Rheumatoid Arthritis
Conditions
Interventions
Treatment group:(1) Methotrexate Tablets Usage: Oral administration, 10 mg per dose, taken 30 minutes after lunch
once weekly, for a 4-week medication course. (2) Folic Acid Tablets Usage: Oral administration, 10 mg per dose, taken 30 minutes after lunch
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Shedu Ointment Usage: Topical application to the affected area, 4 g per lesion site, three time
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Shedu Ointment Mimic (Placebo), Usage: Topical application to the affected area, 4 g per lesion
Sponsors
Yunnan Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for RA in Western medicine. 2. Meets the diagnostic criteria for medical cold-damp arthralgia syndrome. 3. No gender restrictions, age between 18 and 70 years (inclusive of 18 and 70 years old). 4. The target wrist joint synovial inflammation can be clearly identified based on clinical symptoms, signs, or joint ultrasound. 5. Before enrollment, participants have received =1 type of disease-modifying antirheumatic drugs (csDMARDs) other than methotrexate, with stable drug dosage for =3 months, and will maintain stable dosage during the trial. 6. Participants are fully informed and voluntarily join this study, agree to sign the informed consent form for clinical research, and can actively cooperate with medical treatment, observation, and follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who do not meet the diagnostic criteria for Western medical diagnosis of RA or medical diagnosis of cold-dampness arthralgia. 2. Age under 18 years or over 70 years. 3. Those who have had a miscarriage or termination of pregnancy within the past 3 months, or are currently pregnant, breastfeeding, or planning to conceive. 4. Those allergic to the drugs involved in the study or with contraindications for their use. 5. Visual Analog Scale (VAS) score for target wrist joint pain (10cm) =2 or =8. 6. RA joint functional classification grade IV with severe joint deformity. 7. Those with skin breakdown, skin diseases, or skin allergies at the target joint. 8. Those with other overlapping autoimmune diseases in addition to RA, such as severe osteoarthritis, systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis/dermatomyositis, psoriatic arthritis, ankylosing spondylitis, or other connective tissue diseases. 9. Those with severe pulmonary interstitial changes, tuberculosis, malignant tumors, heart failure, or other severe primary diseases of the cardiovascular, digestive, respiratory, or hematopoietic systems. 10. Those with mental illness, obvious mental disorders, or infectious diseases (e.g., AIDS, tuberculosis, viral hepatitis, etc.). 11. History of bleeding in skin/mucosa, digestive tract, or visceral organs; coagulation disorders (e.g., hypercoagulable state, idiopathic thrombocytopenic purpura, etc.); or anemia (moderate, severe, or extremely severe). 12. Abnormal laboratory indicators at screening: total white blood cell count 1.5 times the upper limit of normal, BUN or Cr >1 times the upper limit of normal. 13. Use of biologics or JAK inhibitors within 30 days prior to enrollment. 14. Those who received glucocorticoid therapy prior to enrollment, with oral steroid dose >10mg before entering the clinical study, and insufficient stabilization time (<4 weeks), or discontinuation time <1 week. 15. Those who received non-steroidal anti-inflammatory drug (NSAID) therapy prior to enrollment, with low-dose stable use <4 weeks, or discontinuation <1 week. 16. Users or abusers of psychoactive substances or drugs. 17. Those deemed by the investigator to have poor compliance, inability to assess efficacy, or inability to complete the expected treatment course and follow-up. 18. Those who participated in other drug or medical device clinical trials within 3 months prior to signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint Pain Visual Analog Scale(VAS)Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wrist Joint Ultrasound Semi-Quantitative Scoring;Joint Function Grading; Hand grip strength;Erythrocyte Sedimentation Rate;C-reactive protein;Disease Activity Score in 28 joints with Erythrocyte Sedimentation Rate(DAS28-ESR);Patient's Global Assessment of Disease Activity;Physician's global evaluation of disease activity;Health Assessment Questionnaire(HAQ);Chinese Rheumatoid Arthritis Patients' Self-Reported Disease Activity Index Scale;Wazi cold-damp arthralgia obstruction syndrome scoring system;Rescue medication (Diclofenac sodium enteric-coated tablets) dosage; | — |
Countries
China
Contacts
Public ContactPeng Jiangyun
Yunnan Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed