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Clinical study on the treatment of advanced rheumatoid arthritis (Phlegm stasis bi syndrome) by Soufeng Sanjie fomula for inhibiting bone erosio

Phase 1
Recruiting
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
Inclusion Criteria

(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.

Exclusion Criteria

(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
NameTimeMethod
umber of swelling;Joint tenderness;TCM syndrome score;Morning stiffness time;Visual analog pain scale score (VAS score);Inflammatory cytokines ;
Secondary Outcome Measures
NameTimeMethod
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