ITMCTR2000004204尚未招募4 期
The randomized double-blind double-simulation and parallel-controlled clinical trial study on the efficacy and safety of Weifuchuni Capsule in the treatment of chronic atrophic gastritis
The First Affiliated Hospital of Zhejiang University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •1. Patients meeting the diagnostic criteria of chronic atrophic gastritis (Olga stage II and above);
- •2. Patients aged from 18 to 65 years old (including 18 and 65 years old) are not limited in gender;
- •3. The patients who voluntarily participate in this clinical trial should have informed consent and sign the informed consent form.
排除标准
- •1. Patients with peptic ulcer, gastroesophageal reflux disease and other diseases requiring PPI treatment;
- •2. Patients with high grade intraepithelial neoplasia of gastric mucosa or suspected malignant change by pathological diagnosis;
- •3. HP positive patients and those who have received anti HP treatment and related treatment in the past four weeks;
- •4. Drug history: Taking the following drugs within one month before specimen collection:
- •(1) Antibiotics (oral, intramuscular and intravenous);
- •(2) Microecological agents (probiotics, prebiotics, synbiotics, etc.);
- •(3) Various drugs (proton pump inhibitors and H2 receptor antagonists, etc.) that inhibit gastric acid secretion;
- •(4) Cytokines, immunosuppressants and cytotoxic agents, etc;
- •(5) Hormones;
- •(6) Other drugs affecting gastric flora;
- •5. Patients with abnormal renal function and clinical significance, liver function ALT >= 2 times the upper limit of normal reference value;
- •6. Patients with serious primary heart, liver, kidney, lung, blood and nervous system diseases;
- •7. Patients with mental retardation or psychosis;
- •8. Patients with suspected or true history of alcohol or drug abuse;
- •9. Pregnant and lactating women or women and men with family planning within one year;
- •10. Patients with known or suspected allergic history to the test drug and its excipients;
- •11. Patients who have participated in other clinical trials in recent 3 months;
- •12. Patients considered unsuitable by the researchers to participate in this clinical trial.
研究者
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