Nuance of Clinical Trials in Traditional Medicine


• Professor and Director, Interdisciplinary School of Health Sciences, University of Pune
• Chief of Academics at Manipal Education
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Nuance of Clinical Trials in Traditional Medicine


7th INTRACOM – 2nd ICBWI 2009


25th July 2009

Place Held

PWTC, Kuala Lumpur


Traditional medicine is an evolutionary process as communities and individuals continue to discover new techniques that can transform practices. Many modern drugs have origin in ethnopharmacology and traditional medicine. Traditions are dynamic and not static entities of unchanging knowledge. Ayurvedic knowledge and experiential database can provide new functional leads to reduce time, money and toxicity - the three main hurdles in the drug development. Fairly long use of traditional medicine in communities provide first level safety evidence. New approaches such as phramcoepidemiology can be used to systematically document and analyze actual use of traditional medicine in the community. Most of these medicines are poly herbals; multi targeted, slow acting, need long term administration and may have disease modulating activities rather than direct agonist or antagonist activities. Moreover the diagnosis and treatment is more individualistic than generalized. All this calls for different models and protocols to evaluate true efficacy and clinical advantages of traditional medicine. It is also justifiably argued that instead of randomized controlled trials normally used as gold standard in routine biomedical research, strategies of pragmatic  clinical trials may be better suited for traditional medicine-inspired reverse pharmacology approaches Clinical research in Ayurveda requires proof of cause-effect relationship with multiple, reproducible trials. Each patient for each visit is considered as different entity. Concepts of clinical research practices include patient examination, diagnosis, treatment and analysis of post treatment effects using four criteria. Aapta: Unbiased judgment by peers; Pratyaksha: Objective observations; Anumana: Logical judgments; Yukti: Analysis considering multiple factors. Ayurveda also gives requirements of ideal physician and a better understanding of cause effect relationship is considered important. The individual constitution or Prakriti relevance in therapeutics indicate strong genetic connotation and can form basis of pharmacogenomics and personalized medicine. Various issues related to clinical research on traditional medicine will be discussed over this background.


Clinical Trials, Traditional Medicine


Symposium 4A-4


Quality and Safety of TCM Products