The regulatory framework for clinical trials was drafted in India on 2005 but was not enforced in a proper manner. Now since 2 years this is being circulated especially by international research journals as a necessity to publish articles. This has made the registration of clinical trials as mandatory. As far as the herbal trials are concerned even today the registration of clinical trials have become optional and not mandatory as there lacks proper education of the same and its enforcement.

Canada has the most extensive regulation involving herbal medications. You should consult Canadian agency for the information.

Thank you. I have managed to download the Canadian guidelines. I am still interested in hearing the actual experiences and exchanges anyone has had with ethical and regulatory bodies in various countries and timelines to approval as well.

I have been a research nurse managing Clinical Trials in the UK. However, I must say that we have not used any herbal drugs in any of our trials. The closes that I can think of is the use of Probiotics and from experience there has been some problems with that trial as initially the Sponsors thought that it is classed as a food supplement. In the UK, running a clinical trial and a non-clinical trial involves a lot of differences, administrative-wise and regulatory-wise. To cut the long story short, the Sponsors were told that the Probiotics is classed as a clinical trial which entailed a lot of pharmacy and administrative work for the Sponsor.

With regards to your question, here is a reference from the MHRA (regulating body) in the Uk for drugs and devices. http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/index.htm

Thank you!

Am currently part of a team in advanced stages of conducting out a clinical trial in Uganda (it is actually a low risk study-an RTO) on medicinal plants used in the treatment of malaria in western and northern Uganda.

Initially we wanted to conduct a full clinical trial but we were advised to begin with a low risk study where it would be easier to obtain ethical approval and carryout the actual study. As a write now, we have obtain approval from the university ethical committee and waiting for approval from the National Council for Science and Technology in Uganda. Since this project is part of a larger consortium of universities in Africa and Europe, our colleague from Oxford university also submitted the same protocol to the tropical ethics committee of Oxford (OXTREC). The committee has responded with some queries which we hope to respond to. A similar study and protocol was used for a study in Mali and it was approved

Great, thanks! I recognize this work and have had a chance to discuss it with your collaborators on my contact visit at Oxford.