rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 16-70 years; 2. Meet the diagnostic criteria of ACR in 1987 or ACR/EULAR in 2010, with a course of disease <= 3 years; 3. Comply with the diagnostic criteria of TCM syndrome of cold-dampness obstruction or damp-heat obstruction in the "Traditional Chinese Medicine Diagnosis and Efficacy Criteria for Diseases and Syndrome"; 4. RA disease activity DAS28 <= 5.2; 5. Patients who did not receive treatment, or who only took methotrexate; 6. Voluntarily participate and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other rheumatism or severe pain caused by other diseases (such as diabetic pain or post-herpetic neuralgia); 2. Joint dysfunction, and the X-ray score of both wrists is grade IV; 3. Associated with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases, or restless legs syndrome Symptoms and other peripheral nerve diseases; 4. Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the upper limit of normal), kidney (Cr < 60mL/min) and other important organ dysfunction or blood system diseases; 5. Pregnant or breastfeeding women or women and men who plan to become pregnant within the next 6 months; women of childbearing age who are unable or unwilling to take adequate contraception during the trial or within 1 month after the last dose or their spouses unwilling to take contraception measure; 6. Those who have participated in other clinical drug observations or are receiving other therapeutic drugs in the last 3 months; 7. Those who have adverse reactions to the ingredients of traditional Chinese medicine or methotrexate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score (DAS) 28; | — |
Secondary
| Measure | Time frame |
|---|---|
| FS-14 Fatigue Score;Pain Visual Analogue Scale Score;TCM Syndrome Score; | — |
Countries
China
Contacts
China-Japan Friendship Hospital