Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome
Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dr. Md. Aminul Islam
- Numéro de téléphone: +8801626299434
- E-mail: aminulthesis0950@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Ramosetron 2.5 microgram
Group A - Ramosetron 2.5 microgram
|
Ramosetron 2.5 microgram will be given in Group A
|
|
Comparateur placebo: Placebo
Group B - Placebo
|
Placebo will be given in Group C
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Improvement of diarrhea predominant IBS symptoms
Délai: At baseline before randomization and then at week 4 and week 8
|
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS).
This score is a Likert scale with seven domains divided into two parts.
Part one is the severity score containing four domains, where domain one has two separate scoring scale.
Each scale scoring from 0 to 100, that makes it a total score of 500.
The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300).
The part two is a descriptive questionnaire about bowel habit
|
At baseline before randomization and then at week 4 and week 8
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The effect of ramosetron in diarrhea predominant IBS patients
Délai: At baseline before randomization and then at week 4 and week 8
|
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS).
This score is a Likert scale with seven domains divided into two parts.
Part one is the severity score containing four domains, where domain one has two separate scoring scale.
Each scale scoring from 0 to 100, that makes it a total score of 500.
The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300).
The part two is a descriptive questionnaire about bowel habit.
|
At baseline before randomization and then at week 4 and week 8
|
|
The effect of placebo in diarrhea predominant IBS patients
Délai: At baseline before randomization and then at week 4 and week 8
|
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS).
This score is a Likert scale with seven domains divided into two parts.
Part one is the severity score containing four domains, where domain one has two separate scoring scale.
Each scale scoring from 0 to 100, that makes it a total score of 500.
The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300).
The part two is a descriptive questionnaire about bowel habit.
|
At baseline before randomization and then at week 4 and week 8
|
|
Compare the effect of ramosetron and placebo
Délai: At baseline before randomization and then at week 4 and week 8
|
The improvement of IBS symptoms will be assessed by IBS symptom severity score (IBS-SSS).
This score is a Likert scale with seven domains divided into two parts.
Part one is the severity score containing four domains, where domain one has two separate scoring scale.
Each scale scoring from 0 to 100, that makes it a total score of 500.
The severity is denoted as Mild (Score 75 to 175), Moderate (Score 176 to 300), and severe (Score more than 300).
The part two is a descriptive questionnaire about bowel habit.
|
At baseline before randomization and then at week 4 and week 8
|
|
Adverse events
Délai: through study completion, approximately 1 year
|
Patient reported adverse events will be documented
|
through study completion, approximately 1 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB-DMC/2025/259
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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