[Key points of protocol design on clinical therapeutic research of traditional Chinese medicine].

Therapeutic effect is the core in clinic medicine. Traditional Chinese medicine (TCM) has certain advantages on clinical efficacy, but is still lack of reliable evidence. With the rapid development of evidence based medicine (EBM), more and more attention is paid on scientific evaluation of clinical efficacy increasingly. To carry out TCM clinical therapeutic research and to scientifically evaluate its efficacy has become a very important task for TCM development. Scientific and precise protocol design is the precondition for progressing the research and obtaining high quality evidences. The article puts stress on how to design the clinical therapeutic program of research on TCM in combining with characteristics of TCM.