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
Sponsors and collaborators
Md. Hazrat Ali
Lead sponsor
Dhaka Medical College
Sponsor institution