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Clinical Cohort and Therapeutic Efficacy Evaluation Study on the Treatment of Rheumatoid Arthritis with Integrated Traditional Chinese and Western Medicine

Clinical Cohort and Therapeutic Efficacy Evaluation Study on the Treatment of Rheumatoid Arthritis with Integrated Traditional Chinese and Western Medicine

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000925
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

Sponsors

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

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

MeasureTime frame
Disease Activity Score 28 - Erythrocyte Sedimentation Rate;

Secondary

MeasureTime 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

Public ContactHe Dongyi

Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

dongyihe@medmail.com.cn15800300800

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026