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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
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.
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.
The 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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