A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
研究概览
简要总结
This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
详细描述
This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Roman III criteria
- •One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety
- •No organic lesion
- •Helicobacter pylori infection
排除标准
- •has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
- •had a surgery that might affect gastrointestinal motility
研究组 & 干预措施
H.Pylori eradication therapy
A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
干预措施: A-Cilin®, Clari® and Pantoline® (Drug)
Motilitone®
30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)
干预措施: Motilitone® (Drug)
结局指标
主要结局
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
时间窗: 12 weeks
5-Likert scale 1. deteriorated 2. not changed 3. moderately improved 4. markedly improved 5. symptom-free
次要结局
- Volunteer global assessment by using 5-Likert scale(6 weeks)
- The improvement rate of 4 types of dyspepsia symptoms(12 weeks)
- Assessment of NDI-K Quality of Life(6,12 weeks)
- The change of each score and total score of dyspeptic symptoms(6, 12 weeks)
- The proportion of the patients who answered "yes for the question about symptom improvement(6, 12 weeks)
研究者
Jae Gyu Kim
Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine