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RecruitingNCT06610266Updated Aug 6, 2026

Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

A Phase 4 interventional study of Weifuchun and Folic Acid in Gastric Intestinal Metaplasia, sponsored by Yongquan Shi. Recruiting at 9 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Yongquan Shi · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Intestinal Metaplasia

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03

In context

Metaplasia

45 studies on the registry are indexed under Metaplasia; 11 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 26 interventional studies indexed under Metaplasia.

Browse Metaplasia studies →

Lead sponsor

Yongquan Shi is the lead sponsor of 9 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 6 months.

  2. 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.

    Time frame: From enrollment to the end of treatment at 6 months.

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 6 months.

  2. 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.

    Time frame: From enrollment to the end of treatment at 6 months.

07

Study locations

9 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06610266
Lead sponsor
Yongquan Shi
Responsible party
Yongquan Shi (Professor, Xijing Hospital of Digestive Diseases) — Sponsor-investigator
First posted
Sep 24, 2024
Start date
Feb 28, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 6, 2026

Study contacts

Yongquan Shi
Contact
shiyquan@fmmu.edu.cn
0086 + 02984771515

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Weifuchun

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