Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
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 (TCM) syndromes of Bi dampness heat obstruction syndrome; 3. Subjects aged between 18 and 70, 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. Patients with at least pain or swelling of both wrists; 7. Patients who use hormones, hormone suspects or biological agents need to stop taking drugs for more than 3 months; 8. Subjects who did not use NSAIDs or topical analgesics 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. 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. No response to methotrexate and leflunomide; 5. Subjects with contraindications (pulmonary fibrosis, etc.) and allergic history of experimental drugs; 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. Subjects who are participating in clinical research of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Curative effect of Chinese medicine disease;TCM syndrome score;DAS28 score;Number of joint swelling;Number of joint tenderness;Morning stiffness;Pain degree VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Outcome Clinical Report PRO Scale Score;Joint function classification;VAS score for the overall condition of the disease assessed by the patient;VAS score for the overall condition of the disease as assessed by the investigator;ACR20 compliance ratio;Grip;Semi-quantitative evaluation of wrist ultrasound;Erythrocyte Sedimentation Rate ;C reactive protein;Rheumatoid factor classification;Anti-cyclic citrullinated peptide antibody; | — |
Countries
China
Contacts
Public ContactWu Yang
Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Outcome results
None listed