Primary Sjogren's syndrome
Conditions
Interventions
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral dryness VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Eye dryness VAS score;Fatigue VAS score;Pain VAS score;ESSPRI score;ESSDAI score;Schirmer tests;??Schirmer??;Immunoglobulin (IgA, IgM, IgG)of serum;Erythrocyte sedimentation rate, ESR;C-reactive protein, CRP;SF-36 health survey; | — |
Countries
China
Contacts
Public ContactLuo Jing
China-Japan Friendship Hospital
Outcome results
None listed