Diabetic nephropathy is now the hotspot of clinical researches. It is of great importance to study its TCM syndrome differentiation and efficacy evaluation criteria. The thesis reviewed the previous released standards of the industry, society, departments of medical administration, and food and drug administration. 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 diabetic kidney disease were initially established.