Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ramosetron 2.5 microgram, Placebo.
- Who it may be relevant to
- Registry conditions: IBS-D (Diarrhea-predominant). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
Overview
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.
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
Primary outcome measures
- Improvement of diarrhea predominant IBS symptoms [Time frame: At baseline before randomization and then at week 4 and week 8]
Secondary outcome measures (4)
- The effect of ramosetron in diarrhea predominant IBS patients [Time frame: At baseline before randomization and then at week 4 and week 8]
- The effect of placebo in diarrhea predominant IBS patients [Time frame: At baseline before randomization and then at week 4 and week 8]
- Compare the effect of ramosetron and placebo [Time frame: At baseline before randomization and then at week 4 and week 8]
- Adverse events [Time frame: through study completion, approximately 1 year]
Eligibility criteria
Inclusion criteria
- Adults aged 18-65 years.
- Patients fulfilling Rome IV diagnostic criteria for IBS-D.
- Willing to provide informed written consent.
- Patients able to attend regular follow-up visits during the study period.
Exclusion criteria
- Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer or inflammatory bowel disease
- History of major gastrointestinal surgery (excluding appendicitis )
- Recent antibiotic use within 4 weeks
- Patient with uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Pregnant or lactating women
- Drug abuse or alcohol abuse
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07574320 · IRB-DMC/2025/259