Objective To explore the effectiveness and safety of modified Jianpi Runzao Tongluo Formula（健脾润燥通络方） in treating primary Sjogren′s syndrome（pSS） of spleen deficiency and collateral obstruction pattern. Methods Sixty pSS patients of spleen deficiency and collateral obstruction pattern were randomly divided into treatment group and control group

with 30 patents in each group. The treatment group was orally administered with Jianpi Runzao Tongluo Formula

one dose daily

while the control group was given oral hydroxychloroquine sulfate tablets

200 mg each time

twice daily

both groups treated for 12 weeks. The traditional Chinese medicine（TCM） symptom score

EULAR Sjogren′s syndrome patient reported index（ESSPRI）

EULAR Sjogren′s syndrome disease activity index（ESSDAI）

saliva flow

tear flow

erythrocyte sedimentation rate（ESR）

C-reactive protein（CRP）

immunoglobulin G（IgG）

complement 3（C3）

complement 4（C4）

and adverse events were assessed before and after treatment. Results The total effective rate of treatment group was 90.0%

significantly higher than 43.3% of control group（P<0.01）. Compared to those before treatment

TCM symptom score

ESSPRI and IgG in treatment group

as well as muscle pain scores in control group significantly decreased after treatment; the saliva flow

bilateral tear flow in treatment group

and saliva flow in control group significantly increased after treatment（P<0.05 or P<0.01）. When compared to the control group

treatment group had significantly better improvement on all TCM symptoms except for dry eyes

lower ESSPRI

and higher saliva flow and bilateral tear flow（P<0.05 or P<0.01）. Conclusion Jianpi Runzao Tongluo Formula can improve the clinical symptoms

increase saliva and tear flow

and reduce IgG when treating pSS patients of spleen deficiency and collateral obstruction pattern

and there are no significant adverse events.