NCT07114055 Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome
| NCT ID | NCT07114055 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Md. Hazrat Ali |
| Condition | Irritable Bowel Syndrome - Diarrhoea |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-08-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07114055 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome - Diarrhoea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07114055 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07114055 currently recruiting?
Yes, NCT07114055 is actively recruiting participants. Contact the research team at mhalirmc45@gmail.com for enrollment information.
Where is the NCT07114055 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT07114055 clinical trial?
NCT07114055 is sponsored by Md. Hazrat Ali. The trial plans to enroll 60 participants.