Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome - Diarrhoea
• Interventions: Drug: ebastine; Drug: Placebo

• Registration Number: NCT07114055
• Lead Sponsor: Md. Hazrat Ali

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-08
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-03
• Study First Posted: 2025-08-11
• Study Start: 2025-08-15
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ebastine	ebastine	Tab. Ebastine 20mg once daily at night
Placebo	Placebo	Tab. Placebo once daily at night

Primary Outcome Measures

Name	Time	Method
1. Improvement of diarrhea predominant IBS symptoms	[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.

Secondary Outcome Measures

Name	Time	Method
The effect of ebastine in diarrhea predominant IBS patients	[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.
The effect of placebo in diarrhea predominant IBS patients	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.
Compare the effect of ebastine and placebo	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.
Adverse events	through study completion, an average of 1 year	Patient reported adverse events will be documented

Trial Locations

Locations (2)

Dhaka Medical College; 🇧🇩 Dhaka, Bangladesh

Dhaka Medical College; 🇧🇩 Dhaka, Bangladesh