The effect of ondansetron in treatment of patients with diarrhea dominant irritable bowel syndrome (IBS)
Design
A randomized controlled clinical trial with double blinded and randomized parallel groups
Settings and conduct
This study will be conducted in Valiasr hospital. Patients were randomly divided to two groups of intervention and control. For 2 months, the intervention group will receive imipramine and ondansetron; while control group will receive imipramine and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with irritable bowel syndrome and diarrhea predominance based on Rome III criteria, age between 18-50 years.
Exclusion criteria: Pregnancy, Lactation, Dissatisfaction to be include in the study, Any sign and symptom of inflammatory bowel disease, Psychiatric drug use, History of drugs Interaction with ondansetron, Bowel surgery except appendectomy and cholecystectomy
Intervention groups
Intervention group: 50 patients treated by Imipramine (made by Abidi Pharma Compony) daily 25 mg and ondansetron (made by Abidi Pharma Compony) 4mg 3 times per day for up to 2 months.
Control group: 50 patients treated by Imipramine (made by Abidi Pharma Compony) daily 25 mg and placebo (containing Avicel and made by the School of Pharmacy) 4mg 3 times per day for up to 2 months.
Main outcome variables
Defecation urgency؛ Bloating; Pain; Diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044084N2
Registration date:2020-04-20, 1399/02/01
Registration timing:retrospective
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
sattar jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 0801
Email address
jafari1354@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-27, 1398/04/06
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ondansetron in the treatment of patients with diarrhea dominant irritable bowel syndrome (IBS)
Public title
ٍٍEffect of ondansetron in treatment of irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with irritable bowel syndrome with diarrhea predominance based on Rome III criteria
Age:Between 18-50 years
Exclusion criteria:
Pregnancy
Lactation
Dissatisfaction to be included in the study
Any sign and symptom of inflammatory bowel disease
Psychiatric drug use
Drugs Interaction with ondansetron including: p450 enzyme system inducers (carbamazepine, phenobarbital, phenytoin, dexamethasone, rifampicin) p450 enzyme system inhibitors (clarithromycin erythromycin ketoconazole) 3
History of any bowel surgery except appendectomy and cholecystectomy
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 100 patients with irritable bowel syndrome will be randomly studied in two groups, each including 50. Randomization in the mentioned groups will be conducted according to permuted block randomization based on quaternary blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind and placebo-controlled study. Placebo will be provided similar to androsterone in terms of taste, flavor and color, by the School of Pharmacy. The content of Placebo is Avicel. Medicines will be delivered to patients by a third person (a health care provider) who is not directly involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
No 1. Jomhori boulvard, Azadi square, Zanjan city.
Intervention group: 50 patients treated by Imipramine (made by Abidi Pharma Compony) daily 25 mg and ondansetron (made by Abidi Pharma Compony) 4mg 3 times per day for up to 2 months.
Category
Treatment - Drugs
2
Description
Control group: 50 patients treated by Imipramine (made by Abidi Pharma Compony) daily 25 mg and placebo (containing Avicel and made by the School of Pharmacy) 4mg 3 times per day for up to 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Sattar Jafari
Street address
Hazrat Valiasr Training Center, Valiasr Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
valiasr@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Maedical Science Central Office, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۶۱۳۱۹۱
Phone
+98 24 3342 0651
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sattar Jafari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr hospital, Valiasr square.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Fax
Email
jafari1354@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sattar Jafari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr hospital, Valiasr square.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
jafari1354@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sattar Jafari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr hospital, Valiasr square.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
0098 24337770801
Email
jafari1354@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD