREGNANCY:
term term term Delivery Sex Alive Stillborn Weight
949
1). Instrumental delivery
2). IUFD
3). Hemorrhage- Antepartum: Intrapartum:
4). Bad Obstetric History (History of 3 or > abortion or fetal deaths)
5). Neonatal death: Reason:
6). Previous Caesarian Section: Reason:
7). PET / Eclampsia:
8). Ayurveda care taken during previous pregnancies: Y/N
HISTORY OF PRESENT PREGNANCY:
1). Nausea / Vomiting 10). Vaginal bleeding: I TM - II TM - III TM-
2). Heart burn 11). Oedema
3). Indigestion 12). Hb < 8gms %
4). Constipation 13). Heart disease
5). Giddiness 14). Diabetes
6). Hypertension 15). Uterine irritation/contractions
7). Varicose veins 16). Leg cramps
8). Hemorrhoids 17). Insomnia
9). Tingling & formication
Medication:
1). Whether received TT during this pregnancy: No. of doses
2). Whether received IFA, Calcium during this pregnancy
CLINICAL EXAMINATION:
General Examination: Blood Pressure: TPR:
1. Height 2. Weight
3. Head & Neck: Eyes: Mouth:
Neck: -Lymph gland
-Thyroid gland
4. Thorax:
950
Inspection: Breast: Nipple condition - Cracks Depression
Areola condition
Auscultation: Heart: Lungs:
5. Abdomen - Obstetrical Examination:
Inspection: Incisional Scars: Yes/No Over stretching of abdomen: Yes/No
Prominent veins over the abdomen: Yes/No
Palpation: Before 28th week of pregnancy:
Fundal Height:
Head size:
After 28th week of pregnancy: -
Presentation: Position: Lie:
Auscultation: Fetal Heart Rate:
7. Pelvic Examination:
Perineum, Vulva, Vagina, Cervix, Adnexa:
Clinical pelvimetry: Adequate – Yes/No
Presentation:
8. Treatment:
Ante-natal:
1. AYUSH AG tablet – 500 mg. 1 tablet TDS, after food, from 3rd month onwards of
pregnancy up to post delivery – 3 months
Vehicle: Milk or water
Odema during pregnancy
1. AYUSH PG tablet–500mg. 1 tablet BD, after breakfast and lunch, up to 30 days
10. Remarks:
Signature of the Investigator __________________
951
RCH Proforma - Antenatal Care
FORM-II: CLINICAL ASSESSMENT
(Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up)
1. Code no. (of Clinical Trial):

2. Centre: ___________________________________________________________________
5. Postal Address______________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Telephone:
6. Date of assessment:
7. Month of Assessment: Initial: 1st month 2nd month
3rd month 4th month 5th month 6th month
7th month: I Fortnight: II Fortnight:
9th month to till term: I week: II week: III week:
IV week: V week: VI week:
Follow Up Record:
Visit Gestation Fundal Ht Fetal FHR B.P. T.P.R
(weeks) (weeks) movements
I.
II.
III.
IV.
V.
VI.
VII.
952
VIII.
IX.
X.
XI.
XII.
XIII.
XIV.
XV.
XVI.
XVII.
XVIII.
XIX.
XX.
Associated Symptoms & Signs: (mention ‘Y’ for Yes, ‘N’ for No)
I II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII XVIII
Nausea
Vomiting
Heartburn
Indigestion
Constipation
Giddiness
Vaginal
bleeding
Odema
Varicose
veins
Leg cramps
Tingling &
formication
Insomnia
953
1.
2.
3.
4.
5.
Outcome of Pregnancy:
1. Outcome of delivery: (1. Abortion 2. Live birth 3. Stillbirth)
2. Type of delivery (1. Normal vertex 2. Breech 3. Instrumental 4. C.S)
3. Place of delivery (1. Home 2. S.C. 3. PHC/CHC 4. Nursing home 5. Hospital
4. Duration of labour (hrs):
5. Conducted by: (1. Dai 2. ANM/Nurse 3. Doctor 4. Relative 5. Other)
6. Safe Birth Kit used (1. Yes 2. No 3. Do not know)
7. Complication in the mother
(1.None 2. PPH 3. Eclampsia 4. Obstructed Labour 5. Retained Placenta)
8. Did mother require referral to higher health facility (1. Yes 2. No)
If yes, Reason————————————————————————————————
Condition of baby:
9. APGAR Scoring:
S.N Sign 0 Neonate’s 1 Neonate’s 2 Neonate’s
score Score score
1. Respiratory Absent Slow, Strong
effort irregular cry
weak cry
2. Heart rate Absent Slow,<100 > 100
3. Muscle tone Limp Some Active
flexion movement
of limbs
954
4. Reflex Absent Facial Cry
response to grimace
flicking of
foot
5. Color Blue-Pale Body pink, Complete-
Limbs blue ly pink
Severe asphyxia Score at one minute

Moderate asphyxia Score at five minutes
Mild asphyxia
No asphyxia
Stillborn/Macerated —————————————————————————
Cause —————————————————————————
10. Birth Weight (gms)
11. Sex of the baby:
12. Congenital malformation. 1. Yes 2. No
Completed:
Drop out: Reason: ____________________________
Died: Cause______________________________
Date: ______________ Signature of the Investigator___________________
955
FORM-III: LABORATORY INVESTIGAIONS - PARAMETERS

2. Centre: ___________________________________________________________________
5. Postal Address______________________________________________________________
___________________________________________________________________________
____________________________________________________________________________
Telephone:
1). ABO & Rh: Wife - Husband:
2). VDRL _______________________
3). HIV I & II ___________________
4) HBS Ag _____________________
5. Hb gm%: ____________________
6. Urine: Routine: _________________________ Microscopic: _________________________
(Investigations 1-4 will be done initially only)
Date: __________________ Signature of Investigator ____________________
7. Hb% _____________________________
8. Clotting time _______________________
9. Bleeding time _______________________
10. Prothrombin time ____________________
11. Fibrinogen time ______________________
956
12. PCV (%) __________________________
13. Blood Sugar PP______________________
14. Blood Urea _________________________
15. Serum Creatinine _____________________
16. SGPT _____________________________
17. SGPT _____________________________
18. Serum Bilirubin ______________________
19. USG: ______________________________
20. Urine: Routine: _______________________ Microscopic: __________________________
Date:____________ Signature of the Investigator_____________________
957
To evaluate the efficacy of AYUSH PG TAB in non pathological
mild to moderate pedal edema or generalized edema during pregnancy.
I. BACKGROUND:
Despite of advanced technology, a high number of women continue to die during childbirth,
due to any cause, related to or aggravated by the Pregnancy or its management. Every minute,
the loss of a woman, shatters a family. Woman’s health have been neglected since many decades
due to gender inequality, poverty, illiteracy, working for the survival of mother is a human rights
imperative.
Pregnancy is a dynamic state, lot of physiological changes take place in hemodynamic and
other systems of pregnant woman in order to adopt the increasing demands of the growing fetus.
Ayurvedic classics had prescribed a particular diet and drug schedule for pregnant women.
These regimens support the pregnant women all through the antenatal, Intranatal and postnatal
period. The antenatal care is mainly intended to provide optimum nourishment to mother and
fetus; it prepares the reproductive system to withstand the changes during antenatal and intranatal
periods. It facilitates the metabolism of the growing fetus and prevents the obstetrical
complications.
II AIM:
1. To evaluate the efficacy of AYUSH PG TAB in non pathological mild to
moderate pedal edema or generalized edema during pregnancy.
2. To minimise obstetric complications such as pre-eclampsic problems,
III. Centres of the Study: 3 (three)
IV: Sample size and Methods: 60
Sample size: Total case – 60, (20 each in three centres).
V. Investigational product and doses:
AYUSH – PG tablet – 500mg tab BD, for 30 days in cases of mild to moderate pedal edema
or generalized edema during pregnancy.
Design of study: Open trial single blind.
Follow-up: weekly.
958
VI. CRITERIA OF INCLUSION:
1. Pregnant women with non pathological mild to moderate pedal edema or generalized
edema during pregnancy.
2. Pregnancy not associated with any pre-existing medical illness such as TB, Epilepsy,
Hypertension, Diabetes, Severe anaemia etc
4. Pregnancy not associated with any Obstetric complications such as Ante-partum
5. Pregnancy not associated with any Gynecological complications such as Fibroid uterus,
ovarian cyst, cervical carcinoma, Genital prolapse etc.
VII. CRITERIA OF EXCLUSION:
2. Any other type of oedema during Pregnancy associated with pre-existing medical
illness like TB, Epilepsy, Hypertension, Diabetes, Heart disease and severe anemia etc.
3. Grand multi-Para
4. Pregnancy associated with any Gynecological complications such as Fibroid uterus,
ovarian cyst, cervical carcinoma, Genital prolapse etc.
5. Pregnancy associated with any Obstetric complications such as Ante-partum
VIII. CRITERIA OF WITHDRAWAL:
3. Pregnant woman developing severe obstetric complications
4. Non-availability of the selected cases
The full details of History and Physical Examination of the pregnant women will be
recorded as per the Proforma (form I & IA).
959
First visit of the pregnant woman will be considered as the initial assessment (whether it is
I or II trimester). Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up.
X. PERIOD OF STUDY:
7 months for each case. Total duration will be 6 months (For Ayush PG tablet) to
complete the trial at each centre.
XI. FOLLOW-UP:
To be followed up to delivery
XIII. CRITERIA FOR ASSESSMENT OF RESULTS:
Assessment of outcome of Pregnancy:
1. To assess the outcome of delivery as abortion, live birth and still birth
2. Type of delivery as Normal vertex, Breach, Instrumental or Caesarian section
The outcome of this programme will be considered significant if;
i) The woman passes antenatal period without any major complication
ii) Delivery being normal vaginal delivery
iii) Minimal third stage bleeding with normal expulsion of placenta – uncomplicated third stage
iv) Giving birth to a normal, healthy, live child
XIV. STATISTICAL ANALYSIS:
Data of abortion, live birth, still birth and the type of delivery namely Normal vertex,
Breach, Instrumental and Caesarian will be completed and tabulated and analyzed using
XV. TRIAL MONITORING AND DATA ANALYSIS:
XVI. ETHICAL REVIEW:
should give clearance certificate before the trial is initiated.
960
Proforma - Antenatal Care

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
6. Pregnant woman in the I and II trimesters with singleton pregnancy
7. Pregnancy not associated with any pre-existing medical illness such as Hypertension,
Tuberculosis, Epilepsy, Diabetes, and severe Anemia etc.
8. Pregnant woman age between 18 to 35 years
9. Pregnancy not associated with any Obstetric complications such as Ante-partum hemorrhage,
Partial Hydatidiform Mole, Pre-eclamptic Toxemia, Pregnancy Induced Hypertension,
Malformations of pelvis, Rh - Incompatibility, Bad Obstetric History etc.
10. Pregnancy not associated with Gynecological complications such as Fibroid uterus, Cervical
12. Pregnant woman in the III trimester
13. Pregnancy associated with any pre-existing medical illness such as Hypertension, Tuberculosis,
Epilepsy, Diabetes, and severe Anemia etc.
14. Pregnancy associated with Obstetric complications such as Antepartum hemorrhage, Partial
Hydatidiform Mole, Pre-eclamptic Toxemia, Pregnancy Induced Hypertension, Malformations of
961
pelvis, Rh - Incompatibility, Bad Obstetric History etc.
15. Pregnancy associated with Gynecological complications such as Fibroid uterus, Cervical
serial No._____________
Date:______________ Signature of the Doctor / Investigator
962
FORM-I A: HISTORY PROFORMA

2. Centre: __________________________________________________________________
5. Postal Address_____________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
D.O. A: D.O.D:
1). Education:
Husband: 1. Nil 2. Upto Primary 3. Upto middle
Wife: 1. Nil 2. Upto Primary 3. Upto middle
2). Occupation: Husband: ______________ Wife: ________________
3). Family Income per month in Rs: __________________________________
4). Religion:
1.Hindu 2.Muslim 3.Sikh 4.Cristian 5.Others
5). Working Status:
1. Not gainfully employed 2. Casual worker
PRENATAL HISTORY: Gestation at first visit (in weeks):
EDD: D/M/Y
963
MEDICAL HISTORY:
FAMILY HISTORY:
2). Diseases: Chronic illness: Hypertension: Diabetes
Other:
3). History of Multiple births, Molar pregnancy, Large baby, Post dated labour etc.
Menarche:
- Interval:
MARITAL HISTORY:
PERSONAL HISTORY:
Likes:
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2). IUFD
1). Nausea / Vomiting 10). Vaginal bleeding: I TM - II TM - III TM-
2). Heart burn 11). Oedema
3). Indigestion 12). Hb < 8gms %
4). Constipation 13). Heart disease
5). Giddiness 14). Diabetes
6). Hypertension 15). Uterine irritation/contractions
7). Varicose veins 16). Leg cramps
8). Hemorrhoids 17). Insomnia
9). Tingling & formication
MEDICATION:
1). Whether received TT during this pregnancy: No. of doses
2). Whether received IFA, Calcium during this pregnancy
CLINICAL EXAMINATION:
General Examination: Blood Pressure: TPR:
1. Height 2. Weight
3. Head & Neck: Eyes: Mouth:
Neck: - Lymph gland
- Thyroid gland
4. Thorax:
965
Inspection: Breast: Nipple condition - Cracks - Depression
Areola condition
Auscultation: Heart: Lungs:
5. Abdomen - Obstetrical Examination:
Inspection: Incisional Scars: Yes/No Over stretching of abdomen: Yes/No
Prominent veins over the abdomen: Yes/No
Palpation: Before 28th week of pregnancy: -
Fundal Height:
Head size:
After 28th week of pregnancy: -
Presentation: Position: Lie:
Auscultation: Fetal Heart Rate:
7. Pelvic Examination:
Perineum, Vulva, Vagina, Cervix, Adnexa:
Clinical pelvimetry: Adequate – Yes/No
Presentation:
8. Treatment:
Ante-natal:
1. AYUSH AG tablet – 500 mg. 1 tablet TDS, after food, from 3rd month onwards of
pregnancy up to post delivery – 3 months
Odema during pregnancy
1. AYUSH PG tablet–500mg. 1 tablet BD, after breakfast and lunch, up to 30 days
10. Remarks:
966
(Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up)

