Objective To observe the therapeutic effect of Ziyin Yangxue Qingre Formula (Formula for enriching yin,nourishing blood and clearing heat) on primary Sjogren's Syndrome (pSS).Methods Totally 64 female pSS patients were randomized into a treating group (33 cases),and a control group (31 cases).The control group was administered Hydroxychloroquine Sulfate Tablet.In addition,the treating group was prescribed Ziyin Yangxue Qingre Formula.Three-month treatment was as one course.After one course of treatment,the changes in symptom scores,salivation quantity,tear quantity,and immuno-infective indices were observed to compare the effect between both groups.Results The total effective rate of the treating group(87.88%) was significantly higher than that (64.52%) of the control group (P0.05).The total scores of symptoms,salivation quantity,and tear quantity of both groups were significantly improved,while the improvement in the treating group was more obvious than that in the control group (P0.05).In both groups,the C-reactive protein (CRP),erythrocyte sedimentation rate (ESR),immunoglobulin G (IgG),immunoglobulin A (IgA),and immunoglobulin M (IgM) were significantly improved than those before treatment (P0.05).The decrease of CRP and ESR in the treating group was more significant than that in the control group (P0.05).Conclusion Ziyin Yangxue Qingre Formula used together with Hydroxychloroquine Sulfate Tablet is more effective on pSS than single use of the Hydroxychloroquine Sulfate Tablet.