Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ebastine, Placebo.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome - Diarrhoea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug ebastine
Tab. Ebastine 20mg once daily at night - Drug Placebo
Tab. Placebo once daily at night
Primary outcome measures
- 1. Improvement of diarrhea predominant IBS symptoms [Time frame: [At baseline before randomization and then at week 4, and 8 ]]
Secondary outcome measures (4)
- The effect of ebastine in diarrhea predominant IBS patients [Time frame: [At baseline before randomization and then at week 4, and 8]]
- The effect of placebo in diarrhea predominant IBS patients [Time frame: At baseline before randomization and then at week 4, and 8]
- Compare the effect of ebastine and placebo [Time frame: At baseline before randomization and then at week 4, and 8]
- Adverse events [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Dhaka Medical College — Dhaka
Identifiers
NCT: NCT07114055 · IRB-DMC/2025/52