Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07145060
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07145060
Study Brief:
Protocol Section:
NCT07145060