Comparison the effects of syrup of Zyzyphus jujube and Pidrolax Glycol in treatment of 2-10 years Children with Functional Constipation referred to 17-Shahrivar Hospital; A double-blind randomized clinical trial
Comparison of Ziziphus jujuba Mill. syrup with pidrolax (Polyethylene Glycol)
Design
Double Blinded clinical trial
Settings and conduct
This study will be done because of no certain treatment for functional constipation in children. It will be held on pediatric clinic in 17-shahrivar hospital in Rasht as a double blinded clinical trial study.
blinding will be done for both physician and patient toward type of prescribing drugs.
Participants/Inclusion and exclusion criteria
children between 2-10 years old will be included in the study
participants with hirschsprung disease, spina bifida occulta, cystic fibrosis, neurological abnormality, congenital anal disorders, Ogilvie syndrome, celiac disease, hypothyroidism, Diabetes insipidus, history of colorectal surgery, existence of fissure and no consent of parent for participation, will not included in the study
Intervention groups
Ziziphus jujuba mill syrup group,
Pidrolax group
Main outcome variables
Visual Analogue Scale and pediatric functional constipation scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131006014915N3
Registration date:2018-09-26, 1397/07/04
Registration timing:prospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Amin Saeidinia
Name of organization / entity
Medicinal plants research center of student Basij, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1669 0099
Email address
a.saeidynia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of syrup of Zyzyphus jujube and Pidrolax Glycol in treatment of 2-10 years Children with Functional Constipation referred to 17-Shahrivar Hospital; A double-blind randomized clinical trial
Public title
evaluation of Zyzyphus jujuba syrup in treatment of functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
functional constipation
age between 2-10 years
Exclusion criteria:
Hirschsprung disease
spina bifida occulta
cystic fibrosis
neurologic disorder
anal congenital disorders
ogilvie disease
celiac disease
Hypothyroidism
diabetes insipidus
history of colorectal surgery
fissure
no consent of patients
Age
From 2 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is two-sided. it means that both physician and patient will be blind toward drug type. for this purpose, trained nurse is aware of randomization but physician and patient are blinded.
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 گیلان
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.GUMS.REC.1397.157
Health conditions studied
1
Description of health condition studied
functional constipation
ICD-10 code
K59.9. Fun
ICD-10 code description
K59.0. Constipation
Primary outcomes
1
Description
Visual Analogue Scale
Timepoint
in the starting day of study (before intervention), 1 and 2 months after starting drugs
Method of measurement
by using ruler of pain determination between 0 to 10
Secondary outcomes
1
Description
pediatric functional constipation scale
Timepoint
in the starting day of study (before intervention), 1 and 2 months after starting drugs
Method of measurement
weak, moderate, good
Intervention groups
1
Description
First Intervention group: Oral consumption of ziziphus jujuba syrup prepared by pharmacist, 1-2 cc/day for two months
Category
Treatment - Drugs
2
Description
Second Intervention group: Oral consumption of syrup prepared by Pidrolax powder, 1 cc/kg one time per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17-shahrivar hospital
Full name of responsible person
Shohreh Maleknejad
Street address
pediatric department, 17-shahrivar hospital, Namjoo street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3336 9019
Email
maleknejadshohreh@yahoo.com
Web page address
http://www.gums.ac.ir/17shahrivar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shohreh Maleknejad
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3336 9044
Email
maleknejadshohreh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
fateme keihanian
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
First Floor, Medical Faculty, Guilan University, 5th Kilometer of Tehran road, Rasht
City
Rasht
Province
Guilan
Postal code
3363
Phone
+98 13 3369 0884
Email
fatemekeihanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amin Saeidinia
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Medical faculty, Guilan University, 10th kilometer Tehran road, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
3363
Phone
+98 13 1669 0099
Fax
Email
a.saeidynia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amin Saeidinia
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Medical faculty, Guilan University, 10th kilometer Tehran road, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
3363
Phone
+98 13 1669 0099
Fax
Email
a.saeidynia@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Main outcomes of the study will be shared as an article after blinding participants' information
When the data will become available and for how long
Initiation of access to data will be at 6 months after publication of the work
To whom data/document is available
Scientific and academic researchers
Under which criteria data/document could be used
access to data will be only for result evaluation for target journal in publication process and only published findings in the article will be accessed to other researchers
From where data/document is obtainable
correspondence author of the study
What processes are involved for a request to access data/document
Sending request to corresponding author's email and if confirmed, sending the requested information will be done