Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Weifuchun, Folic Acid.
- Кому может быть актуально
- Состояния в реестре: Gastric Intestinal Metaplasia. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
Обзор
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.
Вмешательства
- Препарат Weifuchun
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. - Препарат Folic Acid
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.
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.
- 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
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 9 центров
- Ankang Central Hospital — Ankang
- Tongchuan People's Hospital — Tongchuan
- Weinan Central Hospital — Weinan
- The 986th Hospital of Air Force Medical University — Сиань
- Xijing hospital — Сиань
- Xi'an Central Hospital — Сиань
- Xi'an Honghui Hospital — Сиань
- Xunyang People's Hospital — Xuchang
- … и ещё 1 центр
Идентификаторы
NCT: NCT06610266 · KY20242224-F-1