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A real-world bidirectional cohort study on the influence and mechanism of the structure of the pathogenesis of blood stasis and heat on the transformation of the toxicity and efficacy of Tripterygium wilfordii in the treatment of rheumatoid arthritis

A real-world bidirectional cohort study on the influence and mechanism of the structure of the pathogenesis of blood stasis and heat on the transformation of the toxicity and efficacy of Tripterygium wilfordii in the treatment of rheumatoid arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002474
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-25
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

conventional therapy combined with Tripterygium treatment group:none

Sponsors

Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Diagnostic criteria: Meeting the classification criteria of the American College of Rheumatology in 1987 or the ACR/EULAR classification criteria in 2010. 2) Age range: 18 to 70 years old (including 18 and 70 years old). 3) Treatment plan: Conventional treatment; conventional treatment + Tripterygium wilfordii treatment. All treatment plans should have detailed information on drug names, dosages, frequencies, and treatment durations. 4) Informed consent: Voluntary participation in this study, with patients signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with insufficient data quality or missing key information were excluded. 2) Patients with incomplete follow-up information were excluded. 3) Patients for whom it was difficult to fully collect syndrome data and thus unable to conduct syndrome stratification. 4) Patients with a history of allergy to study drugs such as Tripterygium wilfordii. 5) Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, malignant tumors, mental disorders; pregnant or lactating women. 6) Patients with other rheumatic immune diseases that may affect the distribution of monocyte subtypes or the assessment of RA conditions. 7) Patients who participated in other clinical trials within the previous 3 months.

Design outcomes

Primary

MeasureTime frame
DAS28 score;ACR20-50-70;

Secondary

MeasureTime frame
HAQ score;Patient Global Assessment;Physician Global Assessment;Joint tenderness count;Joint swelling count;Pain VAS score;

Countries

China

Contacts

Public ContactZhe Feng

Nanjing University of Chinese Medicine

i7seven@163.com13584046875

Outcome results

None listed

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