NCT05540938

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2022-09-15
• Last updated: 2025-01-20

Locations

1 site across 1 country: China