Status:
NOT_YET_RECRUITING
A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Primary Sjögren's Syndrome (pSS)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT07145060
Start Date
September 1 2025
End Date
March 31 2028
Last Update
August 28 2025
Active Locations (1)
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1
China-Japan friendship hospital
Beijing, Beijing Municipality, China, 100029