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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr. Md. Aminul Islam
- Número de teléfono: +8801626299434
- Correo electrónico: aminulthesis0950@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ramosetron 2.5 microgram
Group A - Ramosetron 2.5 microgram
|
Ramosetron 2.5 microgram will be given in Group A
|
|
Comparador de placebos: Placebo
Group B - Placebo
|
Placebo will be given in Group C
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement of diarrhea predominant IBS symptoms
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The effect of ramosetron in diarrhea predominant IBS patients
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: through study completion, approximately 1 year
|
Patient reported adverse events will be documented
|
through study completion, approximately 1 year
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB-DMC/2025/259
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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