Rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) According to the diagnostic criteria of ACR / EULAR in 2010; (2) According to the diagnostic criteria of traditional Chinese medicine (TCM) syndrome type of Bi - wind cold dampness syndrome; (3) The age range is 18-70 years old, regardless of gender; (4) The X-ray staging of the joints of both hands belongs to stage I and II, and the joint function classification belongs to grade I, II and III; (5) 6 < DAS28 < 5. 1; (6) At least there was pain or swelling in both wrists; (7) Patients who use hormones, hormone suspects or biological agents need to stop taking drugs for more than 3 months; (8) Non steroidal anti-inflammatory drugs or topical analgesics were not used at least one week before enrollment. (9) The volunteers signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc; (2) Severe diseases such as cardiovascular diseases, lung diseases, liver diseases, gastrointestinal diseases, kidney diseases, hematopoietic system diseases or tumors, or acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.); (3) The patients with local skin damage, infection or trauma of the joints were not cured; (4) No response to methotrexate and leflunomide; (5) Contraindications of experimental drugs (pulmonary fibrosis, etc.) and allergic history were found; (6) History of alcohol abuse, drug abuse or neuropsychiatric disorders (epilepsy, depression, etc.); (7) Pregnant or lactating women have a family planning in the near future; (8) We are participating in clinical research of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Pain degree VAS score;DAS28 score;Number of joint swelling;Number of joint tenderness;Morning stiffness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Outcome Clinical Report PRO Scale Score;Joint function classification;Grip;Semi-quantitative evaluation of wrist ultrasound;Erythrocyte Sedimentation Rate (ESR);C reactive protein;Rheumatoid factor classification;Anti-cyclic citrullinated peptide antibody; | — |
Countries
China
Contacts
Yunnan Provincial Hospital of Traditional Chinese Medicine