Objective To explore the clinical therapeutic effect of Jinju Qingrun Capsule（Capsule for Clearing Heat and Moistening Dryness） on primary Sjogren’s syndrome（PSS）.Methods In the double blind placebo controlled trial

100 PSS cases were randomized into a treatment and a control group with 50 in each.The treatment group was administrated Jinju Qingrun Capsule and prednisone simulation agent and the control group was given Jinju Qingrun Capsule simulation agent and prednisone.Eye drops was used for both groups.The course of treatment was 3 months.The clinical effect

TCM syndrome effect

and changes in saliva flow rate and tears flow rate and immunity indices were observed.Results The clinical total effective rate of the treatment group was better than that of the control group（P<0.05） and total effective rate of TCM syndrome effect of the treatment group was better than that of the control group（P<0.01）.There was a significant difference between two groups in improving the saliva flow rate and tears flow rate（P<0.05）.There was no significant difference between two groups in immunity indices after treatment（P>0.05）.Untoward reactions were not found in the treatment group.Conclusion Jinju Qingrun Capsule is effective in improving the clinical symptoms and TCM syndromes of PSS patients and it treats PSS through regulating the immunity system of patients.