NCT01863966Unknown不适用
Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline achalasia symptom score at 1 month
研究概览
简要总结
From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.
详细描述
- Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
- Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
- If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •achalasia patients diagnosed by endoscopy, barium esophagram and manometry
排除标准
- •could not drink water
- •poor compliance
- •severe comorbidities
- •esophageal stenosis secondary to erosions and cancer
结局指标
主要结局
Change from baseline achalasia symptom score at 1 month
时间窗: baseline and 1 month
Dysphagia, Regurgitation and Chest Pain scores
次要结局
- Number of patients with adverse effects(Week 1)
- Change from baseline in barium esophagram at 1 year(baseline and 1 year)
- Endoscopy at 1 year(year 1)
- Pneumatic dilation rate and relative efficacy(any time)
- Change from baseline in achalasia symptom score at 1 year(baseline and 1 year)
- Change from baseline achalasia symptom scores at 5 years(baseline and 5 years)
- Change from baseline in barium esophagram at 5 years(baseline and 5 years)
- Endoscopy at 5 years(year 5)
研究者
研究点 (2)
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