rheumatoid arthritis
Conditions
Interventions
Western medicine group (Methotrexate tablets):None
Chinese medicine group (Shi-Er-Qing-Bi-Tang + Methotrexate Tablets):None
Sponsors
Wangjing Hospital, China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets 2010 ACR/EULAR criteria for RA classification; (2) 3.2 < DAS28 < 5.1; (3) Chinese medicine diagnosis belongs to RA patients consistent with the syndrome of damp-heat paralysis and obstruction; (4) Duration of disease = 24 months; (5) Age between 18 and 65 years old, without gender restrictions; (6) The patients were informed and agreed to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Overlapping other rheumatic diseases such as systemic lupus erythematosus, ankylosing spondylitis, severe osteoporosis, recent joint injuries, and hormone-induced ischemic necrosis of the femoral head; (2) Serious diseases, including, but not limited to, the following: diabetes mellitus with fasting >8 mmol-L-1 after drug intervention and >13 mmol-L-1 2 h after meal, hypertension grade 2 or higher, cardiovascular and cerebrovascular diseases, history of hematologic diseases, systemic infections or contagious diseases, bleeding tendency, or on anticoagulant therapy, aspirin asthma (asthma attacks caused by non-steroidal anti-inflammatory drugs), or asthma attacks caused by non-steroidal anti-inflammatory drugs (NSAIDs). asthma attacks caused by non-steroidal anti-inflammatory drugs) or a history of aspirin-induced asthma, mental illness, and malignant tumors; (3) Those with interstitial lung lesions or recent untreated lung infections; (4) Those with a history of recent untreated acute liver disease or chronic liver disease or significant hepatic or renal dysfunction ( ALT or AST > 1.5 times the upper limit of normal; Cr > upper limit of normal); (5) Those who received biological agent treatment within 3 months before enrollment; (6) Those with a suspected or confirmed history of alcohol or drug abuse, as well as allergies, or known hypersensitivity to the test drug; (7) Women preparing for pregnancy, pregnant or breastfeeding; (8) Those who are participating or will participate in another clinical trial within 3 months; (9) Other patients deemed by the clinician to be unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 Mitigation rate;DAS28 Low activity rate;DAS28;EULAR Response Standard; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Disease Activity Index (CDAI);Simplified Disease Activity Index (SDAI);Visual analog score (VAS) for pain;Patient-Generated Subjective Global Assessment(PGA);physician'sglobal assessment of disease activity(MDGA);ACR mitigation standards (ACR20/50/70);Survival Quality Scale (SF36);Health Assessment Questionnaire Disability Index (HAQ-DI);Chinese Medicine Symptom Score;Complete Blood Count + CRP; | — |
Countries
China
Contacts
Public ContactWei Cao
Wangjing Hospital, China Academy of Traditional Chinese Medicine
Outcome results
None listed