Prospective, Interventional, Comparative, Single Center, Cross-Over Study for Evaluation of Efficacy of Kiwibiotic Vs Psyllium Husk for Functional Constipation, Abdominal Pain and Bloating.
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- •The primary endpoint compared the change in the symptoms of functional constipation, Abdominal pain & bloating.
研究概览
简要总结
Functional constipation (FC) is a clinically common functionalgastrointestinal disorder that affects both children and adults all over theworld. FC, also known as chronic idiopathic constipation, is a type ofchronic constipation caused by dysfunction or disturbance in the physiologicalfunctions of defecation for a variety of reasons other than irritable bowelsyndrome (IBS), and without organic lesions or structural abnormalities thatcause defecation difficulty.Existing research has shown that sedentarylifestyles, dietary habits and types such as low vegetable and fruit intake(low dietary fibre), insufficient water intake, and low levels of education allcontribute to an increased prevalence of FC. Laxatives are commonly usedas first-line pharmacological therapy as they are cheap and readily availableover the counter.
Kiwifruit has varioususes in Gastrointestinal disorders. The components found in kiwifruit have beenshown to increase fecal bulking and softness and enable better lubrication,assisting the propulsion of content along the colon. It is thought that theunique combination of soluble and insoluble fibres, polyphenols and actinidin,present in kiwifruit, confers gastrointestinal benefits, improvements inlaxation and reduction of abdominal discomfort, both in individuals with eitherconstipation-predominant irritable bowel syndrome (IBS-C) and in normal healthypeople suffering from constipation without reported side effects. The putativemechanism of kiwifruit on the maintenance of normal GI function has recentlybeen reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients aged ≥18 years of age.
- •2.Patient with a diagnosis of Functional constipation, Abdominal Pain and bloating.
- •3.Patient/Parent/legal guardian willing to give a written informed consent/parental consent/assent form.
- •4.Able to/Willing to strictly adhere to the investigator’s prescription.
排除标准
- •Exclusion criteria: 1.Individuals were excluded if they had taken any medications which might interfere with the action of the study medications prior to the start of the study or during the study.
- •2.Patient having any existing conditions that might compromise their safety or participation in the study.
结局指标
主要结局
•The primary endpoint compared the change in the symptoms of functional constipation, Abdominal pain & bloating.
时间窗: •upto 5th visit i.e.Day 49.
次要结局
- •Secondary endpoints evaluate the Gastrointestinal Quality of Life Index of Patients suffering from Functional constipation, abdominal pain & bloating [Time Frame: up to 5th Visit](•Overall treatment evaluation (OTE) scores by physician. [Time Frame: up to 5th Visit])
