Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the 1987 ACR Classification Criteria for RA and the 2010 ACR/EULAR Classification Criteria for RA; 2) Meet the 2020 ACR/EULAR Definition of Difficult-to-Treat Rheumatoid Arthritis (D2T RA); 3) For interstitial lung disease, meet the diagnostic criteria established by the American Thoracic Society/European Respiratory Society in 2000; 4) TCM syndrome differentiation criteria refer to the Guidelines for the Diagnosis and Treatment of Rheumatoid Arthritis with Integrated Disease and Syndrome by the China Association of Chinese Medicine, the Guiding Principles for Clinical Research of New Chinese Medicines by the National Medical Products Administration, and the Criteria for Diagnosis and Therapeutic Effect of TCM Diseases and Syndromes by the Institute of Clinical Basic Medicine of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences; 5) Receive Traditional Chinese Medicine treatment (based on the TCM syndrome differentiation criteria, using modified formulas corresponding to the RA syndrome type); 6) Age = 18 years; 7) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals with severe organ dysfunction or mental illness; 2) Pregnant or breastfeeding women; 3) Individuals with a history of malignant tumors; 4) Patients with severe or poorly controlled hypertension, diabetes, or cardiac insufficiency; 5) Patients with other rheumatic immune diseases such as systemic lupus erythematosus or dermatomyositis, or patients with other concomitant respiratory diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score 28 - Erythrocyte Sedimentation Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology 20%/50%/70% improvement criteria;Clinical Disease Activity Index;Simplified Disease Activity Index;Traditional Chinese Medicine Syndrome Score;Health Assessment Questionnaire Score;Forced Vital Capacity;Diffusing Capacity of the Lungs for Carbon Monoxide; | — |
Countries
People's Republic of China
Contacts
Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine