Rheumatoid Arthritis
Conditions
Interventions
Treatment group:Modified Qianyang Fengsui Dan + Methotrexate Tablets + Folic Acid Tablets
Control group:Methotrexate + Folic Acid
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Comply with the classification criteria of rheumatoid arthritis in Western medicine: the RA classification criteria and scoring system jointly formulated by ACR and EULAR in 2010; 2. Comply with the syndrome differentiation standard of TCM (cold and heat mixed syndrome); 3. Aged between 18-70 years (including 18 and 70 years old), no gender limit; 4. Patients who use biological DMARDs need to stop the drug for 30 days; 5. Patients treated with oral glucocorticoids should have a stable drug dose for at least 30 days before entering the study, and the oral dose should be less than or equal to 10 mg; 6. Those whose joint function is in grades I-III; 7. 2.6 points <DAS28<=5.1 points; 8. Those who voluntarily participate in this trial and agree to enter the clinical research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a history of severe respiratory, blood circulation, digestive tract, endocrine, urinary system diseases and malignant tumors before participating in the trial; 2. RA patients with advanced stage, severe joint deformity, joint function in stage IV, X-ray stage III; 3. Patients with other rheumatic diseases such as ankylosing spondylitis, Sjogren's syndrome, systemic lupus erythematosus, etc.; 4. Patients who are receiving biological DMARDs other than methotrexate; 5. When the patient is screened, the relevant laboratory indicators are abnormal, the total number of white blood cells is less than 3.5 x 10^9/L, serum creatinine exceeding 1.5 times the upper limit of normal, alanine aminotransferase or aspartate aminotransferase >= 2 times the upper limit of normal; 6. Those who are participating in clinical trials of other drugs, or those who have been out of clinical trials for less than 1 week; 7. Patients who fail to complete the drug treatment as prescribed by the doctor, cannot judge the efficacy, have poor compliance, or have incomplete information; 8. Patients with allergies (known to be allergic to the components of this medicine); 9. Pregnant, lactating patients or patients who intend to become pregnant; 10. History of neuropsychiatric disorders (epilepsy, depression, etc.); 11. Suspect or have a history of alcohol or drug abuse, or other diseases that reduce the possibility of enrolling or complicate enrollment, such as frequent changes in the working environment, which are likely to cause loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of joint tenderness;Morning stiffness time;DAS28 disease activity score;Evaluation of patient pain (rest pain);Doctor's evaluation of joint pain;Patients' self-evaluation of the current overall condition of the disease;Doctor's score of the patient's overall disease status;TCM syndrome score;Patient reported clinical outcome scale score;Health Assessment Questionnaire;Rheumatoid factor typing;Anti-cyclic citrullinated peptide antibody;C-reactive protein;ESR;Joint swelling number; | — |
Countries
China
Contacts
Public ContactChen Yanlin
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed