Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Improvement of diarrhea predominant IBS symptoms
研究概览
简要总结
The goal of this clinical trial is to assess and compare the effect of ebastine and placebo in improving symptoms in patients with diarrhea predominant IBS. It will also assess about the safety of drugs ebastine and placebo by recording the patient reported adverse events. The main questions it aim to answer are:
Does drug ebastine and placebo has any effect on patients with IBS-D? What medical problems do participants have when taking drug ebastine and placebo? Researcher will compare effect of drug ebastine and placebo .
Participant will:
Take drug ebastine 20 mg at night and placebo once daily at night every day for 8 weeks along with lifestyle modifications. After that all two groups will visit the hospital 4 weekly, and their symptoms will be assessed by IBS symptom severity score (IBS-SSS) at baseline, week 4 and week 8. Additionally, patient reported adverse events will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ebastine
Tab. Ebastine 20mg once daily at night
干预措施: ebastine (Drug)
Placebo
Tab. Placebo once daily at night
干预措施: Placebo (Drug)
结局指标
主要结局
1. Improvement of diarrhea predominant IBS symptoms
时间窗: [At baseline before randomization and then at week 4, and 8 ]
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS). This score is a Likert scale with seven domains divided into two parts. Part one is the severity score containing four domains, where domain one has two separate scoring scale. Each scale scoring from 0 to 100, that makes it a total score of 500. The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300). The part two is a descriptive questionnaire about bowel habit.
次要结局
- The effect of ebastine in diarrhea predominant IBS patients([At baseline before randomization and then at week 4, and 8])
- The effect of placebo in diarrhea predominant IBS patients(At baseline before randomization and then at week 4, and 8)
- Adverse events(through study completion, an average of 1 year)
- Compare the effect of ebastine and placebo(At baseline before randomization and then at week 4, and 8)
研究者
Md. Hazrat Ali
Principal Investigator
Dhaka Medical College