Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
试验速览
- 阶段
- 1 期
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change of Main Symptom Score
研究概览
简要总结
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.
详细描述
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metting the diagnostic criteria of functional dyspepsia in Rome IV.
- •The subjects were informed, and the subjects voluntarily signed informed consent.
- •The subjects have reading ability.
排除标准
- •Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
- •Patients with Hp infection positive.
- •Patients with gastroesophageal reflux disease.
- •Patients with digestive system organic lesions.
- •The patient had a history of stomach or abdominal surgery.
- •Patients had taken the relevant drugs in the past 2 weeks.
- •Patients suffering from severe illness affecting survival.
- •Pregnant or lactating women.
- •Participating in clinical trials of other drugs.
- •Long term using of sedative hypnotics.
- •Suspected or true alcohol, drug abuse history.
研究组 & 干预措施
Qizhi Weitong Granules Group
Patients in this group will take Qizhi Weitong Granules for 8 weeks.
干预措施: Qizhi Weitong Granules (Drug)
Mosapride Citrate Tablets Group
Patients in this group will take mosapride citrate tablets for 8 weeks.
干预措施: Mosapride Citrate Tablets (Drug)
结局指标
主要结局
Change of Main Symptom Score
时间窗: The score will be assessed at baseline and 2 week, 4 week, 6 week.
The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.
次要结局
- Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale(The score will be assessed at baseline and 2 week, 4 week, 6 week.)