Weifuchun tablets versus folic acid to reverse gastric intestinal metaplasia
Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
This trial tries to see if taking Weifuchun tablets daily for six months can reverse gastric intestinal metaplasia in adults without Helicobacter pylori compared with daily folic acid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT06610266 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study enrolls adults aged 18–75 with OLGIM stage II–IV gastric intestinal metaplasia who are Helicobacter pylori–negative. Participants will take either Weifuchun tablets or folic acid every day for six months and visit the clinic about once every four weeks for exams and safety checks. Eligibility requires recent endoscopic and histopathologic confirmation of OLGIM stage II–IV, and investigators will compare changes in intestinal metaplasia and record any adverse events. Folic acid is used as the comparator in line with Chinese consensus recommendations for managing gastric precancerous conditions.
Who should consider this trial
Good fit: Adults 18–75 with OLGIM stage II–IV gastric intestinal metaplasia who are Helicobacter pylori–negative (including previously successfully eradicated) and able to take daily medication and attend monthly follow-up visits are the intended participants.
Not a fit: Patients with recent H. pylori infection, prior stomach surgery or malignancy, severe heart/renal/liver disease, pregnancy or breastfeeding, regular NSAID or statin use, substance or alcohol abuse within one year, severe mental illness, or who refuse drug treatment are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, Weifuchun could provide a non‑surgical treatment option to reduce or reverse precancerous gastric changes in H. pylori–negative patients.
How similar studies have performed: Some small trials and observational studies, largely from China, have suggested Weifuchun may improve chronic atrophic gastritis and related precancerous lesions, but high‑quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an
- Xijing hospital — Xi'an, China (Recruiting)
Study contacts
- Study coordinator: Yongquan Shi
- Email: shiyquan@fmmu.edu.cn
- Phone: 0086 + 02984771515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.