To explore the clinical curative effect of Gushen agent in the treatment of diabetic kidney disease of qi-yin deficiency and collaterals stasis pattern. Methods: The 117 patients with diabetic nephropathy who met selection criteria were included and were randomly divided into treatment group 62 cases and control group 55 cases by the random number table method. Both of the two groups received conventional treatment. Patients in the treatment group were additionally treated with Gushen agent at the same time and the control group at the same time for 8 weeks. TCM Clinical symptoms, 24 h urine trace albumin, 24 h urine protein quantitative, fasting plasma glucose (FPG), blood sugar 2 hours after meal (2 h PG) measures of the two groups were compared. Results: Symptoms integral of the two groups before and after medication showed no significant difference (P>0.05). Clinical control rates for renal function evaluation of patients with diabetic nephropathy of the two groups were respectively was 29.03% in the treatment group and 32.73% in the control group. Differences in curative effect of the two groups showed no statistical significance (P>0.05). 24 h urine trace albumin, 24 h urine protein, fasting blood sugar and 2 h postprandial blood sugar medicine level before and after the treatment of the two groups indicated no statistically significant difference (P>0.05). TCM Syndrome efficacy evaluation of the two groups showed the efficiency of the treatment group was 19.35% and that of the control group was 21.82% with no significant difference (P>0.05). Conclusion: Gushen agent has equal effect in relieving clinical symptoms and reducing proteinuria of diabetic nephropathy of qi-yin deficiency and collaterals stasis pattern.