Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Intestinal Metaplasia
• Intervention / Treatment: Drug: Weifuchun; Drug: Folic Acid

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yongquan Shi; Phone Number: 0086 + 02984771515; Email: shiyquan@fmmu.edu.cn

Study Locations

• China
  • Xi'an, China, 710032
    • Recruiting
    • Xijing Hospital
    • Contact: Yongquan Shi Shi; Phone Number: 029-84771515; Email: shiyquan@fmmu.edu.cn
    • Contact: Email: shiyquan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients aged from 18 to 75 years old.
• patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
• patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.

Exclusion Criteria:

• a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
• a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.
• a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.
• breastfeeding or pregnancy.
• a history of substance abuse or alcohol abuse within the past one year.
• patients with severe mental illness.
• refusal to undergo drug treatment.
• refusal to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Weifuchun tablet group; Patients in the Weifuchun tablet group will receive oral Weifuchun tablet at a dosage of 1400 mg three times daily for 6 months.	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.
Active Comparator: The folic acid group; Patients in the folic acid group will receive oral folic acid at a dosage of 5 mg three times daily for 6 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.	Regression was defined as a OLGIM stage decreased at least one grade.	From enrollment to the end of treatment at 6 months.
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.	Progression was defined as a OLGIM stage increased at least one grade.	From enrollment to the end of treatment at 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The regression rate of gastric atrophy based on OLGA stage in different groups.	Regression was defined as a OLGA stage decreased at least one grade.	From enrollment to the end of treatment at 6 months.
The progression rate of gastric atrophy based on OLGA stage in different groups.	Progression was defined as a OLGA stage increased at least one grade.	From enrollment to the end of treatment at 6 months.

Collaborators and Investigators

• Sponsor: Yongquan Shi

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Physiological Effects of Drugs; Micronutrients; Vitamin B Complex; Vitamins; Hematinics; Folic Acid
• Other Study ID Numbers: KY20242224-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No