Primary Sjogren's syndrome
Conditions
Interventions
Control group:Hydroxychloroquine sulfate tablets 200mg bid po and Huashi Runzao Formula Placebo 200mL bid po
Experimental group:Hydroxychloroquine sulfate tablets 200mg bid po and Huashi Runzao Formula 200mL bid po
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 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 dryness and dampness syndrome; 5. Patients were informed and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with other connective tissue diseases; (2) Have used hormone or biological immunosuppressive agents within the first 3 months of selection; (3) Pregnant or lactating patients; (4) Patients with severe mental and neurological disorders; (5) Patients with severe lesions in the heart brain lungs liver kidneys hematopoietic system etc; (6) Clear visual field defects fundus lesions and severe arrhythmias (such as atrial fibrillation atrioventricular block etc.); (7) Participants in other drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral dryness Visual Analogue Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Saliva flow rates;Fatigue Visual Analogue Scale score;Eye dryness Visual Analogue Scale score;C-reactive protein CRP;Erythrocyte sedimentation rate ESR;SF-36 health survey;Immunoglobulin (IgA IgM IgG) of serum;Schirmer tests;EULAR Sjogren's Syndrome Disease Activity Index score;Pain Visual Analogue Scale score;EULAR Sjogren's Syndrome Patient Reported Index score; | — |
Countries
China
Contacts
Public ContactLuoJing
China-Japan Friendship Hospital
Outcome results
None listed