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Telephone:
7. Month of Assessment:
Initial: 1st month 2nd month 3rd month
4th month 5th month 6th month
9th month to till term: I week: II week: III week:
IV week: V week: VI week:
Follow Up Record:
Visit Gestation Fundal Ht Fetal FHR B.P. T.P.R
(weeks) (weeks) movements
I.
II.
III.
IV.
V.
VI.
967
VII.
VIII.
IX.
X.
XI.
XII.
XIII.
XIV.
XV.
XVI.
XVII.
XVIII.
XIX.
XX.
Associated Symptoms & Signs: (mention ‘Y’ for Yes, ‘N’ for No)
I II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII XVIII
Nausea
Vomiting
Heartburn
Indigestion
Constipation
Giddiness
Vaginal
bleeding
Odema
Varicose
veins
Leg cramps
Tingling &
formication
Insomnia
968
1.
2.
3.
4.
5.
Outcome of Pregnancy:
1. Outcome of delivery: (1. Abortion 2. Live birth 3. Stillbirth)
2. Type of delivery (1. Normal vertex 2. Breech 3. Instrumental 4. C.S)
3. Place of delivery (1. Home 2. S.C. 3. PHC/CHC 4. Nursing home 5. Hospital
4. Duration of labour (hrs):
5. Conducted by: (1. Dai 2. ANM/Nurse 3. Doctor 4. Relative 5. Other)
6. Safe Birth Kit used (1. Yes 2. No 3. Do not know)
7. Complication in the mother
(1.None 2. PPH 3. Eclampsia 4. Obstructed Labour 5. Retained Placenta)
8. Did mother require referral to higher health facility (1. Yes 2. No)
If yes, Reason————————————————————————————————
Condition of baby:
9. APGAR Scoring:
S.N Sign 0 Neonate’s 1 Neonate’s 2 Neonate’s
score Score score
1. Respiratory Absent Slow, Strong
effort irregular cry
weak cry
2. Heart rate Absent Slow,<100 > 100
3. Muscle tone Limp Some Active
flexion movement
of limbs
969
4. Reflex Absent Facial Cry
response to grimace
flicking of
foot
5. Color Blue-Pale Body pink, Complete-
Limbs blue ly pink
Severe asphyxia Score at one minute

Moderate asphyxia Score at five minutes
Mild asphyxia
No asphyxia
Stillborn/Macerated ——————————
Cause ——————————
10. Birth Weight (gms)
11. Sex of the baby:
12. Congenital malformation. 1. Yes 2. No
Completed:
Drop out: Reason: ____________________________
Died: Cause______________________________
970

2. Centre: __________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Telephone:
2). VDRL ____________________
3). HIV I & II ________________
4) HBS Ag ___________________
5. Hb gm%: __________________
6. Urine: Routine: ________________________ Microscopic: __________________________
Date: ________________ Signature of Investigator ____________________
7.. Hb% ___________________________
8. Clotting time ___________________
9. Bleeding time __________________
10. Prothrombin time _______________
11. Fibrinogen time ________________
971
12. PCV (%) ______________________
13. Blood Sugar PP_________________
14. Blood Urea ____________________
15. Serum Creatinine _______________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
19. USG: _________________________
20. Urine: Routine: _______________________ Microscopic: ____________________
972
“To evaluate the effect of AYUSH B.R. Leham on growth and development, immunity
in infants”
I. BACKGROUND:
Approximately one million newborn deaths could be avoided every year through the
promotion of optimal newborn care practices. To be most effective, these interventions need site-
specific information on existing newborn practices, barriers and facilitating factors for adopting
optimal practices.
While India’s target under the MDG for mortality of children under age 5 is 38 per 1,000
live births, the number of children who die before their fifth birthday stands at 76 at present. Infant
mortality rate in India stands at 57 per 1,000 live births while neonatal mortality rate - deaths in
the first month of life - stands at 43 per 1,000 live births. According to the report, brought out by
the International Partnership for Maternal, Newborn and Child Health (MNCH), an umbrella
organisation comprising about 240 members such as UNICEF, WHO and Save the Children,
India’s average annual rate of reduction of child deaths between 1990 – 2006, has been just
2.6%. If India wants to achieve the agreed targets by 2015, the required rate to reduce child and
maternal mortality will have to be 7.6% from 2007-2015.
Proper neonatal care during immediate neonatal period and infancy will bring down the
Infant and neonatal mortality rate effectively, prevent ailments of childhood and ensure optimum
physical as well as mental growth of the baby. This can be done through package of the services
comprising the nutrition, immunization and periodical health check ups. Ayurveda, the holistic
system of medicine can render the above said package of services to the neonate in a
comprehensive and integrated manner. The neonatal care described in Ayurveda is advanced and
it advocates neutraceutical drugs use. Neutraceutical kinds of Rasayana drugs act as growth
promoters through their multiple actions and can prevent the ailments, which occur during the
neonatal period to infantile period. The present study is under taken to promote the Neonatal and
infantile care as per Ayurveda to ensure optimum growth and development of the child.
II AIM:
1. To Ensure proper growth and development of Neonate.
2. To Enhance immunity
3. To support Physiological functions of baby like digestion, absorption and assimilation
4. To prevent frequent episodes of neonatal and childhood ailments.
III. CENTRES OF THE STUDY: 2
973
IV: SAMPLE SIZE AND METHODS:
Treatment: AYUSH– Bal Rakshak Leham – 500 mg, once in a day during first month
increase in first month of treatment followed by increment of 500 mg every month till the
completion of trial period
Duration of ‘Leham’ administration: Six month
Duration of study: 12 months
Design of study: Open trial single blind.
Level of Study: OPD
Follow-up: To be followed up to one year age.
V. CRITERIA OF INCLUSION:
1. Healthy, full term (AGA) baby.
2. Baby born by vaginal spontaneous delivery.
3. Baby has APGAR score in between 8 -10 at one minute.
VI. CRITERIA OF EXCLUSION:
1. Baby has APGAR score less than 8 at one minute.
2. Full Term babies with SGA and LGA.
3. Pre term and post term babies with AGA/SGA/LGA.
4. Baby born by dystocia, delayed labour.
5. Baby with congenital anomalies.
6. Baby with Rh – incompatability.
7. Baby with Pathological neonatal icterus, cyanosis, anemia and other diseases.
8. Baby with birth asphyxia
9. Baby with birth injuries like fracture, dislocation of the joint, paralysis etc.
10. Baby with HIE (Hypoxic ischemic encephalopathy).
11. Baby born to the women suffering with metabolic/hormonal disorders and TORCH
infection.
12. Baby is associated with severe septicaemia, meningitis or any other life threatening disorfer.
974
VII. CRITERIA OF WITHDRAWAL:
3. Baby developing any severe systemic diseases during the trial period.
4. Non-availability of the selected cases at due follow ups
The full details of ‘History and Physical Examination’ of the baby will be recorded as per
the Proforma (form I & IA) in hard and soft copy at first and subsequently on each visit till the
age of 12 months.
First visit of the baby will be considered as the initial assessment (after the delivery).
XI. PERIOD OF STUDY: 12 months for each case. Total duration will be five years to
complete the trial at each Centre.
X. FOLLOW-UP: To be followed up monthly till 12 months age of the baby.
XI. CRITERIA FOR THE ASSESSMENT OF RESULTS:
Assessment of outcome: Following criteria shall be adopted for the assessment-
1. The growth of children shall be assessed by means of Anthropometrical parameters noted
on the growth chart.
2. Developmental assessment shall be carried out as per the Gesell’s Development Schedules
The outcome of the study will be considered significant if-
i) There is significant reduction or does not develop any severe diseases up to 12 months
period.
ii) There is optimum gain in Anthropometric measurements at the given age.
iii) Reduction in or absence of seasonal disorders.
XII. STATISTICAL ANALYSIS:
Data gathered during the trial period on the preformed format including the Anthropometric
measurements will be analyzed by using appropriate statistical methods.
XIII. TRIAL MONITORING AND DATA ANALYSIS:
975
XIX. ETHICAL REVIEW:
should give clearance certificate before the Project as initiated. Patient’s Information Sheet and
informed consent form should be submitted along with Project proposal for approval by IEC/Head
of the Institution. Both should be maintained in duplicate with one copy given to the patient at the
time of entry to
976

2. Centre: __________________________________________________________________
3. Name of the subject: _____________________Name of the mother__________________
4. Date of Birth: Age (in months):
5. Postal Address: ____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
6. Healthy, full term (AGA) baby.
7. Baby born by vaginal spontaneous delivery.
8. Baby has APGAR score in between 8 -10 at one minute.
9 Baby has APGAR score less than 8 at one minute.
10 Full Term babies with SGA and LGA.
11 Pre term and post term babies with AGA/SGA/LGA.
12 Baby born by dystocia, delayed labour.
13 Baby with congenital anomalies.
14 Baby with Rh – incompatability.
15 Baby with Pathological neonatal icterus, cyanosis, anemia and other diseases.
16 Baby with birth asphyxia
17 Baby with birth injuries like fracture, dislocation of the joint, paralysis etc.
18 Baby with HIE (Hypoxic ischemic encephalopathy).
19 Baby born to the women suffering with metabolic/hormonal disorders and TORCH infection.
20 Baby is associated with severe septicaemia, meningitis or any other life threatening disorfer.
serial No._____________
Date: Signature of the Doctor / Investigator
977
2. Centre: __________________________________________________________________
3. Name of the Subject: ___________________Name of the Mother____________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
D.O.R (Date of registration):
1). Education:
Father: 1.Nil 2.Upto Primary 3.Upto middle
Mother: 1.Nil 2.Upto Primary 3.Upto middle
2). Occupation: Father: Mother:
3). Family Income per month in Rs:
4). Religion: 1.Hindu 2.Muslim 3.Sikh
4.Christian 5.Others
5). Working Status of mother:
1. Not gainfully employed 2. Casual worker
PRENATAL HISTORY: Gestation ageat first visit (in weeks):
EDD: D/M/Y
978
MEDICAL HISTORY OF MOTHER:
Surgery: Communicable diseases:
PERSONAL HISTORY OF MOTHER:
Likes:
MOTHER’S PAST OBSTETRIC HISTORY:


2). IUFD
1. Vaginal bleeding: I TM - II TM - III TM-
2. Oedema
3. Anemia
4. Heart disease
979
5. Diabetes
6. Hypertension
HISTORY OF PRESENT LABOUR:
1. Type of labour: Normal/Abnormal (Specify)
2. Duration of labour:
3. Fetal distress: Present / Absent
4. Membranes ruptured: Spontaneously/Artificially…………….. hours before delivery
5. Character of amniotic fluid: Clear/Meconium stained/Foul smelling
Amount: Scanty/Normal/Excessive
6. Placenta and membranes: Healthy/Unhealthy Retroplacental clots Yes /No
7. Cord: Prolapsed/Around neck body
8. Drugs and treatment given ……………………..............……………………………………
BABY:
Date and time of Birth……………………Sex: Male/Female
Condition at birth: Active/Asphyxiated…………………………………….........................…
APGAR Scoring: Score at one minute Score at five minutes
Severe asphyxia
Moderate asphyxia
Mild asphyxia No asphyxia
GENERAL EXAMINATION
Moulding: Normal/Excessive/Nil
Caput: Yes/No Skin…………………………
Eyes…………........….....… Limbs………………....…….
Mouth…………………...... Genitalia………………...…..
Heart……………….....….. Lungs……………….............
Abdomen……………….... Anus………………..............
Other findings…………………………………………………....................
980
ANTHROPOMETRIC MEASUREMENTS
Weight……………
Crown Rump Length……….................. Head Circumference……..……
Mid Arm Circumference………........…. Chest Circumference………….
TREATMENT:
1.AYUSH –Bal Rakshak leham – 500mg once in a day during first month increase 500 mg every
month up to 6 months.
REMARKS:
981
(Monthly follow up till 12th month)

2. Centre: __________________________________________________________________
3. Name of the subject: ____________________Name of the mother ___________________
5. Postal Address_____________________________________________________________
______________________________________________________________________________________________________________________________________
Telephone:
7. Month of Assessment:
Initial: 1st month 2nd month 3rd month
4th month 5th month 6th month 7th month
8th month 9th month 10th month 11th month
12th month
CLINICAL CHART OF BABY

Parameters Initial MONTHLY ASSESSMENT
I II III IV V VI VII VIII IX X XI XII
Temperature
Heart Rate
Respiration
Urine
Stool
Vomit
Jaundice
Weight
982
GROWTH CHART OF BABY (ANTHROPOMETRIC ASSESSMENT)
Parameters Initial MONTHLY ASSESSMENT

I II III IV V VI VII VIII IX X XI XII
1. Standard 3.25 4.15 4.95 5.7 6.35 7.0 7.5 8.0 8.5 8.9 9.2 9.55 9.85
(Weight in Kg)
Present weight
2. Standard
(CHL in c. m.)
Present Crown
to heel
length
3. Standard
(CRL in c. m.)
Present Crown
to rump length
4. Standard
(Head circumf-
erence in c. m.)
Present Head
circumference
5. Standard
(Chest
circumference
in c. m.)
Present Chest
circumference
Standard Mid
arm
circumference
in c.m.
Present Mid
arm
circumference
983

