Abstract: In the clinical trial of new traditional Chinese medicine, because of the special characteristics and particularity in the diagnosis and treatment system of TCM, the choice of the positive control medicine always face some problems. Which affects the validity of clinical drug evaluation seriously. We present a new concept of “composite control”. The new concept provides new ways, which is widely used in the choice of the positive control medicine in the clinical trial of TCM. It has real-istic significance to research the validity of clinical drug evaluation.

Key words: new traditional Chinese drug, clinical trial, positive control medicine, choice, composite control