Rheumatoid Arthritis
Conditions
Interventions
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Xiaqiong Ointment , Usage: Topical application to the affected area, 4 g per lesion site, three
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Xiaqiong Ointment Mimic (Placebo) , Usage: Topical application to the affected area, 4 g per le
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 the cold-damp obstruction syndrome of Changzhong disease in Tibetan medicine. 3. No gender restrictions, age between 18 and 70 years (inclusive of 18 and 70 years old). 4. The target wrist joint can be clearly diagnosed with synovial inflammation based on clinical symptoms, signs, or joint ultrasound. 5. Before enrollment, participants have received =1 type of disease-modifying antirheumatic drug (csDMARDs) other than methotrexate, with a stable drug dose for =3 months, and the dose remains stable 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 RA in Western medicine or the diagnostic criteria for the cold-damp obstruction syndrome ofdisease in Tibetan medicine. 2. Individuals under 18 years of age or over 70 years of age. 3. Those who have experienced a miscarriage or termination of pregnancy within the past 3 months, or are currently pregnant, breastfeeding, or planning to conceive. 4. Individuals with allergies to the drugs involved in the study or contraindications for their use. 5. Visual Analog Scale (VAS) score for joint pain in the target wrist (10 cm) =2 or =8. 6. RA joint functional classification grade IV, with severe joint deformity. 7. Those with skin ulcers, skin diseases, or skin allergies in the target joint. 8. Overlapping severe autoimmune diseases other than 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. Participants with severe pulmonary interstitial changes, tuberculosis, malignant tumors, heart failure, or severe primary diseases of the cardiovascular, digestive, respiratory, or hematopoietic systems. 10. Individuals with mental illness, significant mental disorders, or infectious diseases (e.g., HIV/AIDS, tuberculosis, viral hepatitis). 11. History of bleeding in skin/mucosa, digestive tract, or visceral organs; coagulation disorders (e.g., hypercoagulable state, idiopathic thrombocytopenic purpura); or moderate, severe, or extremely severe anemia. 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. Participants who received glucocorticoid therapy prior to enrollment, with oral doses >10 mg and insufficient stabilization for 4 weeks, or discontinuation <1 week prior to enrollment. 15. Participants who received nonsteroidal anti-inflammatory drug (NSAID) therapy prior to enrollment, with low-dose stabilization <4 weeks, or discontinuation <1 week prior to enrollment. 16. Individuals with substance abuse, drug dependence, or addiction. 17. Participants deemed by the investigator to have poor compliance, inability to assess efficacy, or inability to complete the expected treatment course or follow-up. 18. Participants who have 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 quantitative scoring;Joint function grading; Hand grip strength;Erythrocyte Sedimentation Rate(ESR);C-reactive protein(CRP);Disease Activity Score in 28 joints with Erythrocyte Sedimentation Rate(DAS28-ESR);Patient Global Assessment(PGA);Medical Doctor's Global Assessment(MDGA);Health Assessment Questionnaire(HAQ);Chinese Rheumatoid Arthritis Patients' Self-Reported Disease Activity Index Scale(CPRI-RA);Tibetan Medical Score for "Cold-Dampness Obstruction Syndrome" ;Dosage of rescue medication (Diclofenac Sodium Enteric-coated Tablets); | — |
Countries
CHina
Contacts
Public ContactPeng Jiangyun
Yunnan Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed