Multicenter randomized double-blind clinical trial of Qufeng Zhitong Capsule combined with Methotrexate tablets in the treatment of rheumatoid arthritis

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: matched group:Methotrexate tablet + qufeng analgesic capsule simulato;experimental group:Methotrexate tablet + qufeng analgesic capsule; CONDITION: rheumatoid arthritis PRIMARY OUTCOME: security Indicators(vital signs, physical examination, 12‐lead electrocardiogram, chest x‐ray, adverse events);Proportion of subjects meeting ACR20 remission criteria.; SECONDARY OUTCOME: 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;; 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
Epistemonikos ID: 25b6a3b904ab8c861cd6d94e64344950d2b45c69
First added on: Aug 26, 2024