Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMd. Hazrat Ali

About this trial

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

Qualifiers

Age 18 and above

Patients who meet the Rome IV criteria for IBS-D.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ebastine
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Md. Hazrat Ali

Lead sponsor

Dhaka Medical College

Sponsor institution