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.
Age 18 and above
Patients who meet the Rome IV criteria for IBS-D.
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
Parallel
ebastine
DrugTab. Ebastine 20mg once daily at night
Placebo
DrugTab. Placebo once daily at night
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.
The effect of ebastine in diarrhea predominant IBS patients
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
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
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
Patient reported adverse events will be documented
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Md. Hazrat Ali
Lead sponsor
Dhaka Medical College
Sponsor institution
