groups » Clinical trials » Ethical Review Issues in Clinical Trial of Herbal Medicine

Clinical trial protocol of herbal medicine most times do face a great challenge when submitted to ethical committee for review. The EC desires to know if the drug/herbal product or the preparation is listed in the pharmacopeia before any review can be initiated. Please what is your experience in this area of research? How did you overcome same? I will appreciate if you could please share your ideas.

Reply

  • merlinwillcox Merlin Willcox Aug. 4, 2014

    I think not all ethical committees will require this. I have collaborated in clinical trials of herbal medicines in Uganda, Mali and Madagascar. The herbs we trialled were not on the pharmacopoeia at that time, and yet the trials were approved by the ethics committees in each country. Similarly a clinical trial is being planned of a herbal medicine consisting of a mixture of 3 plants in Burkina Faso. The ethical committee has sent their feedback but the lack of a monograph in the pharmacopoeia was not one of their comments. The key is to constitute a good "Investigator's brochure" summarising everything that is known about the plant, i.e. a comprehensive literature review + details of all your previous work which supports the safety and efficacy of the plant(s) and justifies the proposed clinical trial.

  • I think you are right Merlin. Based on the little discussions we had at the ethical committee's office during your visit to Nigeria for the just concluded MUTHI workshop, you will agree with me that there is the need to educate and strengthen several ethical committees in this part of the world on the need to develop interest in reviewing clinical trial protocols on herbal medicine. Once this bias is removed, many herbal products shall get their way into the pharm shelf and doctors will be confident to prescribe them as well. It is a task that will be possible in no time.

  • Speaking about pharmacopeia, why can we not develop one with our local plants? I think that enough research has been done on various plants to provide enough information. Whether we like it or not people will keep on using herbal medicines in this country, so the more liberal our Ethical Committees are the better and safer for everyone.

  • moneratg Tsitsi G. Monera-Penduka April 15, 2015

    Strengthening capacity for review boards is imported. I am conducting a herbal clinical trial in Zimbabwe which required 5 levels of institutional and national ethical and regulatory review boards. It was a lengthy process of discussion and when we provided sufficient rationale and justification, approval was granted. It doesn't necessarily have to be in a pharmacopeia but a good systematic review should be made available.

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