Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Yongquan Shi
shiyquan@fmmu.edu.cn
0086 + 02984771515
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 400
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Yongquan Shi

This content was sourced from clinicaltrials.gov