Clinical study on the treatment of advanced rheumatoid arthritis (Phlegm stasis bi syndrome) by Soufeng Sanjie fomula for inhibiting bone erosio
- Conditions
- Rheumatoid arthritis
- Registration Number
- ITMCTR2200006853
- Lead Sponsor
- Jiangsu Integrated Traditional Chinese and Western Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria of RA and the syndrome differentiation criteria of TCM bi syndrome (phlegm and blood stasis bi); (2) The age ranged from 18 to 65; (3) Did not receive slow-acting anti-rheumatism drugs within 3 months before the study began; (4) No non-steroidal anti-inflammatory drugs, hormones or other drugs were taken within 2 weeks before the study; (5) Sign informed consent voluntarily.
(1) Lung interstitial disease; (2) With other connective tissue diseases; (3) Liver and kidney dysfunction (AST/ALT and SCr exceeding the normal upper limit); (4) Uncontrolled hypertension grade 2 and above; (5) Uncontrolled diabetes, or combined with diabetic target organ damage; (6) Previous history of gastrointestinal ulcer; Combined with serious cardiovascular and cerebrovascular diseases, blood, malignant tumors and other serious diseases; (8) Chronic infectious diseases, including hepatitis, tuberculosis, etc. (9) Patients who are participating in other clinical studies; (10) Male patients with fertility plans within six months, female patients with fertility plans, and patients during pregnancy and lactation; Suspected or proven history of alcohol or drug abuse or, in the investigator's judgment, likely to reduce or complicate enrollment
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of swelling;Joint tenderness;TCM syndrome score;Morning stiffness time;Visual analog pain scale score (VAS score);Inflammatory cytokines ;
- Secondary Outcome Measures
Name Time Method