Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia

Официальное название

Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Обзор

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.

Вмешательства

• Препарат Berberine hydrochloride
  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.
• Препарат Placebo
  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.

Первичные конечные точки

• The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. [Срок оценки: From enrollment to the end of treatment at 6 months]
• The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (2)

• The regression rate of gastric atrophy based on OLGA stage in different groups. [Срок оценки: From enrollment to the end of treatment at 6 months]
• The progression rate of gastric atrophy based on OLGA stage in different groups. [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07129460 · KY20252248-F-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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