primary Sjogren's syndrome
Conditions
Interventions
Treatment group: HCQ+TCM placebo
Control group:HCQ+TCM placebo (1/10 dose)
Sponsors
Shanghai Association of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Meets the 2016 ACR/EULAR diagnostic criteria for pSS; 2)Meets the Traditional Chinese Medicine differentiation of yin deficiency with internal heat; 3)Aged between 18 and 80 years; 4) Voluntarily agrees to participate in this trial and agrees to sign the informed consent form for clinical research.
Exclusion criteria
Exclusion criteria: 1) Patients with systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, etc.; 2) Patients with HIV, hepatitis, or solid tumors; 3) Patients with fundus lesions; 4) Patients with cardiac conduction block; 5) Patients who have used other immunosuppressants or glucocorticoids in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry mouth visual analogue scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| EULAR Sjogren's syndrome patient reported index score;EULAR Sjogren's Syndrome Disease Activity Index score;Tranditional Chinese Medicine syndrome score;Assessment of Anxiety and Depression; | — |
Countries
China
Contacts
Public ContactHuiping Huang
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed