Based on the thoughts on the evaluation of 6 types of new drug of compound traditional Chinese medicine for the acute gouty arthritis applied in recent years, this article made the preliminary study on the key points of the clinical trial design of TCM new drug, and also elaborated on clinical orientation, the choice of subjects, control design, treatment course and follow-up visit.The validity index selection was especially explained and discussed combined with safety index design of applied drugs containing toxic herbs and quality control of the clinical trials.