Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Pathological improvement rate of gastric mucosa
研究概览
简要总结
To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •The age is 18-75 years old, regardless of gender;
- •Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
- •Sign the informed consent form.
排除标准
- •Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
- •Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
- •Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
- •Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
- •Patients with chronic liver and kidney dysfunction before treatment, including ALT > 1.5 times the upper limit of normal value, blood creatinine (CR) > 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
- •Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities);
- •The description of self symptoms is unclear or the investigation is not the author;
- •Have a history of alcohol abuse;
- •Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug);
- •Pregnant or lactating women;
- •According to the judgment of the researcher, other reasons should not be selected.
研究组 & 干预措施
Manpixiao treatment group
A traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks
干预措施: Manpixiao (Drug)
Active comparator
Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions.
干预措施: Active comparator (Drug)
结局指标
主要结局
Pathological improvement rate of gastric mucosa
时间窗: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy
次要结局
- Score of main symptoms of stomach system(They were evaluated on the day of enrollment and the day of the end of the treatment process)
- Gastric mucosal status under gastroscope(The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.)
研究者
Dr. Xia Ding
Professor
Beijing University of Chinese Medicine