A Multicenter, Prospective, Observational Real-World Study of Bushen Tongluo Decoction for the Treatment of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- ITMCTR2024000054
- Lead Sponsor
- The Affiliated Hospital of Gansu Traditional Medicine University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meets the aforementioned Western medical diagnosis, traditional Chinese disease classification, and syndrome diagnosis.
(2) Age range between 35 and 60 years.
(3) Classified with joint function levels I, II, or III, and hand X-ray staging falls under stages I, II, or III.
(4) RA disease activity is mild to moderate.
(5) Has not recently taken or been administered non-steroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs (DMARDs), biologics, glucocorticoids, or similar medications intended to alleviate symptoms or improve rheumatoid arthritis condition.
(1) Patients who do not meet the diagnostic criteria.
(2) Patients who have used glucocorticoid medications continuously for more than one month in the last six months (such as oral prednisone, methylprednisolone, or intravenous methylprednisolone).
(3) Patients with concomitant other rheumatic diseases.
(4) Patients who have taken medications in the past year that promote bone formation or absorption, such as calcium supplements, calcitriol, or teriparatide.
(5) Patients with acute cardiovascular or cerebrovascular diseases.
(6) Patients with significant concurrent systemic diseases, severe trauma, planned surgery, or severe infections.
(7) Patients with a history of drug abuse, allergies to the medications used in this study, or a history of mental illness.
(8) Women who are pregnant, breastfeeding, or in the preconception period.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Pain Scale (VAS scale);TCM symptom score;adverse reaction;
- Secondary Outcome Measures
Name Time Method Acute phase reactants;bone mineral density test;appraisal of life quality;imageological examination;