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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Dr. Md. Aminul Islam
- Telefonní číslo: +8801626299434
- E-mail: aminulthesis0950@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Ramosetron 2.5 microgram
Group A - Ramosetron 2.5 microgram
|
Ramosetron 2.5 microgram will be given in Group A
|
|
Komparátor placeba: Placebo
Group B - Placebo
|
Placebo will be given in Group C
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improvement of diarrhea predominant IBS symptoms
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The effect of ramosetron in diarrhea predominant IBS patients
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: through study completion, approximately 1 year
|
Patient reported adverse events will be documented
|
through study completion, approximately 1 year
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB-DMC/2025/259
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