To evaluate the efficacy and safety of the therapy of clearing heat by tonifying spleen and invigorating kidney on treating primary Sjogren’s Syndrome(PSS). Methods: A total of 45 patients with PSS participated in the study and received treatment based on the therapy of clearing heat by tonifying spleen and invigorating kidney for 12 weeks. TCM syndrome integrals, dry mouse(VAS), dry eyes(VAS), ESR, CRP, RF, IgG, IgA, IgM and the safety indexes were evaluated in first week and 12th week. The side effects were recorded and the effectiveness evaluated. Results: At 12th weeks, the TCM syndrome integrals, dry mouth(VAS), dry eyes(VAS), ESR, CRP, IgG were significantly reduced with statistical difference （P<0.01）. There was no statistical difference in RF, IgA, IgM（P>0.05）. In the 45 patients, there were 19 patients showed significant effectiveness, 18 patients had effectiveness and 8 patients showed no effectiveness. The total effective rate was 82.2%. Conclusion: Clearing heat by tonifying spleen and invigorating kidney has efficacy on treating PSS. The therapy could improve the condition of PSS patients with dry mouth, dry eyes, TCM syndrome integrals and inflammation index.