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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Berberine group | Experimental | Patients in the Berberine group will receive oral Berberine hydrochloride at a dosage of 300 mg two times daily for 6 months |
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| The placebo group | Placebo Comparator | Patients in the placebo group will receive oral placebo at a dosage of 300 mg two times daily for 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| The progression rate of gastric atrophy based on OLGA stage in different groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi Shi | Contact | 029-84771515 | shiyquan@fmmu.edu.cn |
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| Placebo | Drug | 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. |
|
Progression was defined as a OLGA stage increased at least one grade. |
| From enrollment to the end of treatment at 6 months |