Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pCLE score
研究概览
简要总结
Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.
详细描述
This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Consecutive outpatients aged 18 to 75 years old.
- •FD patients defined by the Rome III classification.
- •Willing to choose pCLE and no organic diseases.
排除标准
- •Severe liver, heart, or kidney diseases.
- •Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
- •Pregnant or breastfeeding women.
- •Inability to give informed consent.
- •Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.
研究组 & 干预措施
postprandial distress syndrome (PDS)
FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS).
pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
干预措施: pCLE examination (Device)
postprandial distress syndrome (PDS)
FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS).
pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
干预措施: Puyuanhewei (Drug)
epigastric pain syndrome (EPS)
pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
干预措施: pCLE examination (Device)
epigastric pain syndrome (EPS)
pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
干预措施: Puyuanhewei (Drug)
结局指标
主要结局
pCLE score
时间窗: within 1 hour after pCLE examination
Used to assess the gastric barrier dysfunction of FD patients
次要结局
- Leeds dyspepsia questionaire(baseline and 4th week)
- Main dyspepsia symptom score(baseline and 4th weeks)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University