Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome

NCT07114055 | Recruiting Phase 2 DMC

• 1 other identifier: IRB-DMC/2025/52
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome - Diarrhoea

Keywords

Ebastine

Outcome Measures

Primary Outcomes (1)

• 1. Improvement of diarrhea predominant IBS symptoms

  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.

  [At baseline before randomization and then at week 4, and 8 ]

Secondary Outcomes (4)

• 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

• Compare the effect of ebastine and placebo

  At baseline before randomization and then at week 4, and 8

• Adverse events

  through study completion, an average of 1 year

Study Arms (2)

Ebastine

ACTIVE COMPARATOR

Tab. Ebastine 20mg once daily at night

Drug: ebastine

Placebo

PLACEBO COMPARATOR

Tab. Placebo once daily at night

Drug: Placebo

Interventions

ebastine DRUG

Tab. Ebastine 20mg once daily at night

Ebastine

Placebo DRUG

Tab. Placebo once daily at night

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Patients who meet the Rome IV criteria for IBS-D.

You may not qualify if:

• Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer
• History of major gastrointestinal surgery
• Medical disease that affect the digestive system, such as uncontrolled diabetes, hyperthyroidism, hypothyroidism
• Pregnant and lactating women
• Vehicle drivers, mechanical operators and aerial operators
• Drug abuse or alcohol abuse

Sponsors & Collaborators

• Md. Hazrat Ali: lead

Study Sites (1)

Dhaka Medical College

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Interventions

ebastine

Central Study Contacts

Md. Hazrat Ali, MBBS

CONTACT

+8801710725424; mhalirmc45@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

BA (1)