Comparison of the effect of two treatment methods of polyethylene glycol with Motilium and polyethylene glycol with placebo in the treatment of chronic constipation in children with cerebral palsy
Comparison of the effect of two method of Polyethylene Glycol with Motilium and Polyethylene Glycol alone with Placebo in treatment of chronic Constipation in children with cerebral palsy.
Design
This study is a double-blinded clinical trial. The study population will be included all children with chronic cerebral palsy who referred to Mohammad Kermanshahi hospital of Kermanshah. 42 eligible patients will be selected conveniently and randomly will be assigned to two intervention and control groups.
Settings and conduct
This study will be conducted in Mohammad Kermanshahi hospital of Kermanshah is double-blinded one, in this way that participants and clinical care providers are unaware of the allocation of intervention and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with cerebral palsy suffer from chronic constipation;
Patients with chronic constipation who have not responded to usual treatments
Exclusion criteria: Children with cardiovascular problems based on E.C.G approval by a pediatric cardiologist
Intervention groups
The intervention group will receive polyethylene glycol with a dosage of 4.0 mg/kg with 0.2 mg/kg of Motilium three times a day for two weeks. The second intervention group will receive 4.0 mg/kg of polyethylene glycol with 0.2 mg/kg of placebo syrup (containing distilled water) once a day for two weeks.
Main outcome variables
Chronic constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N126
Registration date:2019-06-24, 1398/04/03
Registration timing:prospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two treatment methods of polyethylene glycol with Motilium and polyethylene glycol with placebo in the treatment of chronic constipation in children with cerebral palsy
Public title
Comparison of the effect of two treatment methods in the treatment of chronic constipation in children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cerebral palsy suffer from chronic constipation
Patients with chronic constipation who have not responded to usual treatments
Exclusion criteria:
Children with cardiovascular problems based on E.C.G approval by a pediatric cardiologist
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the clinical carers and participate will be blinded to the allocation of study groups to intervention and experimental groups. assigned to assign the study groups. In this way that clinical carers and participate are unaware of coding and allocation of intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
ir.kums.rec.1398.067
Health conditions studied
1
Description of health condition studied
chronic constipation
ICD-10 code
K92.9
ICD-10 code description
Disease of digestive system, unspecified
Primary outcomes
1
Description
Chronic constipation
Timepoint
Two weeks after the end of the study
Method of measurement
Asking the patients and abdominal examination
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive polyethylene glycol with a dosage of 4.0 mg/kg with 0.2 mg/kg of Motilium three times a day.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 4.0 mg/kg of polyethylene glycol with 0.2 mg/kg of placebo syrup (containing distilled water) once a day .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Masoud Norouzi
Street address
Crossroads of Helal Ahmar, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
drmasoudnorouzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Masoud Norouzi
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Crossroads of Helal Ahmar, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
drmasoudnorouzi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Yousefi
Position
Faculty member Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Digestion
Street address
Intersection of Helal Ahmar
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
Dr.g.yousefi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Masoud Norouzi
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Crossroads of Red Crescent, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
drmasoudnorouzi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 90-day period, the documents will be sent e-mail