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NCT Number: NCT07114055

Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome - Diarrhoea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

ebastine

Drug

Tab. Ebastine 20mg once daily at night

Placebo

Drug

Tab. Placebo once daily at night

Primary outcomes

  1. 1. Improvement of diarrhea predominant IBS symptoms

    Time frame: [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 outcomes

  1. The effect of ebastine in diarrhea predominant IBS patients

    Time frame: [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.

  2. The effect of placebo in diarrhea predominant IBS patients

    Time frame: 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.

  3. Compare the effect of ebastine and placebo

    Time frame: 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.

  4. Adverse events

    Time frame: through study completion, an average of 1 year

    Patient reported adverse events will be documented

Study contacts

Contact information is provided by the study sponsor or research team.

Md. Hazrat Ali, MBBS

CONTACT

[email protected]

+8801710725424

Sponsors and collaborators

Lead sponsor

Md. Hazrat Ali

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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