The plan of this study is to compare efficacy of brown sugar syrup and poly ethylene glycol (PEG) for treatment of constipation in children.122 children above 2 years old suffering from functional constipation will be studied. The study is pilot , randomized and open label (not blinded). Patients will be recruited in two groups (n=61) and one of the above medication will be administered for four weeks.
Defecation، constipation، number of defecations and drug adoption will be assessed.
Inclusion criteria is children above 2 years old with functional constipation and
Exclusion criteria are hypothyroidism; hirschprung Disease and congenital anomalies.
Location of study is Amir Almomenin Hospital, Semnan, Iran.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061722794N1
Registration date:2015-07-24, 1394/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Bahador Bagheri
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 326 8059
Email address
bagherib@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Semnan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of brown sugar on functional constipation compared to poly ethylene glycol in children
Public title
The effect of brown sugar on functional constipation compared to poly ethylene glycol in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children above 2 years old with functional constipation
Exclusion criteria: Hypothyroidism; Hirschprung Disease; Congenital anomalies
Age
From 2 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
IR.SEMUMS.REC.1394.17
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Defecation
Timepoint
2 week and 4 week
Method of measurement
Parents
2
Description
Constipation
Timepoint
2 week and 4 week
Method of measurement
Parents
3
Description
Number of defecations
Timepoint
2 week and 4 week
Method of measurement
Parents
Secondary outcomes
1
Description
Drug adoption
Timepoint
Every day
Method of measurement
Parents
Intervention groups
1
Description
Control group: Patients will receive 2 mg/kg poly ethylene glycol for two weeks, if successful it will be continued for the next two weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Patients will receive 2 mg/kg poly ethylene glycol for two weeks, if successful it will be continued for the next two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Almomnin Hospital
Full name of responsible person
Street address
Amir Al momenin hospital, Mostafa Khomeini Blvd
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidipour
Street address
Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Assitant professor of pharmacology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Phone
+98 912 326 8059
Fax
Email
bagherib@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Assitant professor of pharmacology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvds
City
Semnan
Postal code
Phone
+98 912 368 059
Fax
Email
bagherib@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)