Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

NCT06610266 | Recruiting Phase 4

• 1 other identifier: KY20242224-F-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The regression rate of gastric atrophy based on OLGA stage in different groups.

  From enrollment to the end of treatment at 6 months.

• The progression rate of gastric atrophy based on OLGA stage in different groups.

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

The Weifuchun tablet group

EXPERIMENTAL

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

The folic acid group

ACTIVE COMPARATOR

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

Interventions

Weifuchun DRUG

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.

The Weifuchun tablet group

Folic Acid DRUG

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.

The folic acid group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (1)

Xijing hospital

Xi'an, 710032, China

RECRUITING

MeSH Terms

Interventions

weifuchun; Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yongquan Shi

CONTACT

0086 + 02984771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)