Objective:To observe the clinical efficacy of Zishen Qingqi Granule combined with conventional therapy in the treatment of mildly to moderately active systemic lupus erythematosus (SLE) and effect of the drug on dosage of hormone therapy. MethodsSixty-four patients with SLE who met the inclusion criteria were randomly assigned into treatment group and control group, 32 patients in each group. The basic therapy was prednisone combined with hydroxychloroquine sulfate in both groups and in addition, the treatment group was given Zishen Qingqi Granule and the control group received placebo. The treatment course was 3 months in both groups. Changes in SLEDAI score, TCM syndrome score, dosage of hormone and relevant laboratory indicators (erythrocyte sedimentation rate, Complement C3 and C4, anti-ds-DNA antibody, alkaline phosphatase, serum calcium and phosphorus and osteocalcin) were observed.  Results:After treatment, the SLEDAI score, TCM syndrome score and dosage of glucocorticoids were significantly reduced in both groups (P＜0.05); they were significantly lower in the treatment group than in the control group (P＜0.05). After treatment, the ds-DNA level decreased in both groups (P＜0.05), and the other laboratory indicators had no statistically significant differences (P＞0.05). There were no significant differences in laboratory indicators between the groups after treatment (P＞0.05).  Conclusion:Zishen Qingqi Granule is effective in the treatment of SLE. It significantly improves TCM syndrome and helps to withdraw and reduce the dose of hormone.