NCT00522093已完成不适用
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
研究概览
简要总结
TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.
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
- 20 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
- •had symptoms of abdominal bloating or discomfort
排除标准
- •mechanical bowel obstruction
- •clinically systemic disease-induced constipation
- •pregnancy
结局指标
主要结局
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Akira Horiuchi
Digestive Disease Center
Showa Inan General Hospital
研究点 (2)
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