Evaluation of the efficacy and safety of Wenjing Tongluo Formula in difficult-to-treat rheumatoid arthritis

Evaluation of the efficacy of Wenjing Tongluo Formula in difficult-to-treat rheumatoid arthritis and the mechanism of immune homeostasis-metabolic regulation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400081463

Enrollment

Unknown

Registered

2024-03-01

Start date

2024-03-01

Completion date

Unknown

Last updated

2024-03-04

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:Conventional treatment + Wenjing Tongluo Formula and additional subtractions were made according to the diagnosis.

Control Group:Conventional treatment

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meet the 2010 ACR and EULAR RA classification criteria; 2) Meet the Chinese medicine diagnostic criteria for cold-dampness obstruction syndrome; 3) Diagnosis of difficult-to-treat rheumatoid arthritis (? history of drug treatment failure: a. treatment failure after 3-6 months of two csDMARDs combined with one bDMARD or tsDMARD; b. inability to reduce glucocorticoids (GC) therapy (GCs = 10mg of prednisone or equivalent); ? assessment of disease activity : DAS28-ESR > 3.2; ? Simultaneous consideration of fatigue, foot arthritis, imaging progression, extra-articular manifestations and co-morbidities) ; 4) Treatment for at least one year according to current treatment criteria; 5) 3.2 < DAS28-ESR = 5.1; 6) Age 18-70 years; 7) Those who volunteered to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with severe lesions of brain, kidney and other major organs,cancer and mental illness. 2) Comorbidities with other rheumatic diseases such as systemic lupus erythematosus and Sjogren syndrome; 3) Pregnant or lactating women; 4) Those with suspected or confirmed history of alcohol and drug abuse; 5) Allergy, and those who are allergic to the known components of the study drug, any excipients.

Design outcomes

Primary

Measure	Time frame
DAS28 rating;visual analogue scale;	—

Secondary

Measure	Time frame
Effective rate of TCM syndromes;Clinical disease activity index;Simplified disease activity index;Patient global assessment;Physician (MD) global assessment of disease activity;Medical Outcomes Study Short-Form 36;Health Assessment Questionnaire;The Functional Assessment of Chronic Illness Therapy – Fatigue Scale;	—

Countries

China

Contacts

Public ContactHou Xiujuan

Department of Rheumatology, Dongfang Hospital, Beijing University of Chinese Medicine,Beijing, China

houxiujuan2008@163.com+86 67689721

Outcome results

None listed

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