A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules
- Conditions
- Sjogren syndrome
- Registration Number
- ITMCTR2000003741
- Lead Sponsor
- Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. SS patients who meet the above diagnostic criteria of traditional Chinese and Western medicine.
2. Patients with moderate activity (essdai score 4-6).
3. Age of subjects: 18-65 years old.
4. Patients who have not used traditional Chinese medicine in the past, or have been interrupted for more than 2 months.
5. Women of childbearing age agreed to take effective contraceptive measures during the trial.
6. Patients who voluntarily sign informed consent and comply with the requirements of the study protocol.
1. Patients with severe or uncontrolled cardiovascular, liver, kidney, brain and hematopoietic system.
2. Patients with other connective tissue diseases, drug-induced lupus syndrome, tuberculosis and psychosis.
3. Pregnant or lactating women.
4. Patients with ALT or ast more than twice the upper limit of normal value, or total bilirubin greater than the upper limit of normal value.
5. Patients with allergic constitution.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tear film rupture time;ESR;Corneal fluorescent stain;Serum IgG;Schirmer's test;Saliva flow rate;Serum ß2 microglobulin;CRP;RF;
- Secondary Outcome Measures
Name Time Method Drug side effects;C3;Hormone withdrawal;C4;Number of relapses, degree of progress;