2. Centre: ___________________________________________________________________
3. Name of the subject: ____________________Name of the mother____________________
5. Postal Address______________________________________________________________
____________________________________________________________________________
Telephone:
7. Investigations:
Blood:
a) TLC, DLC, Hb%: _________________________________
b) Blood Group: ABO Rh______________________________
c) Blood Urea ______________________________________
d) Serum Creatinine __________________________________
e) SGOT __________________________________________
f) SGPT __________________________________________
g) Alkaline Phophatase _______________________________
h) Serum Bilirubin ___________________________________
Urine: Routine: ___________________________________
Microscopic: _______________________________
Any other:
984
TO EVALUATE THE EFFICACY OF AYUSH PK-AVALEHA IN PREVENTING
POSTPARTUM COMPLICATIONS AND PUERPERIAL CARE.
INTRODUCTION:
Puerperium begins as soon as the Placenta is expelled and lasts for approximately 6
weeks. During this phase woman’s body tissues, especially pelvic organs revert back
approximately to the pre pregnant state both anatomically and physiologically by the process called
involution. In the immediate Postpartum, apart from involution, general physiological changes such
as raise in the pulse rate, reactionary rise in temperature may be there. Bladder becomes
oedematous with hyperaemic and woman becomes relatively insensitive to the raise intra vesicle
pressure due to the trauma sustained to the nerve plexus during delivery, the bladder may be over
distended without any desire to pass urine. Stagnation of the urine along with a devitalized bladder
wall contributes to the urinary tract infection in puerperium.
Treatment:
1. Ayush PK Avaleha: 5 gm twice daily with milk or water for 45 days after delivery.
AIMS
1. To support health status of mother during puerperium
2. To reduce perinatal mortality and morbidity
3. To prevent complications of Postpartum
4. To ensure early sub involutions of uterus.
V. CRITERIA OF INCLUSION:
1. Age between 20 – 35 years
2. Puerperium without any severe complications like Post partum haemorrhage,
Sub involution of uterus etc.
3. Normally delivered /Caesarian delivery
4. Not associated with postnatal eclampsia, Puerperal psychosis, Post-gestational diabetes etc.
985
1. Puerperium associated with severe Postpartum haemorrhage
2. Cases with acute puerperal inversion of Uterus
3. Cases associated with Postnatal eclampsia, Puerperal psychosis, Post gestational diabetes etc.
4. Puerperal woman aged below 15 and above 35 years of age.
VII. CRITERIA OF WITHDRAWAL:
1. Patients not complying with treatment
2. Development of complications like haemorrhage, convulsion etc.
3. Patients left the study in between
The full details of history and physical examinations of the patients will be recorded as per
the Proforma (Forms 1& 1A) Clinical assessment will be done before drug administration on
1st , 2nd , 3rd , 4th ,5th ,6th ,7th , 15th ,30th 45th day during drug treatment period ,30th ,60th
,90th day during follow-up (Form-II). Laboratory investigations carried out according to Form-III.
IX. PERIOD OF STUDY:
3 months for each case. Total duration will be 1 year to complete the trial at each centre.
X. FOLLOW –UP: The follow-ups will be carried out after 30th, 60th, and 90th day.
XI. CRITERIA FOR ASSESSMENT OF RESUTS:
Completion of puerperium without any complications, early involution of Uterus, proper
onset and maintenance of lactation, improvement in general health status of mother will be
considered as significant improvement.
XII. STATISTICAL ANALYSIS:
Data on involution of Uterus, prevention of the complications of puerperium, lactation
maintenance will be tabulated and analysed using appropriate statistical methods.
XIII. TRAIL MONITORING AND DATA ANALYSIS:
Data analysis will be undertaken at monitoring unit of CCRAS.
Each participating Centres Institutional Ethical Committee (IEC) or Head of Institution
should give clearance certificate before the Project is initiated. Patients information sheet and
informed consent form should be submitted in duplicate with one copy given to the patient at the
986

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
____________________________________________________________________________
2. Puerperium without any severe complications like Post partum haemorrhage, Subinvolution of
uterus etc.
3. Normally delivered
4. Not associated with postnatal eclampsia, Puerperal psychosis, Post-gestational diabetes etc.
3. Cases associated with postnatal eclampsia, Puerperal psychosis, Post gestational diabetes etc.
5. If ‘Yes’ to the 6-9 and ‘No’ to 10-13 above, recruit the subject for the trial, if recruited,
subject serial No._____________
987
2. Centre: __________________________________________________________________
5. Postal Address______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
D.O. A: D.O.D:
1). Education:
Husband:
1. Nil 2. Upto Primary 3.Upto middle
Wife:
1.Nil 2.Upto Primary 3.Upto middle
2). Occupation: Husband: Wife:
4). Religion: 1.Hindu 2.Muslim 3.Sikh 4.Cristian 5.Others
PRENATAL HISTORY: Gravida: Parity:
LMP: D/M/Y
EDD: D/M/Y
988
MEDICAL HISTORY:
FAMILY HISTORY:
Other:
3). History of Multiple births:
Menarche:
- Interval:
MARITAL HISTORY:
PERSONAL HISTORY:
Likes:
989
2). IUFD
5). Neonatal death – Reason:
6). Previous Caesarian Section - Reason:
7). PET Eclampsia:
LABOUR HISTORY: Date Time:
Type of Delivery:
Duration of Labour: First stage: Hrs. mnts
Second stage: Hrs mnts
Third stage: Hrs mnts
Condition of Baby: Active / Asphyxiated / still birth / macerated
APGAR Score: __________________
Treatment at Birth: ________________
Delivery of placenta & membranes:
Delivered Time:___________________
Spontaneous / Helped out / Manually Removed:
Type of Placenta:
Placenta & Membranes: Complete / Incomplete:
Weight: __________ Cord length: ___________ Cord insertion: ______________
Any abnormality:
Total blood loss: ml
Perineum: Intact / Episiotomy:
Laceration
Medicines given:
Condition of mother following delivery:
990
Pulse: B.P Temp.
Uterus: Hard / Soft
Vaginal bleeding:
POSTNATAL HISTORY:
Fever: Condition of Breast:
Excessive vaginal bleeding: Onset of Milk
Breast fullness with fever: Mental condition:
Burning on passing urine: Foul smelling vaginal discharge:
Puerperal Psychosis:
TREATMENT:
Mother:
1. Ayush - PK Avaleha : 5 gm twice daily with milk or water for 45 days after delivery
- Vehicle: Milk or water
991
FORM-II: CLINICAL ASSESMENT
2. Centre: ____________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Follow-up chart of puerperium:
CLINICAL CHART OF PUERPERIUM

I day II day III day IV day V day VI day VII day
Date:
Temperature Fundal (in cm)

M E M E M E M E M E M E M E
height above
Pubic symphysis
F C
104.9 40.5 20
104.0 40 17.5
103.1 39.5 15
102.2 39 12.5
101.3 38.5 10
100.4 38 7.5
99.5 37.5 5
98.6 37 2.5
97.7 36.5
96.8 36
95.9 35.5
992
Pulse M
E
Respir M
ation E
B.P M
E
Lochia
Urine
Motion
Weight
Episiotomy wound
a). Discharges-
Yes/No
(Blood/Pus/Serous)
b).Colour of the
wound –
Pinkish/other
c). granulation
formed /not
d). condition of
the wound –
healthy/not healthy
Lactation
993
FORM-III: LABORATORY INVESTIGATIONS - PARAMETERS

2. Centre: __________________________________________________________________
Name of the subject: __________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Telephone:
2). VDRL ________________
3). HIV I & II _____________
4) HBS Ag --------------------________________
5. Hb gm%: ___________________
6. Urine: Routine: _______________________ Microscopic: __________________________
Date: _____________ Signature of Investigator ____________________
7. Hb% ___________________________
8. Clotting time ___________________
9. Bleeding time __________________
11. Fibrinogen time ________________
12. PCV (%) ______________________
994
13. Blood Sugar PP_________________
14. Blood Urea ____________________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
19. USG: _________________________
995
TO EVALUATE THE EFFICACY OF AYUSH SS-GRANULES TO ENSURE
QUALITY & QUANTITY OF BREAST MILK
I INTRODUCTION
There will be increased thirst in early puerperium is due to loss of fluid during labour in the
lochia, diuresis and perspiration. Slight intestinal paresis leads to constipation. Colostrum secretion
from breasts becomes more abundant.
Post-natal care mainly aims at management of postnatal ailments and supporting involution
of genital organs, onset and maintenance of lactation, betterment of general health status of mother.
II. AIMS:
1. To ensure proper lactation and quality, quantity of breast milk
III. Centres of the Study: 03 (Three)
IV. Sample size and Methods:
Ayush SS granules: 10gm. BD, after breakfast and at bedtime through out lactation period.
Duration: 3 months
Design of the Study: Open trial
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS. Data
analysis will be undertaken at monitoring unit of CCRAS.
Each participating Centres Institutional Ethical Committee (IEC) or Head of Institution
should give clearance certificate before the Project is initiated. Patients information sheet and
informed consent form should be submitted in duplicate with one copy given to the patient at the
Efficacy parameters: Test for quality & quantity of milk-
Parameters of Assessment:
996
1. Improvement in Quantity of milk
2. Assessment of pre and post treatment serum prolactin levels
3. Assessment of weight gain by child
4. Analysis of breast-milk samples [Proteins, Lactose (Carbohydrate), Fat, Minerals
(Calcium, Phosphorous)]
5. Global Investigator’s assessment
6. Global Subject’s assessment
7. Safety Evaluation
997

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
____________________________________________________________________________
___________________________________________________________________________
7. Insufficient lactation (Indicators of insufficient lactation: 1.lactating mother feels that secretion is
not sufficient,2. Baby cries a lot,3. Inadequate weight gain,4.Development of mal-nutrition)
8. Puerperium without any severe complications like Post partum haemorrhage, Subinvolution of
uterus etc.
9. Normally delivered
10. Not associated with Postnatal eclampsia, Puerperal psychosis, Post-gestational diabetes etc.
13. Cases associated with Postnatal eclampsia, Puerperal psychosis, Post gestational diabetes etc.
15. Mastitis and breast abscess
serial No._____________
998

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
D.O. A: D.O.D:
1). Education:
Husband:
Wife:
2). Occupation: Husband: Wife:
4). Religion: 1.Hindu 2.Muslim 3.Sikh 4.Cristian 5.Others
PRENATAL HISTORY: Gravida: Parity:
LMP: D/M/Y
EDD: D/M/Y
999
MEDICAL HISTORY:
FAMILY HISTORY:
Other:
3). History of Multiple births:
Menarche:
- Interval:
MARITAL HISTORY:
PERSONAL HISTORY:
Likes:
1000
2). IUFD
5). Neonatal death – Reason:
6). Previous Caesarian Section - Reason:
7). PET Eclampsia:
LABOUR HISTORY: Date Time:
Type of Delivery:
Duration of Labour: First stage: Hrs. mnts
Second stage Hrs mnts
Third stage Hrs mnts
Condition of Baby: Active / Asphyxiated / still birth / macerated
APGAR Score:
Treatment at Birth:
Delivery of placenta & membranes:
Delivered Time:
Spontaneous / Helped out / Manually Removed:
Type of Placenta:
Placenta & Membranes: Complete / Incomplete:
Weight: Cord length: Cord insertion:
Any abnormality:
Total blood loss: ml
Perineum: Intact / Episiotomy:
Laceration
Medicines given:
1001
Condition of mother following delivery:
Pulse: B.P Temp.
Uterus: Hard / Soft
Vaginal bleeding:
POSTNATAL HISTORY:
Fever: Condition of Breast:
Excessive vaginal bleeding: Onset of Milk
Breast fullness with fever: Mental condition:
Burning on passing urine: Foul smelling vaginal discharge:
Puerperal Psychosis:
TREATMENT:
AYUSH SS granules: 10gm. BD, after breakfast and at bedtime through out lactation period.
1002
FORM-II: CLINICAL ASSESMENT
2. Centre: ____________________________________________________________________
3. Name of the subject: _________________________________________________________
5. Postal Address______________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Efficacy parameters: Test for quality & quantity of milk
Parameters of Assessment:
1. Improvement in Quantity of milk
3. Assessment of weight gain by child
4. Analysis of breast-milk samples [Proteins, Lactose (Carbohydrate), Fat, Minerals (Calcium,
Phosphorous)]
5. Global Investigator’s assessment
6. Global Subject’s assessment
7. Safety Evaluation
1003
FORM-III: LABORATORY INVESTIGATIONS - PARAMETERS

2. Centre: ___________________________________________________________________
5. Postal Address_____________________________________________________________
___________________________________________________________________________
____________________________________________________________________________
Telephone:
7. Investigations: Blood(Routine)
2). VDRL ________________
3). HIV I & II _____________
4) HBS Ag ______________________________
5. Hb gm%: ___________________
Phosphorous)]
Date: _____________ Signature of Investigator ____________________
7. Hb% ___________________________
8. Clotting time ___________________
9. Bleeding time __________________
1004
11. Fibrinogen time ________________
12. PCV (%) ______________________
13. Blood Sugar PP_________________
14. Blood Urea ____________________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
Phosphorous)]
1005
BLANK
1006
CLINICAL SAFETY OF SOME
AYURVEDIC AND SIDDHA DRUGS
SECTION - XVIII
1007
Blank
1008
OPEN OBSERVATIONAL STUDY ON CLINICAL
SAFETY OF SELECTED AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS
Drug: Study Code:

