Rheumatoid Arthritis
Conditions
Interventions
Control Group:Routine treatment + placebo patch
Experimental Group:Routine treatment + Jiawei Shaogang Fuzi Decoction for external application
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the 2010 American College of Rheumatology (ACR) and European Alliance Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis (RA); (2) Meets the diagnostic criteria for the TCM syndrome of cold-damp obstruction as outlined in the 2017 "Guidelines for the Integrated Diagnosis and Treatment of Rheumatoid Arthritis" issued by the Rheumatism Branch of the Chinese Association of Traditional Chinese Medicine; (3) Aged between 18 and 75 years; (4) RA is in an active phase (DAS28 = 2.6); (5) Significant involvement of hand joints: Confirmed by ultrasound to have synovitis in the metacarpophalangeal joints, proximal interphalangeal joints, and/or wrist joints; (6) Has received treatment with disease-modifying antirheumatic drugs (DMARDs) prior to enrollment, with the dosage stabilized for at least 1 month before entering the study and maintained unchanged during the trial; (7) Has received treatment with TCM decoctions or Chinese patent medicines prior to enrollment, with the main formula dosage of the decoction and the types of Chinese patent medicines fixed, and stabilized for at least 2 weeks; if not taking any, must have abstained for at least 1 week; (8) The participant agrees and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) History of allergy to therapeutic drugs or skin ulcers; (2) Pregnant or breastfeeding women; (3) Individuals who have orally ingested or received intra-articular injections of glucocorticoids within the past month; (4) Patients with other connective tissue diseases, such as systemic lupus erythematosus, Sjögren's syndrome, or severe knee osteoarthritis; (5) Patients with severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems, or those with mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28-CRP/ESR scores before and after treatment;The first time of relief from joint pain and joint swelling.;Grading Assessment of Synovitis and Proliferation in Joint Ultrasound Before and After Treatment;Morning stiffness duration at weeks 0, 2, and 4 of treatment.;Health Assessment Questionnaire Disability Index (HAQ-DI score), Rheumatoid Arthritis Quality of Life Scale (RA-QoL score);Before and after treatment blood inflammatory markers; | — |
Countries
China
Contacts
Public Contactxiujuan hou
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed