Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

Weifuchun: 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.

Folic Acid: 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.

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.

Eligibility

Primary outcome measure(s)

• The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. — From enrollment to the end of treatment at 6 months.
  Regression was defined as a OLGIM stage decreased at least one grade.
• The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. — From enrollment to the end of treatment at 6 months.
  Progression was defined as a OLGIM stage increased at least one grade.

Trial sites (9)

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