AND SIDDHA
1009
Blank
1010
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
I. BACKGROUND
The use of metals in therapeutic drugs has become increasingly important over the last
couple of decades; Ayurveda recognizes their use long before that. Rasashastra, one among the
subspecialties of Ayurvedic Pharmaceuticals and Siddha classics have specified therapeutic use of
metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs required in lesser
doses, causes no distaste unlike herbal drugs and faster in action, these practices became popular
and widely accepted and safely used since long.1
Heavy metals are chemical elements with a specific gravity that is at least 5 times the
specific gravity of water. There are 35 metals that concern us because of occupational or
residential exposure; 23 of these are the heavy elements or “heavy metals”: antimony, arsenic,
bismuth, cadmium, cerium, chromium, cobalt, copper, gallium, gold, iron, lead, manganese, mercury,
nickel, platinum, silver, tellurium, thallium, tin, uranium, vanadium, and zinc (Glanze 1996).
Interestingly, small amounts of these elements are common in our environment and diet and are
actually necessary for good health, but inappropriate dosage forms of any of them may cause
acute or chronic toxicity (poisoning).
Some well-known toxic metallic elements with a specific gravity that is 5 or more times
that of water are Arsenic, 5.7; Cadmium, 8.65;Iron, 7.9;Lead, 11.34; and Mercury, 13.546 (Lide
1992).2
Articles ( JAMA, Dec.15, 2004, Vol.292, No.23) published in some journals have
mentioned about the toxicity, presence of heavy metal contents of certain Ayurvedic Classical/
Proprietary preparations which is creating misconceptions among scientific communities and general
public regarding the safety of Ayurvedic/Siddha Rasa Kalpas and Bhasmas.
References
1. RasaRatna Samuchchaya,chapter 28/1.
2. http://www.lef.org/protocols/: Heavy Metal Toxicity
3. Rasa Ratna Samuchchaya,chapter 5/11,20,30,147.
1011
The classics of Ayurvedic Rasashastra and siddha system have specified different methods
of preparation and operational procedures since from the collection of raw drugs their purification,
processing, method of use, dosage forms etc. The raw drugs and finished products, if not
processed and preserved as per the classical literature specified, they may lead to improper
finished product with contaminants and may lead to toxic symptoms3. Thus this project is
undertaken to assess the heavy metal toxicity in patients receiving Ayurvedic /siddha preparations.
II. OBJECTIVE:
Observe the clinical/biochemical changes in subjects receiving Rasa Manikya Rasa, an
Ayurvedic Herbomineral / Metallic preparations for ensuring Clinical safety.
III. CENTRE:
Type of Study : Open
Level of Study : OPD
Period of Treatment : 15 days
Period of Study : 6 months
Details of treatment schedule
a) Drug: Rasa Manikya Rasa
b) Indicated conditions: Skin disorders, Dermatitis, Eczema etc.
c) Dosage schedule and duration: 60 mg BD for 15 days
d) Combinations with the main drug if any: Rasa Manikya Rasa 60 mg. in 2 gms. of
Chopachini Churna.
e) Anupana [Vehicle]: Lukewarm water
V. CRITERIA FOR INCLUSION:
1. Patients above 20 years and below 60 years of age.
2. Biochemical investigations for heavy metals at 0 day of assessment within the range.
3. Clinically diagnosed cases of Skin disorders, Dermatitis, Eczema etc.
1012
VI. CRITERIA FOR EXCLUSION:
1. Serum metallic levels of any of the metals exceeding permissible range at day 0 of
assessment
2. Age below 20 years & above 60 years
3. Known renal or Hepatic Pathology (Confirm by Clinical/Biochemical parameters)
4. Chronic Industrial Exposure
5. Patient receiving any other mineral preparation other than trial drug.
6. Major neuro-Psychiatric abnormalities
7. Chronic Smokers/Tobacco consumers
Screening of the patient as per case record form - I. The full details of history and
physical examination of the subjects will be recorded as per case report forms (Case report form
II). Clinical and physiological assessment (Case report form -III) and laboratory investigations
(Case report form -IV) will be done before treatment, at 0 day, 7th & 15thdays.
tabulated and analyzed using appropriate statistical tools. The data generated at the Institute on the
trial drug will have to be communicated to the Statistical Officer of CCRAS from time to time
through e-mail.
X. CRITERIA FOR ASSESSMENT OF OUTCOME OF STUDY
The assessment of progress & outcome of the study are assessed on the basis of clinical
and biochemical investigations.
The Statistical Section, CCRAS, Hqrs, New Delhi will undertake the monitoring of
progress of the trial and data analysis.
1013
XII. ETHICAL REVIEW
XIII. TRAVELLING EXPENSES
A consolidated amount of Rs.100/- per visit 0 day, 7th & 15thdays (Total Rs.300/-) will
be paid to the patient at the end of the study.
1014
the patient.
Date: _______________ Signature of the Investigator: ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the trial
and the nature of drug treatment and follow-up, including the laboratory investigations to be
in the clinical trial on “Open Observational Study on Clinical Safety of Selected (Rasa
Manikya Rasa) Ayurvedic and Siddha Herbomineral and Metallic Preparations.”
Relationship ___________________________________
1015

couple of decades; Ayurveda & Siddha recognizes their use long before that. The Ayurvedic
Rasashastra, one among the subspecialties of Ayurvedic & Siddha Pharmaceuticals has specified
therapeutic use of metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs
required in lesser doses, causes no distaste unlike herbal drugs and faster in action, these practices
became popular and widely accepted and safely used since long.
The Ayurvedic preparation identified for the study, Rasa Manikya Rasa is being frequently
prescribed by the practitioners since time immemorial for various common ailments encountered in
the general practice and found safe and effective.
However, considering the eco-climatic changes traces of certain unwanted substances may
instructions scrupulously. The study will take approximately 15 days to complete. During this
period, you are expected to visit the hospital 3 times (0, 7th & 15th days) for clinical, bio-chemical
1016
BEFORE TREATMENT
(Enter a () in the appropriate box)
1. Centre: ………………..……….
6. Address Permanent postal address with phone number & email if any.
..............................................................................................................................
..............................................................................................................................
1. Age above 20 & below 60 years
2. Biochemical investigations for heavy metals at

0 day of assessment within the range.
3. Clinically diagnosed cases of Skin disorders,

Dermatitis, Eczema etc.
EXCLUSION CRITERIA Yes (1) No (0)
4. Serum metallic levels of any of the metals

exceeding permissible range at day 0 of assessment
5. Age below 20 & Above 60 years
6. Known Renal or Hepatic Pathology
1017
8. Patient receiving any other mineral

preparation other than trial drug.
9. Major Neuro- Psychiatric abnormalities
10. Chronic Smokers / Tobacco Consumers.
A patient is eligible for admission to the trial,only if sl. No.1 - 3 are “yes” & if the sl.
No. 4-10 are “no”.
Date:___________________ Signature of Investigator:__________________
1018
1. Centre: ………………..……….
7. Address Permanent postal address with phone nu,ber & email if any.
8. Educational status: Illiterate 1 Literate 2 Matriculation 3
Graduate 4 PG 5
9. Annual Income Rs.
Less than Rs. 60,000/- (1) More than Rs. 60,000/- (2)
10. Occupation:
A. Current occupation related to significant exposure of dust, chemical, smoke or

heavy metal.
Yes If yes, details
No __________
B. Previous Occupation: [in last 3 years]
Was there any significant exposure to dust, chemicals smoke or heavy metal
Yes If yes, details
1019
No __________
a. H/o of intake of any Ayurvedic medicine yes-1 No-2

for the past 3 months
b. Disease/Cause for which therapy was taken —————————————————
c. Name of the Drug 1. —————————————————————
(Including brand name, 2. —————————————————————
Pharmacy, Batch no. & 3. —————————————————————
Dosage) 4. —————————————————————
5. —————————————————————
d. Date of starting the treatment: ——————————————————————
e. Duration of treatment ——————————————————————
f. Date of termination of therapy: ——————————————————————
g. Reason for termination of Therapy: ————————————————————
h. Cured / Dropped Out etc. ———————————————————————
12. History of Past illness:
Yes-1 No-2
If yes, details…………………………………………….....................................................
2. Previous episode
4. Treatment given so far
1020
13. Personal History:
Diet Veg (1) Non-veg. (2)
Sleep Satisfactory: (1) Unsatisfactory (2)
Constipation Yes (1) No (2)
History of Environmental tobacco
Smoking exposure Yes No Duration
Tobacco chewing
Betel chewing
Prakriti
Vata-kaphaj 4 Vata-pittaj 5 Pitta-kaphaj 6
Sama 7
14. HISTORY OF PRESENT ILLNESS:
Chief complaints & Duration
15. DIAGNOSIS:
OTHER SPECIFIC SYMPTOMS IF ANY WITH DURATION (0, 7th & 15thday)
Present-1 Absent-2 If present then

duration in months
1. Burning in throat (As,Hg)
2. Cough (Hg)
3. Difficulty in Swallowing (As)
4. Nausea (As, Cd, Hg, Pb)
5. Vomitting (As, Cd, Hg, Pb)
6. Excessive Salivation (Cd)
1021
7. Thirst (Pb)
8. Yellowing of teeth (Cd)
9. Diarrhea (As,Cd, Hg, Pb)
10. Abdominal Pain(As,Cd,Hg, Pb)
11. Garlic odor in the breath (As)
12. Metallic taste in mouth (Hg, Pb)
13. Difficulty in breathing (As, Cd, Hg)
14. Chest Pain (Cd)
15. Tightness/Burning in Chest(Hg)
16. Oliguria/Anuria (As,Pb)
17. Headache (As,Hg)
18. Irritability (As)
19. Muscular Weakness (As,Hg,Pb)
20. Convulsions (As)
21. Loss of Appetite-Anorexia

(Pb, As, Hg)
22. Fever (As,Cd)
23. Loss of Taste (Cd)
24. Loss of Smell (Cd)
25. Pain in joints (Cd, Pb)
26. Visual Disturbances (Hg)
27. Forgetfulness (Hg)
28. Lack of Concentration (Pb)
29. Anxiety (Hg)
1022
30. Emotional instability/Mood swings
(Hg, Pb)
31. Insomnia (Hg)
32. Weight Loss (Pb)
33. Shaky hands (Pb)
34. Numbness (Pb)
35. Vertigo (Pb)
36. Hallucinations (Pb)
37. Loss of consciousness
Note. Similar Signs/symptoms appearing as result of disease process /previous treatment

should be noted separately to avoid misinterpretation.
16. PHYSICAL EXAMINATION
Height (cm) ________________
Weight (kg) ________________
{ Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
Pulse rate (per min) ________________
Respiration rate (per min) ________________
Blood Pressure (mm Hg) ________________
Systolic ________________
Diastolic ________________
Body temperature ( o F) ________________
1023
Absent(0) Present (1)
Pallor
Lymphadenopathy
Cyanosis (As)
Clubbing nails
Edema
If present, specify
Bluish line on Gingiva

(lead line)
Skin & nails
Erythroderma (As)
Hyperkeratosis (As)
Hyperpigmentation (As)
Exfoliative Dermatitis (As)
Aldrich Mees Lines (As)

(Transverse white striae on fingernails)
17. SYSTEMIC EXAMINATION Normal (0) Abnormal (1)
CVS
CNS
Respiratory system
1024
Digestive system
Urogenital system
Date:_______________ Signature of investigator:_________________
1025
CASE REPORT FORM III – CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 7th & 15th day)
1. Centre: ………………..……….
7. Contact no. (Permanent postal address and phone number)
..............................................................................................................................
Email ID ..............................................................................................................
9. Name of Formulation ...........................................................................................................
I. ASSESSMENT OF THE TREATING CONDITION (The investigator should record the

progress of the treating condition viz. Improvement, adverse effects etc.)
II. OTHER SPECIFIC SYMPTOMS WITH DURATION (IF ANY)
Present-1 Absent-2 Duration
2. Cough (Hg)
1026
7. Thirst (Pb)
10. Abdominal Pain(As,Cd,Hg, Pb)
12. Metallic taste in mouth (Hg,Pb)
13. Difficulty in breathing (As,Cd,Hg )
14. Chest Pain (Cd)
15. Tightness/Burning in Chest (Hg)
21. Loss of Appetite-Anorexia (Pb,As,Hg)
22. Fever (As,Cd)
1027
29. Anxiety (Hg)
30. Emotional instability/Mood swings (Hg, Pb)
31. Insomnia (Hg)
34. Numbness (Pb)
35. Vertigo (Pb)
III. PHYSICAL EXAMINATION
1. Height (cm) ________________
2. Weight (kg) ________________
3.
{
Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
4. Pulse (per min) ________________
5. Respiration rate (per min) ________________
6. Blood Pressure (mm Hg) ________________
7. Systolic ________________
8. Diastolic ________________
9. Body temperature ( o F) ________________
10. Pallor
11. Lymphadenopathy
12. Cyanosis (As)
1028
13. Clubbing nails
14. Edema
If present, specify General Local

(Area) _________________
15. Bluish line on Gingiva

(lead line)
Skin & nails
16. Erythroderma (As)
17. Hyperkeratosis (As)
18. Hyperpigmentation (As)
19. Exfoliative Dermatitis (As)
20. Aldrich Mees Lines (As)

IV. SYSTEMIC EXAMINATION Normal (0) Abnormal (1)
CVS
CNS
Respiratory system
Digestive system
Urogenital system
*Note: Separate sheet of this form should be used for separate visits i.e 3 sheets for
3 visits.
1029
(0, 7th & 15thday)
1. Centre: ………………..……….
Urine Examination
8. Routine____________ Microscopic___________
9. Urinary levels of heavy Metals As ___________
Pb___________
Cd___________
Hg___________
Haematological Investigations
10. Serum Analysis for heavy Metals: As ___________
Pb ___________
Cd ___________
Hg ___________
1030
11. Hb (g/dl) _______________________________
12. TLC (Cells/Cu.mm.) ______________________
DLC
13. P (%) __________________
14. L(%) __________________
15. M (%) __________________
16. E(%) __________________
17. B (%) __________________
18. ESR (1st hour.) (mm) __________________
Blood Sugar
19. Fasting (mg./dl) __________________
20. Uric acid (mg./dl) __________________
Kidney function tests (Sl.No.)
21. B.Urea (mg./dl) __________________
22. S.Creatinine (mg./dl) __________________
Liver function tests (Sl.No.)
23. Total proteins (g./dl) __________________
24. Albumin (g. /dl) __________________
25. Globulin (g. /dl) __________________
26. A/G Ratio __________________
27. S.Bilirubin(mg./dL)
a. Total __________________
b. Direct __________________
1031
c. Indirect __________________
d. SGPT. (IU/L) __________________
e. SGOT (IU/L) __________________
28. Alk. Phosphates (KA units) __________________
29. X-ray chest (PA View) _____________________________________________
30. USG Whole Abdomen _____________________________________________
_____________________________________________
31. ECG (0,12 WEEK& if symptoms suggest sos) _________________________________
Date:______________ Signature of the Research Fellow/Investigator _______________
Place:_____________
Note:
• Investigations from Sl. No. 26-28 are to be done at 0 & 15thday.
*Note: Separate sheet of this form should be used for separate visits i.e. 3sheets for 3
visits.
1032
ANNEXURE-I
HEAVY METAL TOXICITY-GENERAL CONSIDERATIONS

