Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Md. Hazrat Ali

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Irritable Bowel Syndrome - Diarrhoea

Treatments: Drug: Placebo; Drug: ebastine

Study type: Interventional

Funder types: Other

Identifiers

NCT07114055

IRB-DMC/2025/52

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Ebastine

Active Comparator group

Description:

Tab. Ebastine 20mg once daily at night

Treatment:

Drug: ebastine

Placebo

Placebo Comparator group

Description:

Tab. Placebo once daily at night

Treatment:

Drug: Placebo