Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: Primary Sjogren's syndrome

• Registration Number: ITMCTR2000003900
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age of 18 to 75 years;
2. Fulfill the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria, with dry mouth or dry eyes;
3. Fulfill positive autoantibody (ANA or anti-SSA antibody or anti-SSB antibody or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
4. Fulfill the Yin deficiency and dryness-heat syndrome;
5. Patients were informed and voluntarily signed informed consent.

Exclusion Criteria

1. Diagnosed with other connective tissue diseases;
2. Glucocorticoids or biological agents have been used within 3 months before enrollment;
3. Pregnancy, preparation for pregnancy or breastfeeding;
4. Patients with severe mental and neurological disorders;
5. Patients with severe disease of heart, brain, lung, liver, kidney, hematopoietic system, etc.;
6. Patients with definite visual field defects, ocular fundus lesions, and severe arrhythmias (atrial fibrillation, atrioventricular block, etc.);
7. Patients are participating in other drug trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral dryness VAS;

Secondary Outcome Measures

Name	Time	Method
Pain VAS score;Eye dryness VAS score;C-reactive protein, CRP;ESSDAI score;SF-36 health survey;??Schirmer??;Erythrocyte sedimentation rate, ESR;Fatigue VAS score;Schirmer tests;Immunoglobulin (IgA, IgM, IgG)of serum;ESSPRI score;