Heavy metals become toxic when they are not metabolized by the body and accumulate
in the soft tissues. Exposure to toxic heavy metals is generally classified as acute, 14 days or less;
intermediate, 15-354 days; and chronic, more than 365 days (The Agency for Toxic Substances
and Disease Registry –ATSDR). Additionally, acute toxicity is usually from a sudden or
unexpected exposure to a high level of the heavy metal (e.g., from careless handling, inadequate
safety precautions, or an accidental spill or release of toxic material often in a laboratory,
industrial, or transportation setting). Chronic toxicity results from repeated or continuous exposure,
leading to an accumulation of the toxic substance in the body. Chronic exposure may result from
contaminated food, air, water, or dust; living near a hazardous waste site; spending time in areas
with deteriorating lead paint; maternal transfer in the womb; or from participating in hobbies that
use lead paint or solder. Chronic exposure may occur in either the home or workplace. Symptoms
of chronic toxicity are often similar to many common conditions and may not be readily
recognized. Routes of exposure include inhalation, skin or eye contact, and ingestion (ATSDR
MMGs and ToxFAQs; Anon. 1993; WHO 1998; International Occupational Safety and
Health Information Centre 1999; Roberts 1999; Dupler 2001; Ferner 2001).
Reference Range of some Toxic heavy Metals*
S.No. Name of Ref. Range in blood Ref. Range in Medical test

the mental (whole Blood) urine for Screening
1. Arsenic Arsenic (blood): Reporting Arsenic, Urine: Urine (best),
(As) Limit: 10ng/ml 0.0-52.7 ug/l hair, Finger
Reference Range: Up to 10 ng/ Arsenic, Urine (24 nails
ml hour) 0.0-63.9 ug/
Physiologic arsenic concentrations d
in unexposed individuals are Arsenic per gram
usually less than 10 ng/ml; creatinine < 35 ug/
however, the total arsenic g CRT
concentration may be markedly
increased after dietary
consumption of seafood.
2. Lead Lead (blood): Reporting Limit: Lead, Urine 0-23 Blood, Urine
1.0 ug/dl ug/L Hair
Normal (unexposed population): Lead, Urine (24-
1033
Children and adults < 10 ug/dl hour) 0 - 31 ug/d
Exposed: Children (0-6 years) Lead per gm of
> 10 ug/dl Creatinine
Adults (occupational exposure) No reference
OSHA action level 40ug/dl interval (ug/g CRT)
BEI (Biological Exposure 30
ug/dl
Index) (sampling time not
critical)
BAT (Biological Tolerance 70
ug/dl
Value) (sampling time not
critical)
Toxic: Children (0-6 years) >
70 ug/dl
Adults > 80 ug/dl
3. Cadmium 0.0 - 5.0 mcg/L Cadmium, Urine Urine (24 hr.)
0.0-2.6 ug/L CBC
Cadmium, Urine Hair Fingernail
(24-hour) 0.0-3.3
ug/d
Cadmium per
gram of creatinine
0.0-3.0 ug/g crt
4. Mercury Mercury (blood): (Mercury Mercury, Urine = Urine (24hr.)
measured as total mercury 0-10 ug/L Scalp hair
(inorganic, organic, and metallic). Mercury, Urine
Reporting Limit: 5 ng/ml (24-Hour) = 0-15
Reference Range: Up to 15 ng/ ug/d
ml Mercury per gram
Normal (unexposed population): of creatinine = No
less than 8 ng/ml reference interval
Exposed: (ug/g CRT)
BEI (Biological Exposure
Index): 15 ng/ml (total
inorganic) (end of shift, end of
workweek)
1034
BAT (Biological Tolerance
Value) 50 ng/ml (metallic and
inorganic)
Value): 100 ng/ml (organic)
References
1. Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
2. http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html
1035
ANNEXURE-II
LEAD
Lead is number 2 on the ATSDR’s “Top 20 List.”
Source: Every year, industry produces about 2.5 million tons of lead throughout the world. Most
of this lead is used for batteries. The remainder is used for cable coverings, plumbing, ammunition,
and fuel additives. Other uses are as paint pigments and in PVC plastics, x-ray shielding, crystal
glass production, pencils, and pesticides.
The inorganic forms of lead are absorbed through ingestion or inhalation, whereas organic lead salts
are absorbed through the skin. Only about 10% of an ingested dose is absorbed in adults, but the
absorbed percentage may be much greater in children. Lead absorption is enhanced by
deficiencies of iron, calcium, and zinc.
Targeted organs: Bones, Brain, Blood, kidneys, and thyroid gland (International Occupational
Safety and Health Information Centre 1999; ATSDR ToxFAQs for Lead).
Half Life: Some authorities list the half-life of lead in the bone as long as 30 years, while others
estimate the lead half-life in bone to be 105 days. Generally, excretion of lead is slow, with an
estimated biologic half-life in soft tissues of 24-40 days. The remainder of the stored lead is found
in soft tissue, notably the kidney and brain.
Excretion: The primary route of excretion is through feces (80-90%). To a lesser extent, lead is
excreted in urine (10%). Lead passes the placental barrier and is found in breast milk.
Clinical Features – A patient with lead poisoning may have a combination of symptoms - or no
symptoms at all until the condition has progressed.
Acute Poisoning
Alimentary System - Thirst
Metallic taste in mouth
Nausea
Colic (Abdominal pain)
Diarrhoea
Loss of appetite (Anorexia)
CNS Parasthesia (numbness) Hallucination
Muscle pain Vertigo
Fatigue Lethargy
Convulsions Ataxia
1036
Slurred speech Sleeplessness
Loss of consciousness
CVS Hypotension / Hypertension
Circulatory collapse
Blood Pallor (Severe Anemia – acute hemolytic crisis)
Renal System Oliguria
Chronic Poisoning
Births defects Shaky hand Numbness
Mental Retardation Muscular weakness lack of concentration
Autism Paralysis (Beginning in fore arms) Psychosis
Allergies Arthritis Colic
Dyslexia Hyper activity Weight loss
Mood swings Nausea
Leadline in gingival
Seizures
Chronic subclinical exposure to lead is associated
Interstitial nephritis,
Tubular damage
Hyperuricaemia
Oliguria (decline in GFR)
Chronic Renal Failure.
Blood lead levels in the range of 0.34 – 1.7 μmol/lit are associated with
• Increase in blood Pressure
• Decrease in creatinine clearance
• Decrements in cognitive performance
Laboratory Investigation -
1. Blood Test
(i) Blood Lead levels (N) blood level of lead < 1.9 μmol/L (40 μg/dl)
In children > 10 mcg/dl;
In Adults > 40 μ/dl are considered to be of concern
1037
(ii) Complete Blood Count (CBC) – (Normochromic, Normocytic anemia with
Basophilic stipplings on red cells in lead poisoning)
(iii) Serum Creatinine level (Elevated in chronic lead poisoning)
2. Long bone X-ray (in Children) (May reveal bands that indicate the failure of the bone to
rebuild)
3. Measurement of lead in teeth
4. Levels of lead in Urine [ Random urine < 150 μg/g creatinine (Not provoked with a
chelator) ]
5. Levels of lead in Faeces
6. Nerve Conduction Time (To know nerve induced peripheral demyelination)
7. Bone Lead Levels- k- ray-Flourescence
1038
ARSENIC
ANNEXURE-III
Arsenic is the most common cause of acute heavy metal poisoning in adults and is number
1 on the ATSDR’s “Top 20 List.
Sources: Sources of arsenic include
• Pesticides
• Herbicides
• Fungicides
• Wood preservatives
• Ceramic enamels
• Paints
• Tobacco (There may be as much as 6 micrograms per pack)
• Burning of Fossil fuels as arsenic is a contaminant
Occupational exposure can occur in
• The Smelting Industry (arsenic is a by –product of ores containing lead,gold,zinc,cobalt and
nickel)
• The microelectronics Industry
• Coal Power Plants
• Jobs involving the manufacturing of glass and fireworks
• Jobs with contact with pesticides
• Jobs with contact with wood treated with arsenic as a preservative
Absorption – Absorbed through skin, lungs and GIT
Targeted Organ: Target organs are the blood, kidneys, and central nervous, digestive, and skin
systems.
After absorption of inorganic arsenic, the compound accumulates in the liver, spleen,
kidneys, lungs and gastrointestinal tract. It is then rapidly cleared from these tissues but it leaves
a residue in Keratin rich tissues such as skin, hair and nails.
Metabolism Inorganic compounds are absorbed more readily than organic 80% of this is
ingested through GIT.
Blood 24 hour liver, kidney, lung and spleen
2 weeks skin, hair & bone.
1039
Inorganic salts in - leukocytes
(x) (does not cross crosses placenta.

Blood brain barrier)
Excretion – 90 – 95% in Urine
5 – 10% in excreta
Small amounts are recovered in bile, feces & saliva,
After an overdose, arsenic may be detected in urine up to 7-21 days.
Lethal dose - 130-300 mg.
Toxicity - Acute toxicity of arsenic is associated with
GIT - Burning in throat
Difficulty in swallowing
Nausea
Vomiting
Diarrhoea
Abdominal Pain
Garlic odor in the breath.
CVS - Difficulty in breathing
Hypotension
Cyanosis
CNS - Delirium
Coma
Seizures
Urinary system- Acute Tubular Necrosis
Hemoglobinuria,/ Hematuria
Hematological System - Haemolysis
Eosinophilia
Bone Marrow Depression.
Chronic - 2-8 weeks following ingestion
Skin & Nails - Erythroderma
1040
Hyperkeratosis
Hyperpigmentation
Exfoliative Dermatitis
Aldrich Mees lines (Transverse white striae on the fingernails)
Mucous Membrane
• Laryngitis
• Tracheitis
• Bronchitis
CNS • Polyneuritis (sensory & Motor)
• Basal cell carcinomas
• Squamous cell carcinomas
Other effects • Capillary injury
Necrosis of stomach, small bowel, vascular & degenerative changes in liver
& kidney
Laboratory Investigations-
Arsenic levels can be measured in blood, urine, hair and fingernails. Urine tests are most reliable
1. X-ray abdomen - (As is radio opaque and is seen on x-ray of abdomen).
2. ECG- (QRS complex broadening, QT prolongation, ST segment depression, T wave
flattening & multifocal ventricular tachycardia)
3. LFT (abnormal)
4. Hb (anaemia)
5. Leukopenia/ Leukocytosis
6. Protein urea
7. Hematuria
8. Cellular casts in the urine
9. Urine Arsenic levels (normally less than 67 nmol 5 μg/d)
10. May also be detected in hairs & nails for months following exposure.
1041
ANNEXURE-IV
CADMIUM
Cadmium is a byproduct of the mining and smelting of lead and zinc and is number 7 on
ATSDR’s “Top 20 list.”
(Absorbed Cd is mostly concentrated in liver and kidneys)
Sources – Cadmium has a wide variety of sources in the environment and from industry. One
source is from ingestion of grown foodstuffs, especially grain and leafy vegetables, which readily
absorb cadmium from the soil. The cadmium may occur naturally or as a contaminant and the
contaminants include sewage, sludge fertilizers, polluted ground water and mining effluents.
Cadmium is also a constituent of alloys, pigments, batteries, metal coatings for example protective
coating on steel, plastics and fertilizers. Occupational exposure may occur from the manufacture of
these products and from welding, and smelting of lead, zinc and copper as these occur in mixed
ores with cadmium. Cadmium is also found in Cigarette fumes and fumes from vehicles.
Absorption: Inhalation accounts for 15-50% of absorption through the respiratory system; 2-7%
of ingested cadmium is absorbed in the gastrointestinal system.
Target organs - Target organs are the liver, placenta, kidneys, lungs, brain, and bones (Roberts
1999; ATSDR ToxFAQs for Cadmium).
Clinical Toxicology – (4-24 h)
Acute - High dose Cd inhalation can cause severe respiratory irritation.
Pleuritic chest pain
Dysponea
Cyanosis
Fever
Tachycardia
Nauses
Pulmonary edema (non cardiogenic)
COPD
Renal Disease
Fragile bones
Emphysema
1042
Through Ingestion (Acute)
Nauses
Vomiting
Salivation
Abdominal cramps
Diarrhoea
Chronic
Anosmia - Alopecia
Yellowing of the teeth - Anaemia
Emphysema - arthritis
Minor changes in the liver function - learning disorders
Micorocytic hypochronic anemia
(unresponsive to iron therapy) - migraines
Renal tubular dysfunction
(Proteinuria & increased excretion of B2 microglobulin) - growth impairment
Osteomalacia (bone lesions & Pseudofractures)
Osteoporosis, loss of taste & smell poor appetite
Lab. Findings.
1. Blood level of CD >500nmol/L (5 μg/dl) is considered toxic)
2. urinary conc of B2 microglobulin.
24 hour urine. Specimen → Creatinine level in urine
CBC Hair & Fingernail clippings)
(Creatinine level in unine above 10 mg/dl) suggest Cadmium toxicity.
1043
ANNEXURE-V
MERCURY
Mercury is number 3 on ATSDR’s “Top 20 List”. It is generated naturally in the environment from
the degassing of the earth’s crust, from volcanic emissions. It exists in three forms: elemental
mercury and organic and inorganic mercury.
Sources : Mining operations, chloralkali plants, and paper industries are significant producers of
mercury (Goyer 1996).Mercury continues to be used in thermometers, thermostats, and dental
amalgam. (Many researchers suspect dental amalgam as being a possible source of mercury
toxicity [Omura et al. 1996; O’Brien 2001].) Medicines, such as mercurochrome and
merthiolate, are still available. Algaecides and childhood vaccines are also potential sources. People
who consume more than two fish meals a week are showing very high serum levels of mercury.
Absorption: Inhalation is the most frequent cause of exposure to mercury. The organic form is
readily absorbed in the gastrointestinal tract (90-100%); lesser but still significant amounts of
inorganic mercury are absorbed in the gastrointestinal tract (7-15%). Target organs are the brain
and kidneys (Roberts 1999; ATSDR ToxFAQs for Mercury).
Target Organs: Target organs are the brain and kidneys (Roberts 1999; ATSDR ToxFAQs for
Mercury).
Symptoms:
Symptoms of acute exposure are
• Cough
• Sore throat
• Shortness of breath
• Metallic taste in the mouth
• Abdominal pain
• Nausea,
• Vomiting
• Diarrhoea
• Headache
• Weakness
• Visual disturbances
• Tachycardia
• Hypertension.
1044
Chronic exposure to mercury may result in
• Permanent damage to the central nervous system (Ewan et al. 1996) and kidneys.
• Tremors
• Anxiety
• Forgetfulness
• Emotional instability
• Insomnia
• Fatigue
• Weakness
• Anorexia
• Loss of Cognitive functions
• Mercury can also cross the placenta from the mother to the fetus (levels in the fetus are
often double those in the mother) and accumulate, resulting in mental retardation, brain
damage, cerebral palsy, blindness, seizures, and inability to speak
Laboratory Investigations:
• Blood and urine samples are used to determine recent exposure, as well as exposure to
elemental mercury and inorganic forms of mercury.
• Blood mercury levels should not exceed 50 mcg/L (see the ATSDR Medical
Management Guidelines).
• A 24-hour urine specimen is collected for measurement of mercury levels.
• Chest x-rays can reveal a collection of mercury from exposure to elemental mercury or
a pulmonary embolism containing mercury (Ferner 2001).
• Abdominal x-rays can reveal swallowed mercury as it moves through the gastrointestinal
tract.
• Scalp hair is used in testing for exposure to methylmercury.
• Liver and kidney function tests are also important in severely exposed persons.
References
Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
MetalsasToxins:http://www.portfolio.mvm.ed.ac.uk/studentwebs/session2/group29/introtox.htm
http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html http://www.lef.org/protocols/prtcl-
072.shtml#mostimpblt
1045
Blank
1046
OPEN OBSERVATIONAL STUDY ON CLINICAL
SAFETY OF SELECTED AYURVEDIC AND SIDDHA
Drug: Study Code:

