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A Multicenter, Prospective, Observational Real-World Study of Bushen Tongluo Decoction for the Treatment of Rheumatoid Arthritis

A Multicenter, Prospective, Observational Real-World Study of Bushen Tongluo Decoction for the Treatment of Rheumatoid Arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000054
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-05-29

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 group:Methotrexate+Apremilast
Bushen Tongluo Decoction Group:Bushen Tongluo Decoction + Methotrexate+Apremilast

Sponsors

The Affiliated Hospital of Gansu Traditional Medicine University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meets the aforementioned Western medical diagnosis, traditional Chinese disease classification, and syndrome diagnosis. (2) Age range between 35 and 60 years. (3) Classified with joint function levels I, II, or III, and hand X-ray staging falls under stages I, II, or III. (4) RA disease activity is mild to moderate. (5) Has not recently taken or been administered non-steroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs (DMARDs), biologics, glucocorticoids, or similar medications intended to alleviate symptoms or improve rheumatoid arthritis condition.

Exclusion criteria

Exclusion criteria: (1) Patients who do not meet the diagnostic criteria. (2) Patients who have used glucocorticoid medications continuously for more than one month in the last six months (such as oral prednisone, methylprednisolone, or intravenous methylprednisolone). (3) Patients with concomitant other rheumatic diseases. (4) Patients who have taken medications in the past year that promote bone formation or absorption, such as calcium supplements, calcitriol, or teriparatide. (5) Patients with acute cardiovascular or cerebrovascular diseases. (6) Patients with significant concurrent systemic diseases, severe trauma, planned surgery, or severe infections. (7) Patients with a history of drug abuse, allergies to the medications used in this study, or a history of mental illness. (8) Women who are pregnant, breastfeeding, or in the preconception period.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Pain Scale (VAS scale);TCM symptom score;adverse reaction;

Secondary

MeasureTime frame
Acute phase reactants;bone mineral density test;appraisal of life quality;imageological examination;

Countries

China

Contacts

Public ContactGang Wang

The Affiliated Hospital of Gansu Traditional Medicine University

wangg_gtmu@126.com18298325636

Outcome results

None listed

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