A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome

Inclusion criteria

• Patients aged18-75 years old (including the critical value), gender not limited;
• Patients meeting the classification criteria of primary Sjogren's syndrome in ACR/EULAR 2016;
• Patients with dry mouth VAS ≥4 and ESSDAI score < 5;
• Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
• Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;
• The subjects were informed and voluntarily signed the informed consent form.

Exclusion criteria

• Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;
• Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;
• Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;
• Patients who are pregnant, preparing for pregnancy or breastfeeding;
• Patients who have used cholinergic drugs or artificial tears/saliva in last 1 week;
• Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;
• Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;
• Patients who have used Leflunomide in last 6 months;
• Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;
• Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;
• Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).