AND SIDDHA
1047
Blank
1048
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
I. BACKGROUND
couple of decades; Ayurveda recognizes their use long before that. Rasashastra, one among the
subspecialties of Ayurvedic Pharmaceuticals and Siddha classics have specified therapeutic use of
metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs required in lesser
doses, causes no distaste unlike herbal drugs and faster in action, these practices became popular
and widely accepted and safely used since long.1
Heavy metals are chemical elements with a specific gravity that is at least 5 times the
specific gravity of water. There are 35 metals that concern us because of occupational or
residential exposure; 23 of these are the heavy elements or “heavy metals”: antimony, arsenic,
bismuth, cadmium, cerium, chromium, cobalt, copper, gallium, gold, iron, lead, manganese, mercury,
nickel, platinum, silver, tellurium, thallium, tin, uranium, vanadium, and zinc (Glanze 1996).
Interestingly, small amounts of these elements are common in our environment and diet and are
actually necessary for good health, but inappropriate dosage forms of any of them may cause
acute or chronic toxicity (poisoning).
Some well-known toxic metallic elements with a specific gravity that is 5 or more times
that of water are Arsenic, 5.7; Cadmium, 8.65; Iron, 7.9; Lead, 11.34; and Mercury, 13.546
(Lide 1992).2
Articles ( JAMA, Dec.15, 2004, Vol.292, No.23) published in some journals have
mentioned about the toxicity, presence of heavy metal contents of certain Ayurvedic Classical/
Proprietary preparations which is creating misconceptions among scientific communities and general
public regarding the safety of Ayurvedic/Siddha Rasa Kalpas and Bhasmas.
References
1. RasaRatna Samuchchaya, chapter 28/1.
2. http://www.lef.org/protocols/: Heavy Metal Toxicity
3. RasaRatna Samuchchaya, chapter 5/11,20,30,147.
1049
The classics of Ayurvedic Rasashastra and siddha system have specified different
methods of preparation and operational procedures since from the collection of raw drugs their
purification, processing, method of use, dosage forms etc. The raw drugs and finished products, if
not processed and preserved as per the classical literature specified, they may lead to improper
finished product with contaminants and may lead to toxic symptoms3. Thus this project is
undertaken to assess the heavy metal toxicity in patients receiving Ayurvedic /siddha preparations.
II. OBJECTIVES:
Observe the clinical/biochemical changes in subjects receiving Vasanta Kusumakara Rasa
- an Ayurvedic Herbomineral / Metallic preparations for ensuring Clinical safety
III. CENTRE: Identified CCRAS Institutes.
IV. SOURCE OF PROCUREMENT OF TRIAL DRUGS:
The selected Ayurvedic & Siddha drugs will be procured from IMPCL and IMPCOPS,
Chennai. The requisite quantities of all the drugs will be procured and supplied to the identified
Institutes and CSMDRIA, Chennai by Central Research Institute (Ay) New Delhi [from IMPCL],
Central Research Institute (Siddha), Chennai [from IMPCOPS]. The physico-chemical standards
will be evolved by Cpt. Srinivasa Murthy Drug Research Institute for Ayurveda, Chennai.
V. SAMPLE SIZE AND METHODS: - 15 subjects
TYPE OF STUDY : Open
LEVEL OF STUDY : OPD
PERIOD OF TREATMENT : 30 days
PERIOD OF STUDY : 6 months
DRUG & Details of treatment schedule
a) Drug- Vasanta Kusumakara Rasa
b) Diagnosis - Prameha, Dourbalya
c) Dosage schedule and duration - 60 mg BD for 30 days
d) Combinations with the main drug: Vasanta Kusumakara Rasa 60 mg. in 3 gms. of
Ashwagandha Churna.
e) Anupana [Vehicle]: Water.
VI. CRITERIA FOR INCLUSION:
1. Patients above 20 years and below 60 years of age.
2. Biochemical investigations for heavy metals at 0 day of assessment within the range.
1050
3. Clinically diagnosed cases of Prameha & Dourbalya
VII. CRITERIA FOR EXCLUSION:
1. Serum metallic levels of any of the metals exceeding permissible range at day 0 of
assessment
2. Age below 20 years & above 60 years
3. Known renal or Hepatic Pathology (Confirm by Clinical/Biochemical parameters)
5. Patient receiving any other mineral preparation other than trial drug.
6. Major neuro-Psychiatric abnormalities
7. Chronic Smokers/Tobacco consumers
VIII. CRITERIA FOR WITHDRAWAL:
Screening of the patients will be recorded as per case record form-I. The full details of
history and physical examination of the subjects will be recorded as per case record forms (Case
record form II). Clinical and physiological assessment (Case record form -III) and laboratory
investigations (Case report form -IV3) will be done before treatment, at 0, 15th & 30th days.
tabulated and analyzed using appropriate statistical tools. The data generated at the Institute on the
selected trial drug will have to be communicated to the Statistical Officer of CCRAS from time to
time through e-mail.
XI. CRITERIA FOR ASSESSMENT OF OUTCOME OF STUDY
The assessment of progress & outcome of the study are assessed on the basis of clinical
and biochemical investigations.
XII. TRIAL MONITORING AND DATA ANALYSES
The Statistical Section, CCRAS, Hqrs, New Delhi will undertake the monitoring of
progress of the trial and data analysis.
1051
Institutional Ethical Committee (IEC) of participating Center’s shall issue clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form shall
be submitted along with project proposal for approval by IEC and maintained in duplicate with one
copy given to the patient at the time of entry to the trial.
XIV. TRAVELLING EXPENSES
A consolidated amount of Rs.100/- per visit (Total Rs.300/-) will be paid to the patient at
the end of the study.
XV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
personnel involved in this open observational trial at CCRAS Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial conduct
XVI. LABORATORY INVESTIGATIONS
XVII. FINANCIAL APPROVAL:
The financial implications as required for different purposes will be met from sanctioned
budget of the Institute concerned under the head Research Activities (Plan). All the procedures
should be executed following the codal formalities with necessary approvals of the Council.
1052
the patient.
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the trial
and the nature of drug treatment and follow-up, including the laboratory investigations to be
in the clinical trial on “Open Observational Study on Clinical Safety of Selected (Vasanta
Kusumakara Rasa) Ayurvedic / Siddha Herbomineral and Metallic Preparations.”
Relationship ___________________________________
1053
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL
AND METALLIC PREPARATIONS.

couple of decades; Ayurveda & Siddha recognizes their use long before that. The Ayurvedic
Rasashastra, one among the subspecialties of Ayurvedic & Siddha Pharmaceuticals has specified
therapeutic use of metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs
required in lesser doses, causes no distaste unlike herbal drugs and faster in action, these practices
became popular and widely accepted and safely used since long.
The Ayurvedic preparation- Vasantha kusumakara ras, identified for the observational study
is being frequently prescribed by the practitioners since time immemorial for various common
ailments encountered in the general practice and found safe and effective.
However, considering the eco- climatic changes traces of certain unwanted substances may
period, you are expected to visit the hospital 3 times (0, 15th & 30th days) for clinical,
biochemical and physiological assessment.
physical examination, required objective tests and laboratory investigations will also be done. If you
are found eligible, you would be put on treatment for 1 month.
1054
HERBOMINERAL AND METALLIC PREPARATIONS.
BEFORE TREATMENT
(Enter a () in the appropriate box)
1. Centre: ………………..……….
6. Address Permanent postal address with phone number & email if any.
..............................................................................................................................
..............................................................................................................................
1. Age above 20 & below 60 years
2. Biochemical investigations for heavy metals at

0 day of assessment within the range.
3. Clinically diagnosed cases of Prameha & Dourbalya
EXCLUSION CRITERIA Yes (1) No (0)
4. Serum metallic levels of any of the metals

Exceeding permissible range at day 0 of assessment
5. Age below 20 & Above 60 years
6. Known Renal or Hepatic Pathology
1055
8. Patient receiving any other mineral

preparation other than trial drug.
9. Major neuro- Psychiatric abnormalities
10. Chronic Smokers / Tobacco Consumers.
A patient is eligible for admission to the trial, only if sl. No.1 - 3 are “yes” & if the sl.
No. 4-10 are “no”.
Date:___________________ Signature of Doctor:______________________
1056
1. Centre: ………………..……….
7. Address Permanent postal address with phone nu,ber & email if any.
8. Educational status: Illiterate 1 Literate 2 Matriculation 3
Graduate 4 PG 5
9. Annual Income Rs.
Less than Rs. 60,000/- (1) More than Rs. 60,000/- (2)
10. Occupation:
A. Current occupation related to significant exposure of dust, chemical, smoke or

heavy metal.
Yes If yes, details
No __________
B. Previous Occupation: [in last 3 years]
Was there any significant exposure to dust, chemicals smoke or heavy metal
Yes If yes, details
1057
No __________
a. H/o of intake of any Ayurvedic medicine yes-1 No-2

for the past 3 months
b. Disease/Cause for which therapy was taken —————————————————
c. Name of the Drug 1. —————————————————————
(Including brand name, 2. —————————————————————
Pharmacy, Batch no. & 3. —————————————————————
Dosage) 4. —————————————————————
5. —————————————————————
d. Date of starting the treatment: ——————————————————————
e. Duration of treatment ——————————————————————
f. Date of termination of therapy: ——————————————————————
g. Reason for termination of Therapy: ————————————————————
h. Cured / Dropped Out etc. ———————————————————————
12. History of Past illness:
Yes-1 No-2
If yes, details…………………………………………….....................................................
2. Previous episode
4. Treatment given so far
1058
13. Personal History:
Diet Veg (1) Non-veg. (2)
Sleep Satisfactory: (1) Unsatisfactory (2)
Constipation Yes (1) No (2)
History of Environmental tobacco
Smoking exposure Yes No Duration
Tobacco chewing
Betel chewing
History of alcohol intake
Occasional (1) Regular (2)
Prakriti
Vata-kaphaj 4 Vata-pittaj 5 Pitta-kaphaj 6
Sama 7
Chief complaints & Duration
DIAGNOSIS:
OTHER SPECIFIC SYMPTOMS IF ANY WITH DURATION (0, 15th & 30thday)
Present-1 Absent-2 If present then

duration in months
2. Cough (Hg)
1059
7. Thirst (Pb)
10. Abdominal Pain (As,Cd,Hg, Pb)
12. Metallic taste in mouth (Hg, Pb)
13. Difficulty in breathing (As, Cd, Hg)
14. Chest Pain (Cd)
21. Loss of Appetite-Anorexia

(Pb, As, Hg)
22. Fever (As,Cd)
1060
29. Anxiety (Hg)
30. Emotional instability/Mood swings

(Hg, Pb)
31. Insomnia (Hg)
34. Numbness (Pb)
35. Vertigo (Pb)
Note. Similar Signs/symptoms appearing as result of disease process /previous treatment

should be noted separately to avoid misinterpretation.
Height (cm) ________________
Weight (kg) ________________
{ Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
Pulse (per min) ________________
Respiration rate (per min) ________________
Blood Pressure (mm Hg) ________________
Systolic ________________
Diastolic ________________
Body temperature ( o F) ________________
1061
Pallor
Lymphadenopathy
Cyanosis (As)
Clubbing nails
Edema
If present, specify General (1) Local (2)
Area __________________________________________________________________
Bluish line on Gingiva

(lead line)
Skin & nails
Erythroderma (As)
Hyperkeratosis (As)
Hyperpigmentation (As)
Exfoliative Dermatitis (As)
Aldrich Mees Lines (As)

CVS
CNS
Respiratory system
1062
Digestive system
Urogenital system
1063
CASE REPORT FORM III– CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 15th, 30thday)
1. Centre: ………………..……….
7. Contact no. (Permanent postal address and phone number)
..............................................................................................................................
Email ID ..............................................................................................................
9. Name of Formulation ...........................................................................................................
ASSESSMENT OF THE TREATING CONDITION (The investigator should record the

progress of the treating condition viz. Improvement, adverse effects etc.)
OTHER SPECIFIC SYMPTOMS WITH DURATION (IF ANY)
Present-1 Absent-2 Duration
2. Cough (Hg)
1064
7. Thirst (Pb)
10. Abdominal Pain (As,Cd,Hg, Pb)
12. Metallic taste in mouth (Hg,Pb)
13. Difficulty in breathing (As,Cd,Hg )
14. Chest Pain (Cd)
21. Loss of Appetite-Anorexia (Pb,As,Hg)
22. Fever (As,Cd)
1065
29. Anxiety (Hg)
30. Emotional instability/Mood swings (Hg, Pb)
31. Insomnia (Hg)
34. Numbness (Pb)
35. Vertigo (Pb)
38. Height (cm) ________________
39. Weight (kg) ________________
{
Weight (kg.)
40. B.M.I. ———————
Height (meters)2 } ________________
41. Pulse (per min) ________________
42. Respiration rate (per min) ________________
43. Blood Pressure (mm Hg) ________________
44. Systolic ________________
45. Diastolic ________________
46. Body temperature ( o F) ________________
47. Pallor
48. Lymphadenopathy
1066
49. Cyanosis (As)
50. Clubbing nails
51. Edema
If present, specify General Local

(Area) _________________
52. Bluish line on Gingiva

(lead line)
Skin & nails
53. Erythroderma (As)
54. Hyperkeratosis (As)
55. Hyperpigmentation (As)
56. Exfoliative Dermatitis (As)
57. Aldrich Mees Lines (As)

