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A randomized controlled trial of Tripterygium wilfordii for improving fatigue in rheumatoid arthritis based on Zelen design

Establishment of prediction model for fatigue degree of rheumatoid arthritis and a pilot study of Tripterygium wilfordii

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002597
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Rheumatoid arthritis

Interventions

Experimental Group:Tripterygium glycosides tablets, 20mg each time, three times a day, orally
Control group:Methotrexate tablets, 10mg each time, once a week, orally.

Sponsors

Beijing University of Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 72 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 72 years old, gender not limited. 2) 2.6 points < DAS28 score (active disease stage). 3) No hormone therapy was received within 12 weeks (including 12 weeks) before enrollment. 4) Those who have signed the informed consent form for clinical research and are willing to cooperate.

Exclusion criteria

Exclusion criteria: 1)Combined with other rheumatic immune diseases that may affect fatigue assessment, including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, systemic scleroderma, fibromyalgia syndrome, tensor spondylitis, etc.2)Patients who have been diagnosed with fatigue syndrome;3)Combined with severe respiratory system diseases, cardiovascular and cerebrovascular diseases, etc.4)Those with known mental disorders or allergic constitutions; 5) Suffering from any type of active malignant tumor or having a malignant tumor disease;6)Suffering from any acute or chronic active infectious disease;7)Patients who are preparing for pregnancy, pregnant or breastfeeding;8)Patients allergic to Tripterygium glycosides tablets;9)The researcher judged that it was not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Degree of fatigue;

Secondary

MeasureTime frame
Response rate assessed by disease activity (predominantly DAS28-CRP);Fatigue Scale -14;ACR20 remission rate;Pain VAS score;Interleukin-6;Tumor necrosis factor-a;

Countries

China

Contacts

Public ContactLV Liu

Dongzhimen Hospital of Beijing University of Chinese Medicine

984193184@qq.com13212007957

Outcome results

None listed

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