NCT07129460

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are: Does Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia. Participants will: TakeBerberine or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.

Conditions

• Gastric Intestinal Metaplasia

Interventions

Type	Name	Description
DRUG	Berberine hydrochloride	Subjects will be instructed to take three tablets (300mg) of Berberine hydrochloride two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
DRUG	Placebo	Subjects will be instructed to take three tablets (300mg) of placebo two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2025-08-19
• Last updated: 2025-09-04