Dear Dr. Aejazuddin,

First of all it depends on which country you would like to run the trials/experiments in and which country you would like the drug to be approved in. Then it depends on whether its a single drug or a compound drug. Of course it is of extreme importance to know, what research (botanical, ethnomedical, phytochemical, pharmacological, toxicological) has previously been conducted on the respective drug. Without good evidence for safety and efficacy from in vitro or in vivo studies, you should not even consider starting any application for clinical trials. Finally, I think it is often more appropriate to run observational studies rather than randomized, controlled clinical trials with traditionally used herbal drugs as the ethical dimension is slightly less complex and such a setting allows for the inclusion of healing practices which might influence the therapeutical outcome via the meaning response. Please, if asking such questions be more precise as otherwise it is not possible to give you any meaningful answer.

First place would be the where the evaluation will take place, secondly the laws governing such study.This will provide first step in initiating your proposal.The other source of information is WHO trial registry for complementary medicine.

hi,

in India, it is protectedby DEPARTMENT OF AYUSH.  and patents are available on plants studeis.

If you are using herbs, I would run a clinical trial. If you are evaluating a procedure (body manipulation, pressure points, touch, etc) I would use a novel approach called comparative effectiveness research.