STEP 1

 Hortus medicus : klinik tipe A.

 Saintifikasi : pembuktian jamu berdasarkan EBM pelayanan kesehatan.

STEP 2

1. Explain about purpose of scientification traditional herbal medicine ?

2. What scope of scientification traditional herbal medicine ?
3. What are steps (proces) of scientification traditional herbal medicine ?
4. What is difference between clinical trial and scientification traditional
herbal medicine ?
5. What are step of clinical trial ?
6. What is difference of A clinic and B clinic ?
7. What are the terms of scientification traditional herbal medicine ?
8. What are the regulation of scientification traditional herbal medicine ?
9. What are the purpose of clinical trial ?

STEP 3

1. Explain about purpose of scientification traditional herbal medicine ?

 Provide a scintification / evidence based emprical use of herbal
medicine through health servise-based research.
  Endourage the formation of networks of doctors or dentists ans
other health worked as researchers in the context of preventive,
promotive, rehabilitative, and paliative efforts through the use of
herbs
 Improve qualitative research activities for patients with the use of
herb.
 Incressing the supply of safe herbs, hes real properties that are
scientifically tested, and widely used both for self-medication in
health care facilities.
Source : permenkes RI nomor 003 tahun 2010 pasal 2 bab II about
scientifikasi herb medicine in research basic on health service
2. What the scope of scientification traditional herbal medicine ?
 To promotion, prevention, treat and rehabilitation
o Treatment : should be written or listen by pation only for
complementer and alternative medicine.

Source : permenkes RI nomor 003 tahun 2010 pasal 3 about

scientifikasi herb medicine in research basic on health service

3. What are steps (proces) of scientification traditional herbal medicine ?

 Frist step : etno farmacology  clinical trial konvensional
o Etno farmacology : to get bisedline data releated to use for
herbal medicine. Identification of herbs the part of herbs its
can make to treat the disease and indication of every herbs
to disease.
o Study etno medicine and ento farmacology  empiric
formula.
o Data empiric  evaluation benefit and safety just throgh
clinical trial fase 2 (design pre and post test study) and 3
(design RCT with blinding or without blinding).
o If it is without data empiric  new formula  evaluation
benefit and safety througt preclinical trial  tocxixity acute
trial, subcronic, and farmacodinamical trial in animals. 
clinical fase 1,2 and 3.
o Scientification with or without data empiric  comersial
product.
 o Before comersial product  we should check distribution in
BPOM.
 Second step : selection of herbal formulation has a potention for
alternative or complementer medicine.
 Third step : clinical trial  to get regret the benefit and safety.
Source :
- permenkes RI nomor 003 tahun 2010 about scientifikasi herbs
medicine in research basic on health service
- Expo unpad
4. What are the terms of scientification traditional herbal medicine ?
 Herbal medicine must requirment :
o Safe according spesific requirements
o Benefit is based on data empiric
o Spesific quality requirements

Source : permenkes RI nomor 003 tahun 2010 pasal 4 about

scientifikasi herb medicine in research basic on health service

5. What are the regulation of scientification traditional herbal medicine ?

 Permenkes RI no. 3 tahun 2010 about scientification traditional
herbal medicine service based research.
 Kepmenkes RI no. 121 tahun 2008 about standart herbal medical
service
 Kepmenkes no 1334/2010 about national scaintification herbal
commission.
Sejarah :
Tahun 1996  indonesia mengunakan jamu untuk pengobatan 
tidak diterima  tidak teruji. Muncul permenkes  jamu harus di
ubah ke fitofarmaka.
2004  jamu  fitofarmaka = 6 jamu  BPOM memisahkan jamu
3 bagian : jamu, OHT, dan fitifarmaka.
2010  permenkes mengaluarkan saintifikasi jamu dengan
manfaat dapat dipertanggung jawabkan.
Source : expo unpad
6. What is difference of A clinic and B clinic ?
 A Clinical : must have some condition like :
 o Employment like doctor, pharmacist asistens, administrator.
o Fasility or equipment of medic and herbal.
o Have Rooms : waiting room, registration room, daining
room, discusion room, herbal storage, simple labs, etc.
 B clinical :
o Have rooms : just have waiting room and registration room

Source : permenkes RI nomor 003 tahun 2010 pasal 8 about scientifikasi

herb medicine in research basic on health service.

