Gastric Intestinal Metaplasia
Conditions
Brief summary
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins/or Metformin. * a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor. * a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study. * breastfeeding or pregnancy. * a history of substance abuse or alcohol abuse within the past one year. * patients with severe mental illness. * refusal to undergo drug treatment. * refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The regression rate of gastric atrophy based on OLGA stage in different groups. | From enrollment to the end of treatment at 6 months | Regression was defined as a OLGA stage decreased at least one grade. |
| The progression rate of gastric atrophy based on OLGA stage in different groups. | From enrollment to the end of treatment at 6 months | Progression was defined as a OLGA stage increased at least one grade. |
Contacts
Primary ContactYongquan Shi Shi
Outcome results
None listed