Study of Weifuchun Tablet Versus Folic Acid for Treating Gastric Intestinal Metaplasia in Adults Without Helicobacter pylori Infection

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Weifuchun tablet in treating gastric intestinal metaplasia in adults who do not have Helicobacter pylori infection. The study aims to determine whether Weifuchun tablet can promote the regression of this condition compared to folic acid, following guidelines from the Chinese consensus on managing gastric precancerous conditions. It is a Phase 4, open-label, randomized controlled trial involving adults aged 18 to 75 years old. Participants are randomly assigned to one of two groups one group takes Weifuchun tablets at a dose of 1400 mg three times daily, while the other group takes folic acid tablets at 5 mg three times daily. Both treatments are taken orally every day for 6 months. Participants visit the clinic every 4 weeks for checkups, symptom evaluation, and to receive their medication supply. During the study, participants undergo regular assessments including upper gastrointestinal endoscopy and histopathological examinations to monitor the regression or progression of gastric intestinal metaplasia and gastric atrophy based on OLGIM and OLGA stages. Researchers measure outcomes from enrollment to the end of the 6-month treatment. Safety and side effects are also monitored throughout the trial, which lasts for the full 6 months of treatment.

Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia