The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study
- Conditions
- rheumatoid arthritis
- Registration Number
- ITMCTR2000003729
- Lead Sponsor
- Shuguang 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. According to the diagnostic criteria of RA, it is in accordance with the diagnostic criteria of RA in active stage, in accordance with the diagnostic criteria of traditional Chinese medicine;
2. Patients aged 18-80 years old;
3. The dosage of corticosteroids was stable for at least 30 days before entering the trial, and remained unchanged in the following treatment. Patients receiving other DMARDs had to discontinue other DMARDs for more than 30 days;
4. At least 30 days before entering the trial, no NSAIDs were taken;
5. Sign the informed consent to enter the clinical study.
1. Patients with pulmonary interstitial disease and elevated liver enzymes (ALT > 2 times normal value);
2. Pregnant and lactating women or patients who are ready to give birth in the near future;
3. Allergy to the test drug or allergic constitution;
4. Severe primary diseases, such as heart, liver, kidney, brain, endocrine system and hematopoietic system, were complicated;
5. Overlap other rheumatic diseases, such as systemic lupus erythematosus, Sjogren's syndrome, myositis, etc.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DAS28;Erythrocyte sedimentation rate;VAS test;Musculoskeletal ultrasound (synovitis);Musculoskeletal ultrasound (synovitis of tendon sheath);Musculoskeletal ultrasound (bone erosion);C-reactive protein;
- Secondary Outcome Measures
Name Time Method VEGF;CX3CL1;MMP-9;TCM syndrome curative effect score;HAQ Disability Index, HAQ-DI;TNF-a;Joint tenderness count;Joint swelling count;iNOS;