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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
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.
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.
Xijing hospital
Xi'an, China
RECRUITINGThe regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Regression was defined as a OLGIM stage decreased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months.
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Progression was defined as a OLGIM stage increased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months.
The regression rate of gastric atrophy based on OLGA stage in different groups.
Regression was defined as a OLGA stage decreased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months.
The progression rate of gastric atrophy based on OLGA stage in different groups.
Progression was defined as a OLGA stage increased at least one grade.
Time frame: From enrollment to the end of treatment at 6 months.
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