Page 103 - journal-13-2-S-Full

94

Research and Evaluation of Traditional Medicineé which gives key advice on Study Designs other than Randomized
Controlled Trial or RCT, namely:
- Single-case design
- Black-box design
- Ethnographic design
- Observational design
- Etc.
Certainly, such study designs would give less reliable results than the results from RCT studies. However, at least,
these study designs allow researches on indigenous and traditional medicine to be carried out with certain level of
reliability.
One major problem of human research on indigenous and traditional medicine is if it is required that robust safety
data from preclinical studies, as same as in modern pharmaceutical products studies, must be submitted, it might not be
possible to further conduct clinical study. As herbal recipes used in these fields of medicine are usually composed of many
herbal ingredients, if in vitro and in vivo studies in animals on all compounds from all herbs are requested, it would require
huge investment such that R&D on herbal recipes cannot be done.
In order to comply with the principle that researches involving human subjects can be carried out only when there
is information to show that the test drug is safe enough and has potential efficacy to risk human lives in the clinical study,
the long history of use and the recorded documents on its use should be utilized as evidence for the consideration of its
safety.
As a result, the Committee for the Consideration of Human Research in the Field of Traditional and Alternative
Medicine of the Ministry of Public Health, Thailand therefore set key criteria to facilitate the conduct of clinical study in
these fields of medicine in Item 2.7 of the Committee guideline as follows:
çShould have adequate, convincing and qualified evidences of substantiate in safety based on previous history of
use, references or text books, animal experiment, or research papers.é
Conclusion
As stated in the item 16 of the Declaration of Helsinki 2013 that çIn medical practice and in medical research, most
interventions involve risks and burdens.é and item 5 that çMedical progress is based on research that ultimately must
include studies involving human subjectsé, indigenous medicine and traditional medicine also subject to research and
studies to prove the safety and the efficacy. And when research involving human subjects is needed, it is necessary to
follow international guidelines on research ethics. In order to make it possible to conduct research on indigenous and
traditional medicine, it is necessary to appropriately design the study and consider safety data so as to facilitate proper
conduct of research in these fields of medicine and promote ethical research.