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Clinical study on the treatment of rheumatoid arthritis (cold dampness obstruction type) with Sanwu Jiaowan

Clinical study on the treatment of rheumatoid arthritis (cold dampness obstruction type) with Sanwu Jiaowan

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084989
Enrollment
Unknown
Registered
2024-05-29
Start date
2024-06-05
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

rheumatoid arthritis

Interventions

Test group:Sanwu Jiaowan+ Oral methotrexate
Control group:Oral methotrexate

Sponsors

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Active RA that meets the diagnostic criteria of Western medicine. 2. Meets the diagnostic criteria of traditional Chinese medicine for cold dampness obstruction and the dialectical differentiation of cold dampness obstruction syndrome. 3. Age range from 18 to 65 years old, regardless of gender. 4. DAS28 score>2.6. 5. No biological agents have been used in the past month. 6. Willing to cooperate with observation and follow-up for more than 12 weeks, willing to voluntarily cooperate with questionnaire surveys, routine examinations, and the execution of treatment plans. 7. Sign the informed consent form for clinical research.

Exclusion criteria

Exclusion criteria: (1) Individuals with other rheumatic and immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc; (2) Individuals with concomitant cardiovascular diseases (coronary heart disease, pulmonary heart disease, cardiomyopathy, etc.) and arrhythmia; (3) Individuals with elevated ALT/AST levels exceeding three times the normal value (>120 U/L), or with elevated creatinine levels exceeding 177umol/L and urea nitrogen levels exceeding 7.0mmol/L; (4) Severe diseases such as lung (interstitial fibrosis), gastrointestinal tract, kidney, hematopoietic system or tumors, or various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.); (5) Hormone dependence, long-term use of hormones; (6) Has contraindications and a history of allergies to experimental drugs; (7) Have a history of alcoholism, drug abuse, or neurological and psychiatric disorders (epilepsy, depression, etc.); (8) Pregnant or lactating women who have a recent birth plan; (9) Currently participating in clinical research on other drugs. (Note: Patients who meet any of the above criteria should be excluded and cannot be included in this trial.)

Design outcomes

Primary

MeasureTime frame
ESR;CRP;DAS28 Disease Activity Score;Traditional Chinese Medicine Syndrome Points;

Secondary

MeasureTime frame
rheumatoid factor;Anti cyclic citrulline peptide antibody;VAS scores;

Countries

China

Contacts

Public ContactLi Zhaofu

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine; Yunnan University of Traditional Chinese Medicine

lzf0817@126.com+86 131 8744 2840

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026