rheumatoid arthritis
Conditions
Interventions
matched group:Methotrexate tablet + qufeng analgesic capsule simulato
experimental group:Methotrexate tablet + qufeng analgesic capsule
Sponsors
Guang 'anmen Hospital, China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Criteria for classification of rheumatoid arthritis by the European Union against Rheumatism (EULAR) 2.TCM syndrome differentiation is cold and dampness obstruction syndrome 3.The age range is 18 to 75 years old 4.2.6=DAS28(CRP)=5.1 5.The daily dose of prednisone remained unchanged after enrollment 6.Before enrollment, traditional disease-improving antirheumatic drugs (DMARDs) such as Tripterygium wilfordii preparation were used, and the type was limited to 1, and had been treated at a stable dose for at least 4 weeks before enrollment, and the dose remained unchanged after enrollment 7.Subjects using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics to treat RA must have been treated at a steady dose for at least 1 week prior to enrollment, and the dose remained unchanged after enrollment Volunteer to participate in the trial and sign the informed consent
Exclusion criteria
Exclusion criteria: Patients who meet or are expected to meet any of the following criteria will be excluded from the study 1.Patients who had previously been treated with small molecule targeted drugs and biologics and had stopped treatment for less than 4 weeks 2.Qufeng Zhitong capsule was used in the past, and drug withdrawal was less than 4 weeks 3.Patients who had received intramuscular or intravenous glucocorticoids including adrenotropin within 4 weeks prior to enrollment 4.Pregnant and lactation women and recent birth plans 5.Patients with serious diseases of cardiovascular, brain, liver, lung, kidney, hematopoietic system and other important organs, acute and chronic infectious diseases, malignant tumors, and mental diseases 6.Patients with a white blood cell count of less than 3.0, or a hemoglobin of less than 90, or a platelet count of less than 100.0 on routine blood tests 7.Active liver disease or abnormal liver function,AST and ALT 1.2 times higher than the upper limit of normal value 8.Abnormal renal function, creatinine (Cr) 1.2 times higher than the upper limit of normal value 9.Patients with systemic lupus erythematosus scleroderma sjogren's syndrome and other clearly diagnosed autoimmune disease 10.There is a history of interstitial pulmonary change 11.Allergy to methotrexate tablet, qufeng analgesic capsule, any known ingredient 12.Are currently participating in another trial or have participated in another drug clinical trial within the last 2 months Had conditions that other investigators considered unacceptable for inclusion in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security Indicators(vital signs, physical examination, 12-lead electrocardiogram, chest x-ray, adverse events);Proportion of subjects meeting ACR20 remission criteria.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects meeting ACR50/70 standard;Average percentage of changes of CRP and ESR from baseline;The change value of health questionnaire (HAQ-DI) score from baseline;Changes of DAS28(CRP) score from baseline;Or the proportion of subjects who achieve clinical remission or maintain low disease activity DAS28(CRP)=3.2.;Changes of the reported clinical outcome (RA-PRO) score from baseline;Changes of visual analogue scale (VAS) from baseline;; | — |
Countries
China
Contacts
Public Contactjiangquan
Outcome results
None listed