RecruitingPhase 4NCT05540938

Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis


Sponsor

China-Japan Friendship Hospital

Enrollment

340 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the long-term effectiveness and safety of WangBi Granules — a traditional Chinese herbal medicine — as an add-on treatment for people with rheumatoid arthritis (RA) that is mildly active despite standard treatment. Researchers want to see whether this herbal supplement can improve joint symptoms when added to the existing medication regimen. **You may be eligible if:** - You are 18–75 years old - You have been diagnosed with rheumatoid arthritis (RA) using standard diagnostic criteria - Your RA is mildly active (DAS28 score between 2.6 and 3.2) - You have been on a stable dose of methotrexate and tofacitinib (a JAK inhibitor) for at least 4 weeks - Your traditional Chinese medicine diagnosis aligns with a specific pattern (kidney deficiency with dampness and stagnation) **You may NOT be eligible if:** - You are on other immunosuppressive drugs (beyond the standard ones listed) - You have serious infections, liver disease, or kidney disease - You have used WangBi Granules previously - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWangbi granules

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.

DRUGWangbi granules simulant

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.


Locations(1)

China-Japan Friendship Hospital

Beijing, China

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NCT05540938


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