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RECRUITING
NCT06610266
PHASE4

Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

Sponsor: Yongquan Shi

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate the efficacy and safety of Weifuchun tablet in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. The main questions it aims to answer are: Does Weifuchun tablet promote the regression of gastric intestinal metaplasia in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Weifuchun tablet? Researchers will compare the effectiveness of Weifuchun tablet in treating gastric intestinal metaplasia with that of folic acid, as suggested by the Chinese consensus on management of gastric epithelial precancerous conditions and lesions (2020). Participants will: Take Weifuchun tablets or folic acid every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.

Official title: Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-02-28

Completion Date

2027-12-31

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

Weifuchun

Subjects will be instructed to take four tablets (1400mg) of Weifuchun three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

DRUG

Folic Acid

Subjects will be instructed to take one tablet (5mg) of folic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

Locations (9)

Ankang Central Hospital

Ankang, China

Tongchuan People's Hospital

Tongchuan, China

Weinan Central Hospital

Weinan, China

The 986th Hospital of Air Force Medical University

Xi'an, China

Xijing hospital

Xi'an, China

Xi'an Central Hospital

Xi'an, China

Xi'an Honghui Hospital

Xi'an, China

Xunyang People's Hospital

Xuchang, China

Affiliated Hospital of Yan'an University

Yanan, China