The syndrome differentiation and efficacy evaluation criterion of diabetes has become a bottleneck restricting the TCM clinical research. The thesis reviewed the previous released standards of the industry, society, departments of medical administration, and food and drug administration. It brought out ideas on criteria of defining a single syndrome and comprehensive evaluation of clinical efficacy. On the basis of going through ancient and modern literature, two rounds of questionnaire surveys on experts were conducted. Exploratory statistical analysis methods were applied in the multi-center prospective study of clinical syndromes, and the norms of TCM syndrome differentiation and efficacy evaluation of diabetes were initially drafted.