Use of duloxetine compared with imipramine in the treatment of diarrhea in patients with irritable bowel syndromedue to more complications of TCA
Design
Clinical trial with controled group with parallel and randomizied group
Settings and conduct
48 Patients with irritable bowel syndrome,including 24 females and 24 males,were examined by gastroenterologist and based on Rome III Criteria for definitive diagnosis of irritable bowel syndrome after rejecting other diagnosis and have diarrhea after obtaining the consent they enter the study.Randomization will take place in 4 groups based on permutation block randomization and base on 2 blocks.patients in control group treated with dicyclomine and imipramine at the dose of 10 mg will increase to 25 mg 2 weeks if not treated. and in the case group treated with dicyclomine and duloxetine at the dose of 20 mg will increase to 60 mgif needed.patients results are compared before and 3 months after treatment{mostly diarrhea}
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with irritable bowel syndrome and diarrhea perdominance base on Rome III criteria
Exclusion criteria:pregnancy/lactation/history ofany bowel surgeryexcept appandectomy/Dissatisfaction to be include in the study/Drugs use interferes with duloxetine/diabet/Infectious diarrhea/Inflammatory bowel disease
Intervention groups
Patients were randomly divided into two groups of 24,which were given to a drug group with duloxetine 20 mg and if as need increase to 60mg in 2 weeks and another group with Imipramin 10 mg and if as need increase to 25 mg in 2 weeks for 3 months.
Main outcome variables
The number of emergency defication per day/The number of days with bloating per week/The nember of days with pain per week/Frequency of diarrhea per day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044084N1
Registration date:2020-02-03, 1398/11/14
Registration timing:retrospective
Last update:2020-02-03, 1398/11/14
Update count:0
Registration date
2020-02-03, 1398/11/14
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
2019-08-27, 1398/06/05
Expected recruitment end date
2019-11-26, 1398/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of duloxetine and imipramine on diarrhea improvement in outpatients with irritable bowel syndrome with diarrhea predominance
Public title
Comparison of the effect of duloxetine and imipramine on diarrhea treatment in patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with irritable bowel syndrome and diarrhea predominance between the ages of 18-40 years based on Rome III criteria
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study 48 patients with irritable bowel syndrome,including 24 women and 24 men,will be included in the study.Randomization will be done in 4 groups on the weber permutation block randomization basis of 4 blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی زنجان
Street address
No1.Jomhori Blvd,Azadi squqre,zanjan city
City
zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-07-02, 1398/04/11
Ethics committee reference number
IR.ZUMS.REC.1398.074
Health conditions studied
1
Description of health condition studied
Irritable Bowel syndrom with diarrhea perdominnace
ICD-10 code
Irritable
ICD-10 code description
K58
Primary outcomes
1
Description
Diarrhea,abdominal pain,age,sex
Timepoint
Beginning of the study and 3 months later
Method of measurement
IBS severity score questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dluxetine 20mg and if needed increase to 60 mg for up to 3 months and Control group:Imipramine 10mg and if needed increase to 25 mg for up to 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Vali-e-Asr Hospital
Full name of responsible person
Sattar jafari
Street address
Vali-e-Asr squqre,Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
jafari1354@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice chancellor for research,Zanjan Univercity of medical sciences
Street address
No1,Jomhori Blvd,Azadi square,Zanjan city
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3377 0801
Email
jafari1354@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
Medical Education
Street address
Valiasr sq,valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
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
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr sq,Valiasr hospital
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 jafary
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr sq,Valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
4551777978
Phone
+98 24 3377 0801
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