NCT02460601已完成4 期
The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
Wuhan Union Hospital, China0 个研究点目标入组 400 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- symptom severity score
研究概览
简要总结
The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.
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
- Double (Participant, Investigator)
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
- •patient with written ICF signed
- •patient with functional dyspepsia diagnosed by the Rome III criteria
- •age between 18y and 65y;male or female.
- •patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital
- •patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital
- •patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center
- •patient with symptoms of only one subtype of functional dyspepsia
排除标准
- •history of abdominal surgery;
- •take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion
- •suffering from hepatobiliary and pancreatic diseases with B ultrasound
- •suffering from high blood pressure and uncontroled hypertension
- •diabetes mellitus
- •have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus
- •severe mental disorders
- •pregnant women, breastfeeding women or those who plan to become pregnant
- •allergy to Qizhiweitong particle
- •have symptoms of both subtypes of functional dyspepsia
研究组 & 干预措施
Qizhiweitong granule
Experimental
2.5g/time,tid,oral administration,6 weeks
干预措施: Qizhiweitong granule (Drug)
Placebo
Placebo Comparator
2.5g/time,tid,oral administration,6 weeks
干预措施: Qizhiweitong granule (Drug)
结局指标
主要结局
symptom severity score
时间窗: 3 days
次要结局
未报告次要终点
研究者
Zhongcheng Duan
Professor
Wuhan Union Hospital, China
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