1. How is the proces of scintification traditional herbal medicine?

http://www.gizikia.depkes.go.id/wp-content/uploads/downloads/2012/07/permenkes-003tahun2010.pdf
MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
NUMBER: 003 / Menkes / Per / I / 2010
ABOUT
Saintifikasi herbs IN RESEARCH-BASED
HEALTH SERVICES
Article 8
(1) Herbal Clinic consists of:
a. Herbal Clinic Type A
b. Herbal Clinic Type B
(2) A type of herbal medicine clinics must meet the following requirements:
a. Workforce that includes:
1) The doctor in charge
2) Assistant Pharmacist.
3) other alternative complementary health worker as needed.
4) Diploma (D3) traditional healers and / or traditional healers herb in the Association of
Traditional Healers who recognized the Ministry of Health.
5) Power Administration.
b. Means that includes:
1) Medical equipment
2) Equipment herbs
Having the room:
a) The waiting room.
b) Onsite registration and medical records (medical records).
c) Space consulting / implementation research.
d) the examination room / action.
e) Space herbal compounding.
f) Storage space herbs.
g) Space discussion.
h) simple laboratory space.
i) Space herbal pharmacy.
(3) Herbal Clinic Type B must meet the following requirements:
a. Workforce that includes:
1) The doctor in charge
2) Power _alternatif other complementary health as needed.
3) Diploma (D3) traditional healers and / or traditional healers herb in the Association of
Traditional Healers who recognized the Ministry of Health.
4) Power Administration.
b. Means that includes:
1) Medical equipment.
2) Equipment herbs.
3) Have the room:
a) The lounge and registration.
b) consulting room, examination / action / research and medical records (medical
records).
c) Space herbal compounding.

(4) Power traditional healers as referred to in paragraph (2) and (3) only a supporting
staff in service delivery herbs.
(5) Further provisions on Herbal Clinic guidelines stipulated by the Decree of the
Minister of Health.
part Three
workforce
Article 11
(1) The doctor or dentist and other health professionals who provide services in health
care facilities herbal medicine as referred to in Article 7 paragraph (2) shall have:
a. Registration Certificate (STR) of the Indonesian Medical Council for doctors or
dentists, pharmacists and STRA for license / registration of the Head of the Provincial
Health Office to other health professionals.
b. Having a practice license for a doctor or dentist and work permit / license for the
practice of other health personnel of the District Health Office / Municipality.
c. Have proof of the registration of complementary alternative medicine as power (SBRTPKA) from the Head of the Provincial Health Office.
d. Have a letter of assignment as an alternative complementary medicine personnel
(ST-TPKA / SIK-TPKA) of the Chief Medical Officer / City.
(2) The provisions referred to in paragraph (2) shall be implemented in accordance with
the provisions of the legislation in force.
Article 12
For the power of traditional healers should have registered letter / license as traditional
healers power in Health Service District / Municipality in accordance with the provisions
of the legislation in force.
part Four
approval Actions
Article 13
(1) The herbs are given to patients in order to research-based health care can only be
given after obtaining consent (informed consent) of the patients.
(2) The approval referred to in paragraph (1) is given after the patient explanations, and
given orally or in writing in accordance with the provisions of the legislation in force.
part Five
recording
Article 14
(1) Health workers and other personnel who conduct research based herbal medicine
services to patients should be taking notes in the medical record (medical records).
(2) The medical records referred to in paragraph (1) is made separately in accordance
with the guidelines of herbal medicine services at health facilities.
part Six
Ethical approval
Article 15
Implementation of research activities and etical clearance herbal research conducted in
accordance with the provisions of the legislation in force.
2. What is the different in clinical trial between convensional medicine and traditional
herbal medicine( fitofarmaca)

inatradmed.nihrd.or.id/.../2.1.2.%20Dr.%20Siswa...