CVS
CNS
Respiratory system
Digestive system
1067
(0, 15th, 30th days)
1. Centre: ………………..……….
Urine Examination
8. Routine____________ Microscopic___________
9. Urinary levels of heavy Metals As ___________
Pb___________
Cd___________
Hg___________
Haematological Investigations
10. Serum Analysis for heavy Metals: As ___________
Pb ___________
Cd ___________
Hg ___________
1068
11. Hb (g/dl) _______________________________
12. TLC (Cells/Cu.mm.) ______________________
DLC
13. P (%) __________________
14. L(%) __________________
15. M (%) __________________
16. E(%) __________________
17. B (%) __________________
18. ESR (1st hour.) (mm) __________________
Blood Sugar
19. Fasting (mg./dl) __________________
20. Uric acid (mg./dl) __________________
Kidney function tests (Sl.No.)
21. B.Urea (mg./dl) __________________
22. S.Creatinine (mg./dl) __________________
Liver function tests (Sl.No.)
23. Total proteins (g./dl) __________________
24. Albumin (g. /dl) __________________
25. Globulin (g. /dl) __________________
26. A/G Ratio __________________
27. S.Bilirubin(mg./dL)
a. Total __________________
b. Direct __________________
1069
c. Indirect __________________
d. SGPT. (IU/L) __________________
e. SGOT (IU/L) __________________
28. Alk. Phosphates (KA units) __________________
29. X-ray chest (PA View) _____________________________________________
30. USG Whole Abdomen _____________________________________________
_____________________________________________
31. ECG (0,12 WEEK& if symptoms suggest sos) _________________________________
Date:______________ Signature of the Research Fellow/Investigator _______________
Place:_____________
1070
ANNEXURE-I
HEAVY METAL TOXICITY-GENERAL CONSIDERATIONS

Heavy metals become toxic when they are not metabolized by the body and accumulate
in the soft tissues. Exposure to toxic heavy metals is generally classified as acute, 14 days or less;
intermediate, 15-354 days; and chronic, more than 365 days (The Agency for Toxic Substances
and Disease Registry –ATSDR). Additionally, acute toxicity is usually from a sudden or
unexpected exposure to a high level of the heavy metal (e.g., from careless handling, inadequate
safety precautions, or an accidental spill or release of toxic material often in a laboratory,
industrial, or transportation setting). Chronic toxicity results from repeated or continuous exposure,
leading to an accumulation of the toxic substance in the body. Chronic exposure may result from
contaminated food, air, water, or dust; living near a hazardous waste site; spending time in areas
with deteriorating lead paint; maternal transfer in the womb; or from participating in hobbies that
use lead paint or solder. Chronic exposure may occur in either the home or workplace. Symptoms
of chronic toxicity are often similar to many common conditions and may not be readily
recognized. Routes of exposure include inhalation, skin or eye contact, and ingestion (ATSDR
MMGs and ToxFAQs; Anon. 1993; WHO 1998; International Occupational Safety and
Health Information Centre 1999; Roberts 1999; Dupler 2001; Ferner 2001).
Reference Range of some Toxic heavy Metals*
S.No. Name of Ref. Range in blood Ref. Range in Medical test

the mental (whole Blood) urine for Screening
1. Arsenic Arsenic (blood): Reporting Arsenic, Urine: Urine (best),
(As) Limit: 10ng/ml 0.0-52.7 ug/l hair, Finger
Reference Range: Up to 10 ng/ Arsenic, Urine (24 nails
ml hour) 0.0-63.9 ug/
Physiologic arsenic concentrations d
in unexposed individuals are Arsenic per gram
usually less than 10 ng/ml; creatinine < 35 ug/
however, the total arsenic g CRT
concentration may be markedly
increased after dietary
consumption of seafood.
2. Lead Lead (blood): Reporting Limit: Lead, Urine 0-23 Blood, Urine
1.0 ug/dl ug/L Hair
Normal (unexposed population): Lead, Urine (24-
1071
Children and adults < 10 ug/dl hour) 0 - 31 ug/d
Exposed: Children (0-6 years) Lead per gm of
> 10 ug/dl Creatinine
Adults (occupational exposure) No reference
OSHA action level 40ug/dl interval (ug/g CRT)
BEI (Biological Exposure 30
ug/dl
Index) (sampling time not
critical)
BAT (Biological Tolerance 70
ug/dl
Value) (sampling time not
critical)
Toxic: Children (0-6 years) >
70 ug/dl
Adults > 80 ug/dl
3. Cadmium 0.0 - 5.0 mcg/L Cadmium, Urine Urine (24 hr.)
0.0-2.6 ug/L CBC
Cadmium, Urine Hair Fingernail
(24-hour) 0.0-3.3
ug/d
Cadmium per
gram of creatinine
0.0-3.0 ug/g crt
4. Mercury Mercury (blood): (Mercury Mercury, Urine = Urine (24hr.)
measured as total mercury 0-10 ug/L Scalp hair
(inorganic, organic, and metallic). Mercury, Urine
Reporting Limit: 5 ng/ml (24-Hour) = 0-15
Reference Range: Up to 15 ng/ ug/d
ml Mercury per gram
Normal (unexposed population): of creatinine = No
less than 8 ng/ml reference interval
Exposed: (ug/g CRT)
BEI (Biological Exposure
Index): 15 ng/ml (total
inorganic) (end of shift, end of
workweek)
1072
Value) 50 ng/ml (metallic and
inorganic)
Value): 100 ng/ml (organic)
References
1. Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
2. http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html
1073
ANNEXURE-II
LEAD
Lead is number 2 on the ATSDR’s “Top 20 List.”
Source: Every year, industry produces about 2.5 million tons of lead throughout the world. Most
of this lead is used for batteries. The remainder is used for cable coverings, plumbing, ammunition,
and fuel additives. Other uses are as paint pigments and in PVC plastics, x-ray shielding, crystal
glass production, pencils, and pesticides.
The inorganic forms of lead are absorbed through ingestion or inhalation, whereas organic lead salts
are absorbed through the skin. Only about 10% of an ingested dose is absorbed in adults, but the
absorbed percentage may be much greater in children. Lead absorption is enhanced by
deficiencies of iron, calcium, and zinc.
Targeted organs: Bones, Brain, Blood, kidneys, and thyroid gland (International Occupational
Safety and Health Information Centre 1999; ATSDR ToxFAQs for Lead).
Half Life: Some authorities list the half-life of lead in the bone as long as 30 years, while others
estimate the lead half-life in bone to be 105 days. Generally, excretion of lead is slow, with an
estimated biologic half-life in soft tissues of 24-40 days. The remainder of the stored lead is found
in soft tissue, notably the kidney and brain.
Excretion: The primary route of excretion is through feces (80-90%). To a lesser extent, lead is
excreted in urine (10%). Lead passes the placental barrier and is found in breast milk.
Clinical Features – A patient with lead poisoning may have a combination of symptoms - or no
symptoms at all until the condition has progressed.
Acute Poisoning
Alimentary System - Thirst
Metallic taste in mouth
Nausea
Colic (Abdominal pain)
Diarrhoea
Loss of appetite (Anorexia)
CNS Parasthesia (numbness) Hallucination
Muscle pain Vertigo
Fatigue Lethargy
Convulsions Ataxia
1074
Slurred speech Sleeplessness
Loss of consciousness
CVS Hypotension / Hypertension
Circulatory collapse
Blood Pallor (Severe Anemia – acute hemolytic crisis)
Renal System Oliguria
Chronic Poisoning
Births defects Shaky hand Numbness
Mental Retardation Muscular weakness lack of concentration
Autism Paralysis (Beginning in fore arms) Psychosis
Allergies Arthritis Colic
Dyslexia Hyper activity Weight loss
Mood swings Nausea
Leadline in gingival
Seizures
Chronic subclinical exposure to lead is associated
Interstitial nephritis,
Tubular damage
Hyperuricaemia
Oliguria (decline in GFR)
Chronic Renal Failure.
Blood lead levels in the range of 0.34 – 1.7 μmol/lit are associated with
• Increase in blood Pressure
• Decrease in creatinine clearance
• Decrements in cognitive performance
Laboratory Investigation -
1. Blood Test
(i) Blood Lead levels (N) blood level of lead < 1.9 μmol/L (40 μg/dl)
In children > 10 mcg/dl;
In Adults > 40 μ/dl are considered to be of concern
1075
(ii) Complete Blood Count (CBC) – (Normochromic, Normocytic anemia with
Basophilic stipplings on red cells in lead poisoning)
(iii) Serum Creatinine level (Elevated in chronic lead poisoning)
2. Long bone X-ray (in Children) (May reveal bands that indicate the failure of the bone to
rebuild)
3. Measurement of lead in teeth
4. Levels of lead in Urine [ Random urine < 150 μg/g creatinine (Not provoked with a
chelator) ]
5. Levels of lead in Faeces
6. Nerve Conduction Time (To know nerve induced peripheral demyelination)
7. Bone Lead Levels- k- ray-Flourescence
1076
ARSENIC
ANNEXURE-III
Arsenic is the most common cause of acute heavy metal poisoning in adults and is number
1 on the ATSDR’s “Top 20 List.
Sources: Sources of arsenic include
• Pesticides
• Herbicides
• Fungicides
• Wood preservatives
• Ceramic enamels
• Paints
• Tobacco (There may be as much as 6 micrograms per pack)
• Burning of Fossil fuels as arsenic is a contaminant
Occupational exposure can occur in
• The Smelting Industry (arsenic is a by –product of ores containing lead,gold,zinc,cobalt and
nickel)
• The microelectronics Industry
• Coal Power Plants
• Jobs involving the manufacturing of glass and fireworks
• Jobs with contact with pesticides
• Jobs with contact with wood treated with arsenic as a preservative
Absorption – Absorbed through skin, lungs and GIT
Targeted Organ: Target organs are the blood, kidneys, and central nervous, digestive, and skin
systems.
After absorption of inorganic arsenic, the compound accumulates in the liver, spleen,
kidneys, lungs and gastrointestinal tract. It is then rapidly cleared from these tissues but it leaves
a residue in Keratin rich tissues such as skin, hair and nails.
Metabolism Inorganic compounds are absorbed more readily than organic 80% of this is
ingested through GIT.
Blood 24 hour liver, kidney, lung and spleen
2 weeks skin, hair & bone.
1077
Inorganic salts in - leukocytes
(x) (does not cross crosses placenta.

Blood brain barrier)
Excretion – 90 – 95% in Urine
5 – 10% in excreta
Small amounts are recovered in bile, feces & saliva,
After an overdose, arsenic may be detected in urine up to 7-21 days.
Lethal dose - 130-300 mg.
Toxicity - Acute toxicity of arsenic is associated with
GIT - Burning in throat
Difficulty in swallowing
Nausea
Vomiting
Diarrhoea
Abdominal Pain
Garlic odor in the breath.
CVS - Difficulty in breathing
Hypotension
Cyanosis
CNS - Delirium
Coma
Seizures
Urinary system- Acute Tubular Necrosis
Hemoglobinuria,/ Hematuria
Hematological System - Haemolysis
Eosinophilia
Bone Marrow Depression.
Chronic - 2-8 weeks following ingestion
Skin & Nails - Erythroderma
1078
Hyperkeratosis
Hyperpigmentation
Exfoliative Dermatitis
Aldrich Mees lines (Transverse white striae on the fingernails)
Mucous Membrane
• Laryngitis
• Tracheitis
• Bronchitis
CNS • Polyneuritis (sensory & Motor)
• Basal cell carcinomas
• Squamous cell carcinomas
Other effects • Capillary injury
Necrosis of stomach, small bowel, vascular & degenerative changes in liver
& kidney
Laboratory Investigations-
Arsenic levels can be measured in blood, urine, hair and fingernails. Urine tests are most reliable
1. X-ray abdomen - (As is radio opaque and is seen on x-ray of abdomen).
2. ECG- (QRS complex broadening, QT prolongation, ST segment depression, T wave
flattening & multifocal ventricular tachycardia)
3. LFT (abnormal)
4. Hb (anaemia)
5. Leukopenia/ Leukocytosis
6. Protein urea
7. Hematuria
8. Cellular casts in the urine
9. Urine Arsenic levels (normally less than 67 nmol 5 μg/d)
10. May also be detected in hairs & nails for months following exposure.
1079
ANNEXURE-IV
CADMIUM
Cadmium is a byproduct of the mining and smelting of lead and zinc and is number 7 on
ATSDR’s “Top 20 list.”
(Absorbed Cd is mostly concentrated in liver and kidneys)
Sources – Cadmium has a wide variety of sources in the environment and from industry. One
source is from ingestion of grown foodstuffs, especially grain and leafy vegetables, which readily
absorb cadmium from the soil. The cadmium may occur naturally or as a contaminant and the
contaminants include sewage, sludge fertilizers, polluted ground water and mining effluents.
Cadmium is also a constituent of alloys, pigments, batteries, metal coatings for example protective
coating on steel, plastics and fertilizers. Occupational exposure may occur from the manufacture of
these products and from welding, and smelting of lead, zinc and copper as these occur in mixed
ores with cadmium. Cadmium is also found in Cigarette fumes and fumes from vehicles.
Absorption: Inhalation accounts for 15-50% of absorption through the respiratory system; 2-7%
of ingested cadmium is absorbed in the gastrointestinal system.
Target organs - Target organs are the liver, placenta, kidneys, lungs, brain, and bones (Roberts
1999; ATSDR ToxFAQs for Cadmium).
Clinical Toxicology – (4-24 h)
Acute - High dose Cd inhalation can cause severe respiratory irritation.
Pleuritic chest pain
Dysponea
Cyanosis
Fever
Tachycardia
Nauses
Pulmonary edema (non cardiogenic)
COPD
Renal Disease
Fragile bones
Emphysema
1080
Through Ingestion (Acute)
Nauses
Vomiting
Salivation
Abdominal cramps
Diarrhoea
Chronic
Anosmia - Alopecia
Yellowing of the teeth - Anaemia
Emphysema - arthritis
Minor changes in the liver function - learning disorders
Micorocytic hypochronic anemia
(unresponsive to iron therapy) - migraines
Renal tubular dysfunction
(Proteinuria & increased excretion of B2 microglobulin) - growth impairment
Osteomalacia (bone lesions & Pseudofractures)
Osteoporosis, Loss of taste & smell. Poor appetite
Lab. Findings.
1. Blood level of CD >500nmol/L (5 μg/dl) is considered toxic)
2. urinary conc of B2 microglobulin.
24 hour urine. Specimen → Creatinine level in urine
CBC Hair & Fingernail clippings)
(Creatinine level in unine above 10 mg/dl) suggest Cadmium toxicity.
1081
ANNEXURE-V
MERCURY
Mercury is number 3 on ATSDR’s “Top 20 List”. It is generated naturally in the environment from
the degassing of the earth’s crust, from volcanic emissions. It exists in three forms: elemental
mercury and organic and inorganic mercury.
Sources : Mining operations, chloralkali plants, and paper industries are significant producers of
mercury (Goyer 1996).Mercury continues to be used in thermometers, thermostats, and dental
amalgam. (Many researchers suspect dental amalgam as being a possible source of mercury
toxicity [Omura et al. 1996; O’Brien 2001].) Medicines, such as mercurochrome and
merthiolate, are still available. Algaecides and childhood vaccines are also potential sources. People
who consume more than two fish meals a week are showing very high serum levels of mercury.
Absorption: Inhalation is the most frequent cause of exposure to mercury. The organic form is
readily absorbed in the gastrointestinal tract (90-100%); lesser but still significant amounts of
inorganic mercury are absorbed in the gastrointestinal tract (7-15%). Target organs are the brain
and kidneys (Roberts 1999; ATSDR ToxFAQs for Mercury).
Target Organs: Target organs are the brain and kidneys (Roberts 1999; ATSDR ToxFAQs for
Mercury).
Symptoms:
Symptoms of acute exposure are
• Cough
• Sore throat
• Shortness of breath
• Metallic taste in the mouth
• Abdominal pain
• Nausea,
• Vomiting
• Diarrhoea
• Headache
• Weakness
• Visual disturbances
• Tachycardia
• Hypertension.
1082
Chronic exposure to mercury may result in
• Permanent damage to the central nervous system (Ewan et al. 1996) and kidneys.
• Tremors
• Anxiety
• Forgetfulness
• Emotional instability
• Insomnia
• Fatigue
• Weakness
• Anorexia
• Loss of Cognitive functions
• Mercury can also cross the placenta from the mother to the fetus (levels in the fetus are
often double those in the mother) and accumulate, resulting in mental retardation, brain
damage, cerebral palsy, blindness, seizures, and inability to speak
Laboratory Investigations:
• Blood and urine samples are used to determine recent exposure, as well as exposure to
elemental mercury and inorganic forms of mercury.
• Blood mercury levels should not exceed 50 mcg/L (see the ATSDR Medical
Management Guidelines).
• A 24-hour urine specimen is collected for measurement of mercury levels.
• Chest x-rays can reveal a collection of mercury from exposure to elemental mercury or
a pulmonary embolism containing mercury (Ferner 2001).
• Abdominal x-rays can reveal swallowed mercury as it moves through the gastrointestinal
tract.
• Scalp hair is used in testing for exposure to methylmercury.
• Liver and kidney function tests are also important in severely exposed persons.
1083
Blank
1084
SECTION-XIX
ANNEXURE
Blank
1086
Annexure-I
CASE REPORT FORM FOR DETERMINATION OF PRAKRUTI /
UDALIYAL/MIZAJ
1. PHYSIOLOGICAL STATUS (PHS)

