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The Stepped-Wedge Cluster Randomized Trial of Comprehensive Tibetan Medicine Bath Therapy for the Treatment of Rheumatoid Arthritis

Key Technologies in the Preparation of Tibetan Herbal Bath Solutions and a Stepped Wedge Cluster Randomized Trial for Rheumatoid Arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001384
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Rheumatoid Arthritis

Interventions

Sequence 1:Weeks1~2:Oral Tibetan medicine.Weeks3~4:Oral Tibetan medicine+Tibetan medicine bath therapy+Hor ma therapy+topical application therapy.Comprehensive Tibetan Medicine Bath Therapy:Oral Tibet

Sponsors

Tibet Autonomous Region Tibetan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for rheumatoid arthritis in Western medicine; (2) Meets the diagnostic criteria for (Changzhong) in Tibetan medicine; (3) Aged between 18 and 75 years old; (4) No use of systemic Western medications for rheumatoid arthritis in the past 3 months.

Exclusion criteria

Exclusion criteria: (1) Patients with other severe autoimmune diseases, such as systemic lupus erythematosus, Sjögren's syndrome, myositis, etc.; (2) Patients with skin lesions (including skin damage, infection, ulcers, etc.), infectious diseases, fever, debility, asthma, edema, coronary heart disease, acute cerebral hemorrhage, hypokalemia, acute cholecystitis, heart rate below 45 beats per minute, or alcohol allergy, who are not suitable for Tibetan herbal bath; (3) Patients with skin diseases or pustules who are not suitable for topical application; (4) Patients with C-reactive protein or erythrocyte sedimentation rate (ESR) more than three times above the upper limit of normal, or both C-reactive protein and ESR more than two times above the upper limit of normal; (5) Patients allergic to the drugs used in this study or patients with allergic constitution; (6) Patients with severe primary diseases of the heart, liver, kidney, brain, endocrine system, or hematopoietic system, malignant tumors, or mental disorders; (7) Pregnant women, breastfeeding women, or women planning pregnancy within three months; (8) Patients who have participated in or are currently participating in other interventional clinical trials within the past three months; (9) Other situations deemed unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
The 28-joint disease activity index, Disease Activity Score in 28 joints (DAS28), is calculated using C-reactive protein (CRP).;Patient's assessment of pain;

Secondary

MeasureTime frame
Disease Activity;The patient's overall assessment of disease activity;The doctor's overall assessment of disease activity.;Joint involvement and severity;Physical Functions and Disabilities;

Countries

China

Contacts

Public ContactTsering Samdrup

Tibet Autonomous Region Tibetan Hospital (Tibet Autonomous Region Research Institute of Tibetan Medicine)

sangzhu78@126.com13908919456

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026