To explore the efficacy of Yishen Huashi Granule in the adjuvant treatment of early diabetic nephropathy，and to evaluate the safety of medication.Methods:From January 2015 to November 2018，a total of 80 patients with early diabetic nephropathy who were first diagnosed and treated in Traditional Chinese Hospital of Luan Nephropathy，were divided into a control group and an observation group by random number table.Patients in the control group underwent routine Western medicine treatment，while those in the observation group were treated with Yishen Huashi Granule on the basis of the control group.The curative effects were evaluated after 4 weeks of continuous treatment.The therapeutic effects，TCM syndrome scores，serum endothelial function indexes［(NO，ET-1)］ and oxidative stress indexes［(8-OHDG，MDA，GSH-Px，SOD)］ were compared between the 2 groups，and the occurrence of adverse drug reactions during medication were also compared.Results:The total effective rate of treatment in the observation group was higher than that in control group; The scores of TCM syndromes such as fatigue，dry mouth and throat，soreness and weakness of waist and knee，spontaneous and night sweating，purple lips，fat tongue and teeth marks were lower than those in the control group; Serum level of NO was higher than that in control group and ET-1 level was lower than that in control group; Serum levels of 8-OHDG and MDA were lower than those in control group，and GSH-Px and SOD levels were higher than those in control group(P<0.05).During medication，there were no significant difference in the incidence of pruritus，rash，dizziness，headache，nausea and vomiting between 2 groups(P>0.05).Conclusion:The adjuvant treatment of Yishen Huashi Granule can improve the curative effects of patients with early diabetic nephropathy，and has good medication safety.