CTRI/2019/02/017407已完成3 期
A Double-Blind, Randomized, parallel (adaptive) clinical study to evaluate the efficacy and safety of 3 different types of formulations on bowel function.
ITC Life Science and Technology center1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2019年5月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- •Assessment of Bowel function , stool frequency and consistency, PH, fecal questioner
研究概览
简要总结
Once recruitment will be completed then study will be published with approval of sponsor.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Elderly with digestive complaints (Bowel Function)}.
- •Male or Female Age 55-65 years. (E.g. Documented History of Chronic Constipation, IBS, Diarrhea, Stomach pain etc. (For Group –A )
- •Constipated Subjects (complaints of hard and lumpy stools) – Male or Non-pregnant Female Age 18- 50 years ( For Group – B )
- •Healthy subjects (as defined by medical history & physical examination)-male or non-pregnant female – Age 18- 50 years (For Group C )
- •Rome-III diagnostic criteria prescribed for IBS. (For Group – B) (Annexure I) 5.Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with changes in frequency of stool. (Group-B) 6.Relief of pain or discomfort with defecation. (Group – B)
- •Capability to provide written informed consent (For all Groups).
排除标准
- •1.The subject has a serious, unstable medical condition,such as lung disease,uncontrolled blood pressure,uncontrolled thyroid function,a physical or medical disability or an advanced medical condition.
- •2.The subject had previous significant gastric or intestinal surgery except appendectomy and gall bladder surgery.
- •3.IBS sub type other than IBS associated with Constipation.
- •4.Diarrhea more than 3 bowel movements per day.
- •5.Antibiotic use within 4 weeks of randomization.
- •6.Pregnant or lactating women.
- •7.Subjects on the ongoing therapies with the drugs known to effect gut motility e.g. Laxatives, prokinetics, etc.
- •8.Subject with eating disorder.
- •9.History of alcohol, drug, or medication abuse.
- •10.Participation in another study with any investigational product (IP) within 3 months of randomization.
- •11.Subject with any condition that might interfere with the conduct of the study as per Investigator’s opinion.
- •12.Known allergies to any substance in the study product, including lactose intolerance and galactosemia.
结局指标
主要结局
•Assessment of Bowel function , stool frequency and consistency, PH, fecal questioner
时间窗: Group A Day 1, Day 14, Day 60, Day 75 | Group B&C Day 1, Day 14, Day 28, Day 43
次要结局
- • Bowel function-stool frequency and consistency(• Microflora composition (Lactobacilli, Bifidobacteria))
研究者
研究点 (1)
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