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Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome

NCT07574320 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-07

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.

Patients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospital (DMCH) meeting the inclusion criteria of Diarrhea predominant irritable bowel syndrome (IBS-D) will be initially enrolled for the study. Their history, clinical examination \& initial investigations will be done. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study.

Each patient will go through a run-in period of 7 days. Number of subjects will be recruited according to sample size. Randomization into two groups will be performed by online randomizer websites.

One group will receive tablet ramosetron 2.5 mcg one time daily at morning before breakfast while the other group will receive identical looking placebo one tablet once daily at same time. Both groups will be adviced for low FODMAP diet along with lifestyle modification. The tablets will be administered for total 4 weeks. Before starting treatment, each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS Symptom Severity Score (IBS-SSS) will be recorded. Patients will be followed-up after 4 weeks and 8 weeks by IBS-SSS questionnaire. Any adverse effect will be reported quickly and documented at the same time.

IBS-SSS is a 5 item tools. It is primarily measures the IBS symptoms which includes abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100.

Conditions

  • IBS-D (Diarrhea-predominant)

Interventions

DRUG

Ramosetron 2.5 microgram

Ramosetron 2.5 microgram will be given in Group A

DRUG

Placebo

Placebo will be given in Group C

Sponsors & Collaborators

  • Md. Aminul Islam

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-01-01
Completion
2027-02-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574320 on ClinicalTrials.gov