Today more than ever, traditional herbal medicine is receiving scientist’s attentions in order to stimulate evidence-based research and proper archiving. Although practitioners claim that use of traditional herbal medicines can make a real difference in various therapies, there are still doubts about the monitoring of herbal practitioners, and the safety and accuracy of their therapies. Certain studies have recorded adverse reactions leading to serious damages (Journal of Chinese Medicine 1996) ^[1]. The World health organisation, with the help of 19 member countries, is setting up an International Regulatory Cooperation for herbal Medicines (IRCH) ^[2] (as from November 2005). Its aim is to protect and promote public health and safety through improved regulation for herbal medicines. The British Government, member of this committee, along with national and international health bodies is reviewing its legislation concerning the use of traditional herbal medicines. The conventional legislation of the Medicines for Human Use (Clinical Trials) Regulations 2004 ^[3] had some limitations regarding its enforcement on traditional herbal medicines. The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 ^[4] was therefore introduced to give to The Medicines and Healthcare products Regulatory Agency (MHRA 2007) more legislative power and responsibility concerning the management of herbal medicines on the U.K market. The statutory document is based on the Traditional Herbal Medicinal Products Directive 2004/24 EC ^[5] by the European Union Directive. It ensures specific safety and quality standards of traditional herbal medicines on the British market. However, there is still a transitional period for old products on the market to comply with the new legislation by 2011 (MHRA 2007) ^[6].

This project is specially designed to assess the use of these traditional herbal medicines. With the transitional period of the new legislation, the project is based on the rules of the 2004 conventional legislation. The legislation will regulate the use of a highly consumed traditional herbal medicine, Cinnamomum, in a phase 1 Clinical Trials study.

Aim: The aim of this project is to carry out a herbal medicines clinical trials under the Human Use (Clinical Trials) Regulations 2004 set up by The Medicines and Healthcare products Regulatory Agency (MHRA).

Objectives: The objective of this project will mainly be focused on:

1.    Application of the Medicines for Human Use (Clinical Trials) Regulations 2004 to the analysis of Traditional Herbal Medicines.

2.    Ensure the use of the most appropriate documents, without causing any harm to the patient’s rights, safety and welfare according to Good Clinical Practice.

Hence, Cinnamomum will be tested as a main product in a phase 1 Clinical Trials. This will help to compare the limitations of the conventional legislation compared to the new legislation at the end of the project. A full report will be documented at the end of the study.