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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age 18-75 years.

• Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.

• Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.

• Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.

• Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.

• Voluntary participation and signed written informed consent.

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Zihan Wang, Dr
wzhbucm@163.com
+8618810902100
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 340
Treatments
Experimental: treatment group
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Active_comparator: control group
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Related Therapeutic Areas
Sponsors
Collaborators: Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Southwest Hospital, China, The Second Affiliated Hospital of Zhejiang Chinese Medical University, The 980th Hospital of PLA Joint Logistics Support Force
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov

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