7. What are the purpose of clinical trial ?

 To proof benefit of traditional medicine according the indication
of disease.
 To proof safety status of use the traditonal medicine to human.
 make a data to push research tradisonal herbal medicine.
 Clinical trial may compar a new medical approch to standart that
is already available to a placebo the contains no active ingrediance
or to know intervention
 The investigation try to determine the sefety and efficy of the
interventionby measuring certain outcam in the participant
 The ultimate goal of clinical research is to obtain a unbased
inferace with possible best precission in order to scien tifically
adress the clinical question regarding the study drug under
investigation with target respect population.
Source:
- permenkes RI nomor 003 tahun 2010 about scientifikasi herb
medicine in research basic on health service
- US National Liberary of medicine clinical trial.gov
- Design and analysis of clinical trial concepts and metodelogys
type 2.

8. What are step of clinical trial ?

 phase 1  ussually involves small grup of healthy people , to see
side effect and tollerants of the subject to the drug tested.
o Study participant : 20 -100 healty volunter people with the
disease or condition, between 20-50 people.
 o length of study several month.
 Purpose : safety and tollerants.
Approximal 70% of the drug move to the next phase.
 Phase 2  in patients , stages clinical trial or openly without
controll., Since the subject use limited. Result : limited
conclusion;obtain can’t yet be use is as evidance of usefull of the
drug clinical.
o Study participant : up to several hundred people with
disease or condition. To get the drug between 100-200
people.
o Length of study : several month to second year.
 Purpose 1 : to test the new drug in larger grup of
people to better measure the safety and side effect.
 Purpose 2 :To see if the drug has positive effect in
patients.
Approximal 33% of drug move to the next phase.
 phase 3  in patients,
o study participant : 300 -3000 volunters who have disease or
condition. That can be enter 500 people
o Length of study : 1 to 4 years.
 purpose 1 : to compare the effect of new drug with
the standart treatment.
 Purpose 2 :To finded out how well the drug work and
how long the effect last. Approximaly 25% -30 % drug
to the next phase.
 phase 4  study participant several thousand volunters who have
the disease or condition
 purpose 1 :to find out how well the drug works when
it is used more widedly
 purpose 2 :to finded out the long trem risk and
benefit.
 Purpose 3 :More about possible rare side effect.

Source :

- Jurnal : evaluation benefit and safety drug

 - understanding clinical trial
- FDA/ US food and drug administration www.FDA.gov
9. What is difference between clinical trial and scientification traditional
herbal medicine ?

Clinical trial Scientification tradisional herbal

medicine
preclinical trial must be done before The evidance is besed on healthy
clinical trial provider
Free market drug The prescription should be given by
doctor or dentist
Should be done with several test : Empiric data
toxicity test, pharmacodinamic test,
standarisation of sample.

Source : permenkes RI 003 tahun 2010 scientification in healthy service

based research.

10.What is principle of clinical trial ?

 There are empiric evidance
 There are pharmacological data
 It has been proven to be safe based on toxicological research and
has been stated to meet safety requirement for tesing in human.
 Selection :
o In the clinical trial may have criteria : patients
o Inclusion criteria :
 Diagnosis criteria
 Clinis sign
 Laboratoris criteria
 Grade of disease
 Age, gende, addres.
o Exclusion criteria :
 Pregnantion

Source :

Mapping :
 scientification
herbal
medicine

regulation criteria process

permenkes RI
no. 3 tahun safety based EBM preclinical trial clinical trial
2010

fase 1,2, and 3