Rheumatoid Arthritis
Conditions
Interventions
Traditional Chinese Medicine Group:In addition to the control group, the (Jiawei Huangqi Guizhi Wuwu Decoction) was administered, with the following prescription: Astragalus membranaceus 15g, Cinnamom
Control Group:The control group patients received Western medicine treatment, specifically oral methotrexate. The dosage was 10 mg per administration, once weekly. The dosage was 5 mg per administrati
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the 2010 ACR/EULAR classification criteria for rheumatoid arthritis; 2. Meets the AWGS2019 consensus diagnostic criteria for sarcopenia; 3. Meets the diagnostic criteria for "liver-spleen disharmony" syndrome of rheumatoid arthritis as specified in the "National Standard of the People's Republic of China: Clinical Diagnostic and Therapeutic Terminology in Traditional Chinese Medicine (Symptom-Complex Section)"; 4. Patients who are using nonsteroidal anti-inflammatory drugs (NSAIDs), prednisone (=10mg/d), or equivalent hormone therapy at the time of screening must have been on a stable dose for at least 4 weeks; if not taking such medications, they must have been off them for at least 1 week; 5. Age 18 to 65 years, gender; 6. Voluntarily sign the informed consent form for the clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients with severe complications of RA, such as secondary severe infections or vasculitis; 2. Patients with other connective tissue diseases, such as systemic lupus erythematosus, ankylosing spondylitis, or dermatomyositis; 3. Patients with severe and unstable cardiovascular diseases, acute or uncontrolled conditions, chronic diffuse connective tissue diseases, or those with uncontrolled severe hypertension (blood pressure > 160/110 mmHg) or diabetes (fasting blood glucose > 11.1 mmol/L) despite treatment; 4. Patients with severe active rheumatoid arthritis (DAS28-ESR > 5.1 or DAS28-CRP > 5.1); 5. Patients who received treatment with disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (e.g., sulfasalazine, hydroxychloroquine, D-penicillamine, azathioprine, cyclosporine, cyclophosphamide, or Tripterygium formulations) within 4 weeks prior to enrollment; 6. Patients who received leflunomide treatment within 12 weeks prior to enrollment (if standard cholestyramine washout therapy has been completed [8g orally, 3 times/day, for 11 consecutive days], at least 4 weeks of drug discontinuation prior to enrollment is required); 7. Patients who used biologics (including tumor necrosis factor (TNF) a-inhibitors [e.g., etanercept, infliximab, and adalimumab], interleukin (IL)-1, and IL-6 inhibitors) within 24 weeks prior to enrollment; 8. Patients with active peptic ulcers in the past year or ulcers complicated by bleeding or perforation; 9. Patients with active liver disease or abnormal liver function (ALT or AST = upper limit of normal); 10. Patients with abnormal renal function (Scr = upper limit of normal); 11. Pregnant women, those planning pregnancy, or breastfeeding women; 12. Patients currently participating in other clinical trials; 13. Patients with mental disorders, lack of insight, inability to express themselves clearly, or inability to cooperate to complete this study; 14. Patients deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score reduction rate;ACR20 (American College of Rheumatology 20) Improvement Rate;Quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| limb skeletal muscle mass;L3 cross-sectional view, skeletal muscle area, visceral fat area, subcutaneous fat area, intermuscular fat area; | — |
Countries
China
Contacts
Public ContactJiang Ping
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed