Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

NCT ID: NCT06610266

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Weifuchun

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Folic Acid

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongquan Shi

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xijing hospital

Xi'an, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongquan Shi

Role: CONTACT

shiyquan@fmmu.edu.cn

0086 + 02984771515

Facility Contacts

Yongquan Shi Shi

Role: primary

shiyquan@fmmu.edu.cn

029-84771515

Role: backup

shiyquan@fmmu.edu.cn

Other Identifiers

KY20242224-F-1

Identifier Type: -

Identifier Source: org_study_id