Rheumatoid arthritis
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients meeting the ACR / EULAR diagnostic criteria for RA in 2010; 2. Patients who meet the diagnostic criteria of traditional Chinese medicine syndromes of Bi cold dampness obstruction syndrome; 3. Subjects aged between 18 and 70 years, regardless of gender; 4. For the subjects whose X-ray staging of the joints of both hands belongs to stage I and II, the joint function classification belongs to grade I, II and III; 5. 2.6 < DAS28 < 5.1; 6. Subjects with at least 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. Patients who did not use NSAIDs or topical analgesics at least one week before enrollment. 9. Voluntary patients, signed 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. Patients with serious diseases such as cardiovascular, lung, liver, gastrointestinal tract, kidney, hematopoietic system or tumor, or complicated with various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.); 3. Subjects with local skin damage, infection or injury of the joints; 4. Those patients who have no response to methotrexate and leflunomide; 5. Patients with contraindications (pulmonary fibrosis, etc.) and allergic history of experimental drugs; 6. Patients with 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. Patients who are participating in clinical research of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of joint swelling;Number of joint tenderness;Morning stiffness time;VAS score of pain degree;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| grip;C-reactive protein;Clinical outcome report Pro scale score;Anti cyclic citrullinated peptide antibody;Semi quantitative score of wrist grip strength by ultrasound;Rheumatoid factor typing;Erythrocyte sedimentation rate (ESR);Classification of joint function; | — |
Countries
China
Contacts
Public ContactPu Yongbin
The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine
Outcome results
None listed