NCT00160290终止4 期
An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovate on the Quality of Life of Patients With Hard Stools and Hemorrhoids or Anal Fissure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 8
- 主要终点
- Quality of life of patients with hard stools and hemorrhoids or anal fissure
研究概览
简要总结
To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.
排除标准
- •Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.
研究组 & 干预措施
B
Active Comparator
Plantago Group
干预措施: Plantago ovata (Drug)
A
Experimental
Lactulose Group
干预措施: Lactulose (Drug)
结局指标
主要结局
Quality of life of patients with hard stools and hemorrhoids or anal fissure
时间窗: 6 weeks
次要结局
- Gastrointestinal Symptoms Rating Scale(6 weeks)
- Bristol stool consistency scale(6 weeks)
- Number of episodes of rectal bleeding(6 weeks)
- Need of rescue medication(6 weeks)
研究者
研究点 (8)
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