Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The Weifuchun tablet group
Patients in the Weifuchun tablet group will receive oral Weifuchun tablet at a dosage of 1400 mg three times daily for 6 months.
干预措施: Weifuchun (Drug)
The folic acid group
Patients in the folic acid group will receive oral folic acid at a dosage of 5 mg three times daily for 6 months.
干预措施: Folic Acid (Drug)
结局指标
主要结局
The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
时间窗: 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.
时间窗: From enrollment to the end of treatment at 6 months.
Progression was defined as a OLGIM stage increased at least one grade.
次要结局
- The progression rate of gastric atrophy based on OLGA stage in different groups.(From enrollment to the end of treatment at 6 months.)
- The regression rate of gastric atrophy based on OLGA stage in different groups.(From enrollment to the end of treatment at 6 months.)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases