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

NCT05540938 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-01-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    collaborator OTHER

  • The 980th Hospital of PLA Joint Logistics Support Force

    collaborator UNKNOWN

  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

    collaborator OTHER

  • Southwest Hospital, China

    collaborator OTHER

  • China-Japan Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540938 on ClinicalTrials.gov