[Chinese medicine clinical trial protocol design and report specifications].

Clinical trial protocol is the document that illustrates the background of a clinical trial, theoretic basis, objective, design, methods, and organization, as well as statistical calculating, implement, and conditions for completion. Clinical trial protocol is the basic measure for ensuring the validity of scientific results and reducing bias. In order to optimize the design of clinical trial protocol, we generalize main problems in Chinese medicine clinical trials, key points of clinical trial protocol, as well as report standards.