CTRI/2017/11/010539已完成3 期
A Multi-Center, Double Blind, Randomized, Parallel-Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of Bacillus Coagulans Unique IS2 capsules in the Treatment of Functional Constipation in Adults.
nique Biotech Ltd0 个研究点目标入组 100 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
- 100
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.Male or female subject aged between 18 and 65 years old (both inclusive).
- •2.Has diagnosis of functional constipation according to Rome Criteria III.
- •3.Willing to give IEC approved informed consent.
- •4. Willing to abide by the study requirements.
排除标准
- •1.Subjects who have undergone major abdominal surgery.
- •2.Subjects with a documented history of slow colonic transit.
- •3.Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
- •4.Subjects with clinical features suggestive of alarming symptoms (rectal bleeding, weight loss, etc.)
- •5.Family history of peptic ulcer, colorectal cancer, or IBD
- •6.Abnormal laboratory data or thyroid function.
- •7.Participated in any clinical trial in the past 90 days.
- •8.Have received any probiotic formulation in the past 30 days.
- •9.Known or expected hypersensitivity to any of the active substances or excipients.
- •10.Subject is pregnant or lactating.
- •11.Subject allergic or atopic to any of the ingredients of the study medication
研究者
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