CTRI/2015/01/005349已完成3 期
A Clinical study to evaluate efficacy and safety of Ayulax Capsule in the Management of Functional Constipation - NI
Welex Laboratories Pvt Ltd0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •a. Straining during at least 25 percent of defecations
- •b. Lumpy or hard stools at least 25 percent of defecations
- •c. Sensation of incomplete evacuation at least 25 percent of defecations
- •d. Sensation of anorectal blockage at least 25 percent of defecations
- •e. Manual maneuvers to facilitate at least 25 percent of defecations
- •f. Fewer than three defecations per week
- •2. Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale
排除标准
- •1. Subjects with diagnosed colonic inertia.
- •2. Subjects who have recently undergone abdominal surgery
- •3. Subjects with history of anorectal surgery.
- •4. Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e. IBS, Belching disorders etc.)
- •5. Subjects with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis.
- •6. Subjects with renal or liver dysfunction
- •7. Pregnant or lactating females
- •8. Subjects with disturbed thyroid functions
研究者
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