Clinical research on ayurvedic therapeutics: myths, realities and challenges.

Globally there is an increasing interest in alternative routes to health such as ayurveda. There is a need to conduct globally acceptable clinical research in ayurvedic therapeutics (AT). Some of the issues in investigating AT in randomised clinical trials (CT) are: selection of appropriate AT, non-drug and/or drug AT, identification of objective outcomes, devising adequate placebo/positive controls, difficulties of blinding, guarding against bias, duration of trials, number of patients, dose optimisation, etc. There is also a need to establish reasonable safety of this therapy in CT. If AT has to complete with new chemical entities and biotechnology products, clinical research and development of AT should be focussed on unmet medical needs utilising principles and practices of modern CT approaches.