primary Sjogren's Syndrome
Conditions
Interventions
low disease activity-experimental group:Jiedu Tongluo Shengjin prescription
low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo
moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription
moderate disease activity-experimental group:prednisone 10mg/d
moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d
moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo
moderate disease activity-control group:prednisone 10mg/d
moderate disease activity-control group:Hydorxychloroquine 0.2g/d
Sponsors
Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~70 years old; 2. Conventional medicine diagnosis according with the 2002 American and European standards for the classification of pSS; 3. TCM disease diagnosis accord with , TCM Syndrome Types diagnosis accord with 1997 National Standard yin deficiency type and damp heat type. 4. No history of treatment with DMARDs and traditional Chinese medicine in past 8 weeks; 5. If use Glucocorticoid,the prednisone dose must below 10mg/d and stable at least one month. 6. Voluntarily sign informed consent, and comply with the requirements of the research program.
Exclusion criteria
Exclusion criteria: 1. Combined with other connective tissue diseases, drug lupus syndrome, tuberculosis and psychosis; 2. Combined with severe or not control primary diseases in cardiovascular, cerebrovascular, liver, kidney and blood system; 3. ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin is greater than the upper limit of the normal value; 4. With hydroxychloroquine use taboo,like Retinal pigment degeneration, Cardiac conduction; block (PR=0.20sQRS=0.08s); 5. Allergic constitution; 6. Pregnancy, prepare to pregnancy and lactation women; 7. Do not want to participate in or can not strictly comply with the research program requirements; 8. Being in other drug trials; Those who meet one of the above circumstances, are not included in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESSPRI; | — |
Countries
China
Contacts
Public ContactXue Luan
Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine
Outcome results
None listed