Objective To observe the effect of TCM treatment on quality of life in the patients of diabetic nephropathy （DN） with renal failure. Methods Multi-centered randomized-controlled

single-blinded design was carried out. The selected 221 diabetic nephropathy patients were randomized into TCM treatment group

Losartan group

and TCM treatment + Losartan group. Use WHO QOL-BREF and DQOL before treatment and 3 months after treatment respectively to evaluate the quality of life （QOL）. Results All the treatment plans could increase the scores of QOL and self-scoring and decrease the influence of disease on physiological function and psychological state. Compared with before treatment

there was a significant difference （P<0.05 or P<0.01）. Among all the three groups

there was a significant difference in self-scoring of patients before and after treatment（P<0.05）. There was no significant difference among groups in changes of other scores of QOL after treatment（P>0.05）. The result of intention-to-treat （ITT） analysis and PP analysis accorded with each other. Conclusion The TCM treatment based on the diet

glucose control

and symptomatic treatment can improve the quality of life of the patients with diabetic nephropathy. The TCM treatment may have advantage in increasing the self-scoring of patients.