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

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Primary Sjögren's Syndrome (pSS)

Treatments: Drug: Yiqi Yangyin Formula; Drug: Yiqi Yangyin Formula placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07145060

2024-QNQS-07

Details and patient eligibility

About

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's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

Yiqi Yangyin Formula

Experimental group

Description:

The herbal prescription for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.

Treatment:

Drug: Yiqi Yangyin Formula

Yiqi Yangyin Formula placebo

Placebo Comparator group

Description:

The herbal prescription placebo for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.

Treatment:

Drug: Yiqi Yangyin Formula placebo