1.01 Status of Appetite: (AD)
a. Good appetite
b. Stable appetite with usually moderate desire to eat
c. Variable appetite
1.02 Dietary/Eating habits (DH)
a. Enjoys eating, ready to eat mostly & hates to miss food
b. Regular food habits, but can spend hours without food
c. Desirous to take food, eats less at a time, needs mid-meals
snacks
1.03 Bowel Habits (BH)
a. Regular, once-a-day, stool well formed, if constipated it is mild
(Respond to medium strength laxative)
b. Regular & frequent, stool semisolid or loose, rarely constipated.
(Respond to mild laxatives sometimes even milk, fig., raisins etc.)
c. Variation seen, mostly constipated (strong purgatives are needed)
1.04 Sleeping Pattern (SH)
a. Sleeps easily but light
b. Sleeps easily and sound (heavily)
c. Trouble to get sleep, light sleep / Variable sleep pattern
1.05 Morning feelings, after leaving the bed (MF)
a. Don’t feel fresh
1087
b. Feel fresh. Feel well even with less sleep.
c. Feel fresh but not good when have less hours of sleep.
1.06 Dreams (DM)
a. Cool and peaceful dreams, not bothers to remember
b. Passionate dreams, sees heat, light & remembers well
c. Plenty of dreams, mostly related to motion, usually forgets
1.07 Physical working capacity/physical strength
a. Starts with speed & gets exhausted easily
b. Loves hard work, has moderate capacity
c. Good stamina but slow and not interested for physical work.
1.08 Performance of activities
a. Quickly with a lot of initiative
b. Moderately with medium initiative
c. Slow, steady and balance activities
1.09 Talking
a. Very fast missing words
b. Sharp, provocative and clear-cut
c. Slow, clear and stable
1.10 Walking
a. Very quick with swift movement
b. Normal and rhythm
c. Slow and steady
1.11 Associated movements of body while working
a. Excessive and frequent, difficult to tolerate
b. Less thirst, easy to tolerate
c. Moderate perspiration, consistent to climate, with pleasant smell.
1088
1.12 Nature of Thirst (TN)
a. Excessive and frequent, difficult to tolerate
b. Less thirst, easy to tolerate
c. Moderate and variable thirst
1.13 Status of Perspiration (SP)
a. Scanty even in hot climate but odourless
b. Profuse with strong odour
c. Moderate perspiration, consistent to climate, with pleasant smell.
1.14 Sexual qualities (SQ)
a. Variable, strong desire, overindulgence, & gets exhausted
b. Moderate with domina ting behavior
c. Usually low and steady desire, with good stamina
1.15 Quantity of seminal discharge
a. Scanty and comparatively thin in consistency
b. Moderate and normal
c. Plenty and thick
1.16 Fertility or productivity
a. Comparatively lesser
b. Less
c. Capable of producing good no. of off springs
1.17 Longevity or average age
a. Short life span
b. Moderate life span
c. Long life span
1.18 Resistance to diseases (RD)
a. Usually poor. Frequently fall ill.
b. Medium
1089
c. Good. Able to tolerate seasonal variation, food etc. well
1.19 Climatic Preferences (CP)
a. Prefers warm, avoids cold climate
b. Likes cold, but intolerant to warm/hot
c. Likes normal climate & prefers warm in comparison to cold
2. MENTAL/PSYCHOLOGICAL STATUS:
2.01 Mental Reactions (MR)/Personality Traits:
a. Very sensitive, reacts quickly
b. Gets Irritated easily & sustains it.
c. Cool, calm, avoids confrontations
2.02 Memory Status (MS)
a. Remembers easily & tends to forget easily
b. Takes time to grasp, but retains for long
c. Remembers easily and tends to retain
2.03 Leadership quality (LQ)
a. Don’t like to lead and happy as a follower.
b. Requires commanding status.
c. Avoid leading.
2.04 Decision making capacity(DMC)
a. Takes immediate decision without thinking much.
b. Takes decision after properly analyzing the facts.
c. Avoid taking decision. Usually keeps them pending.
2.05 Concentration Power (CP)
a. Very easy to concentrate on a work, but not for long duration
b. Difficult to concentrate on a work
c. Retains concentration for a long period
1090
2.06 Attitude towards problems or difficulties
Lot of worrying, instability in reaction
Angry, over awed, easily provoked and highly irritable
Peaceful, slow, steady and balance
2.07 Nature
a. Easily irritable, irritating to others, exaggerating, anxious materialistic liking
b. Polite but hot-tempered, proudy, brave, bold, less but good friendship
c. Polite, decent, not greedy, appreciating, have good and long lasting friendship
2.08 Liking about taste (TL)
a. Sweet, salt & sour
b. Sweet, bitter & astringent
c. Pungent, astringent & bitter
3. PHYSICAL FEATURES: (PF)
3.01 Body frame (BF)
a. Thin body frame, unusually long/short
b. Medium frame
c. Broad, Large frame
3.02 Body weight (BW)
a. Moderate/Average weight
b. Underweight or Tendency of fluctuation
c. Over weight or with a tendency to gain weight
3.03 Distribution of body fat (DBF)
a. Unequal/on specific areas
b. Evenly distribution
c. Scanty deposition of body fat.
3.04 Nature/Texture of skin
a. Delicate, Irritable skin, gets wrinkles easily
1091
b. Dry, rough, cracked, or having a tendency of cracking
c. Smooth, firm, soft, clear with good lusture, not prone to disorders
3.05 Complexion/skin color (SC)
a. Extremely fair / pinkish
b. Fair, reddish, burns easily
c. Comparatively dull or darkish, tans easily
3.06 Body Hair (BH)
a. Dry, rough, coarse, lustureless & curly
b. Soft, scanty, straight, fine textured
c. Thick, shiny, moderate
3.07 Forehead (FH)
a. Large
b. Medium
c. Small
3.08 Eyes (EF)
a. Rolling, restless, small, dull & lusterless
b. Sharp, medium sized with sclera of reddish tinge
c. Large calm stable eyes with milky white sclera
3.09 Teeth (TE)
a. Teeth are of average size, yellowish, prone to cavities
b. Dry, cracked, irregular dull white
c. Large, even, gleaming white
3.10 Tongue (TO)
a. Thin tongue, with blackish spots, often coated with thin adherent coating
b. Medium, Reddish, occasionally coated with yellow or red coating
c. Thick usually clear, rarely coated, coating is usually thick white
1092
3.11 Lips (LP)
a. Soft, moist & reddish
b. Dry, thin & blackish
c. Thick & glossy
3.12 Blood Vessels (BV)
a. Prominent
b. Less prominent
c. Not visible
3.13 Scalp Hair (SH)
a. Dark in Shade, coarse, rough, easily prone to dandruff and split ends.
b. Thin, delicate, straight, light coloured, turn grey at an early age
c. Strong, thick, dark, slightly wavy with good lusture, oiliness is usually
one of the chief complaints
3.14 Joints (JT)
a. Crackling joints, hyper mobile in nature
b. Comparatively normal but have soft and loose ligaments
c. Well lubricated, strongly built joints which are well organized, well covered
3.15 Voice (VR)
a. Rough, unclear voice, which turns hoarse or cracks on strain
b. Concise, sharp voice, intense in nature & high pitched
c. Deep, pleasant, resonant voice which is melodious, resonating,
but lower in pitch and intensity
3.16 Nail (NL)
a. Hard, brittle, rough & differ in size from one another, bluish/grayish in
contour
b. Soft, Strong, well formed, Lustrous, pink in colour
c. Strong, large, thick symmetrical & somewhat pale in colour
1093
3.17 Body temperature
a. Feels slightly cold on touch
b. Feels slightly warm on touch
c. Normal
3.18 Shape of Palms and feet
a. Short and broad
b. Medium and slim
c. Long and broad
3.19 Face
a. Small and broad with uneven features
b. Medium & oval with sharply defined features
c. Round, babbly and attractive with balance features
4 Social or economical status
4.01 Economy
a. Getting less outcome with hard work
b. Getting good outcome with moderate efforts
c. Enjoys lavishly and royal life
1094
SCORE SHEET FOR DETERMINATION OF PRAKRUTI /UDALIYAL /MIZAJ
Sl. no. of the subject_________________________________________________________
S.No. Observation Options Identified Area (V/P/K)

Code a b c
1. 1.01 P K V
2. 1.02 P K V
3. 1.03 K P V
4. 1.04 P K V
5. 1.05 V P K
6. 1.06 K P V
7. 1.07 V P K
8. 1.08 V P K
9. 1.09 V P K
10. 1.10 V P K
11. 1.11 V P K
12. 1.12 P K V
13. 1.13 V P K
14. 1.14 V P K
15. 1.15 V P K
16. 1.16 V P K
17. 1.17 V P K
18. 1.18 V P K
19. 1.19 V P K
20. 2.01 V P K
21. 2.02 V K P
22. 2.03 K P V
23. 2.04 V P K
24. 2.05 P V K
1095
25. 2.06 V P K
26. 2.07 V P K
27. 2.08 V P K
28. 3.01 V P K
29. 3.02 P V K
30. 3.03 K P V
31. 3.04 P V K
32. 3.05 K P V
33. 3.06 V P K
34. 3.07 K P V
35. 3.08 V P K
36. 3.09 P V K
37. 3.10 V P K
38. 3.11 P V K
39. 3.12 V P K
40. 3.13 V P K
41. 3.14 V P K
42. 3.15 V P K
43. 3.16 V P K
44. 3.17 V P K
45. 3.18 V P K
46. 3.19 V P K
47. 4.01 V P K
INDIVIDUAL SCORE OF VPK V P K
PERCENTAGE OF VPK V= P= K=
TYPE OF PRAKRITI /UDALIYAL/ MIZAJ
Abbreviations-V- Vata /Vali/Sauda, P- Pitta /Azhal/Safra, K- Kapha/ Iyam/Balgam
1096

Central Council For Research in Ayurveda and Sidd

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CLINICAL RESEARCH PROTOCOLS

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

Central Council for Research in Ayurveda and Siddha

© Central Council for Research in Ayurveda and Siddha, New Delhi

Note: Reproduction/Translation/Citation of any part of this publication are welcome with

Cover Page Designed by : Dr. N. Srikanth, Assistant Director (Ay.)

While designing the research trials it would be appropriate to understand differences

(Dr. C.D. Tripathi)

New Delhi (Prof. G.S. Lavekar)

Prof. G.S. LAVEKAR

Dr. C.D. TRIPATHI

Dr. M.M. PADHI

Dr. M.M. Rao Dr. Sulochana Bhat

All India Institute of Medical Sciences, New Delhi

Dr. M.V. Padma Prof. S.K. Sharma

Indian Council for Medical Research, New Delhi

Banaras Hindu University, Varanasi

Prof. R.G. Singh, Prof. Dr. Manjari Dwivedi

Prof. Ashok Shah Dr. S.C. Manchanda

Ayurvedic & Siddha Experts

Dr. S.K. Mishra Dr. B.V. Sathe

Dr. K.D. Sharma

Dr. Seema Jain, Dr. Syed Hissar,

Dr. Nikhil Jirankalgikar

Sl. No. Subject Page

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

To be translated into regional language.

What is the study about?

To be translated into regional language.

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 15 to 60 years

2. Both the sexes irrespective of caste/religion.

3. Uncomplicated cases of bronchitis.

4. Repeated attacks of bronchitis.

CRITERIA FOR EXCLUSION Yes (1) No (0)

5. Age below 15 years and above 60 years.

6. Cough associated with other respiratory disorders

7. Bronchial Asthma, Bronchiectasis, cases of tuberculosis,

8. Interstitial lung disease/occupational Lung disease, tropical

9. Pulmonary eosinophilia, Loffler s disease, Allergic

11. Severe renal/Hepatic disease

12. Pregnant/lactating mother

A patient is eligible for admission to the trial

If Sl.No.1-4 is ‘Yes’ and Sl.No.5-12 are ‘No’

If admitted, Sr. No. of the Subject: _________________________

Date: __________________ Signature of the investigator: ___________________

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Date:_ Name of witness: _____________________

Date: Signature of the investigator: _

Systolic _mm/Hg Diastolic _mm/Hg