3. How is te regulation of scientification traditional herbal medicine?

http://www.litbang.depkes.go.id/riset-jamu
In order to provide the scientific evidence related to the quality, safety, and the
benefits of traditional medicine (herbal medicine), the Government of Indonesia, in
this case the Ministry of Health, Ministry of Health has issued Regulation No.03 /
Menkes / PER / 2010 on Saintifikasi Herbs. Saintifikasi medicinal herbs is scientific
evidence through research-based service kesehatan.2 One aim is to provide the
scientific basis (evidenced based) through the use of herbs empirically-based
research services performed in health care facilities, in this case care clinic medicinal
/ herbal practitioner. To run Saintifikasi herbs in accordance with Regulation of the
Minister of Health No. 03 / Menkes / PER / 2010, then Minister of Health has been
set No.1334 of 2010 on the National Commission Saintifikasi Herb, whose job is to
develop guidelines for herbal research methodology.
In Permenkes No. 03 / Menkes / Per / 2010 on Sainti fi cation Herbal stated that one
of the objectives Sainti Herbal fi cation is to provide the scientific basis (evidencedbased) use of herbs empirically through research conducted in health-care facilities,
in this case the clinic
care herbal / medicinal practice physician. Inside the Permenkes. there is a chapter
that describes the goal setting sainti fi cation of herbs that Chapter II, Article 2 on
goal setting sainti fi cation of herbs as well as Chapter III of Part One of Article 4,
Chapter III of Part Two of Article 6, Article 7, Article 8, Chapter III of Part Three of
Workforce Article 11 and Chapter III of Part Five on Registration article 14. in the
chapters that have not been studied about the role of the pharmacist in sainti fi cation
herbs.
On the other hand, according to Law No. 36 of 2009 section 108 and Government
Regulation No. 51 of 2009 on the practice of pharmacy stating that the practice of
pharmacy includes the manufacture of pharmaceutical preparations including quality
control, security, procurement, storage and distribution of drugs, over prescription
drug services, drug information services as well as drug development, drug material
and traditional medicine must be performed by skilled health personnel who have the
expertise and authority in accordance with laws and regulations.
4. What is the rules : method, subject ,of clinical trial

5. What is the purpose of scientification traditional herbal medicine?

Saintifikasi medicinal herbs is scientific evidence through research-based health care.
Based on the Regulation of the Minister of Health, number 003 / Menkes / Per / I / 2010,
the purpose saintifikasi herbs are:
1. Provide the scientific basis (evidence based) use of herbs empirically through
research-based health care.
2. Encourage the establishment of network doctors or dentists and other health
professionals as researchers in an effort to preventive, promotive, rehabilitative, and
palliative care through the use of herbs.
3. Improve qualitative research on patients with the use of herbs.
4. Increase the supply of safe herbal medicine, has a real efficacy scientifically proven,
and widely used either for treatment or within health care facilities.
While the scope of herbal saintifikasi preferred to attempt preventive, promotive,
rehabilatif and palliative. Saintifikasi curative herbs in an effort can only be made upon
written request of the patient as a complementary-alternative after patients receive
adequate explanation.
Organizers saintifikasi herbs is public or private health facilities with health professionals
consisting of doctors, dentists, pharmacists, nurses, and other health personnel in
accordance with existing regulations.
http://www.litbang.depkes.go.id/klinik_jamu

6. The obstacle of clinical trial ?

Obstacles to Clinical Trials
There are many reasons to participate in a clinical trial; sometimes there are obstacles.
These obstacles can be overcome with education on your options and availability of
resources. Lack of communication between your doctor and you could cause you to be
excluded from participation in a clinical trial. The doctor may perceive a lack of interest
or there is not an appropriate trial available. In addition insurance may not pay the cost
of a trial.
A lack of information regarding patient rights, accessibility, and choices to not participate
can be an obstacle. A clinical trial may not be available locally requiring the patient to
consider a trial some distance from their home. The need to travel a distance to obtain
care creates an obstacle due to the inability to afford the cost of transportation to get to
the trial. Transportation resources are located in the Resource Appendix at the end of
this guide. Many hospitals or treatment facilities
offer assistance to help with theses costs. Some programs assist with lodging and meals
free of charge or provide affordable rates. Many hotels offer a medical rate that is more
affordable than the standard rate for lodging. Be sure to inquire at the treating facility for
a list of local resources.
Another huge obstacle for potential participants is a loss of income, not only due to their
illness, but sometimes their caregiver's loss of income. A spouse, child, or other
significant other may become a caregiver and need to stay with the patient to provide
support during the trial. This can be a challenge depending on the type of study and how
often the patient needs to be seen. The patient or caregiver has options available with
their employer. Discuss these options with your Human Resources Department
regarding Short Term Disability (STD) or Long Term Disability (LTD), Family Medical
Leave Act (FMLA), availability of sick pool donations, and/or altered work schedules. If
you will not be able to work for at least one year due to treatment and recovery they
should apply for Social Security Disability Income (SSDI) or Social Security Income
(SSI).
http://www.patientadvocate.org/index.php?p=681
7. What is the diffrent between clinical trial of fitofarmaca and scientification of traditional
herbal medicine
https://www.bpfk.gov.my/.../Mr%20Ruslan%20Fi...