Determination and comparison of the effect of simultaneous administration of polyethylene glycol and fig syrup on the treatment of chronic constipation in children
Design
Double-blind, randomized clinical trials
Settings and conduct
All types of drugs used with the same label, which are labeled only by the consultant's pharmacist, are available to the researcher. The distribution method is that 3 cards with different colors are placed in front of the patient and the patient chooses one. Each color is one of three models of syrup. The patient information form is also reserved for the physician's secretary, and the physician and researcher are not aware of it.
Participants/Inclusion and exclusion criteria
Entry Criteria: Chronic functional constipation, ages 2 to 15 years, lack of large and small intestinal diseases, insensitivity to figs or polyethylene glycols, lack of bowel obstruction, lack of kidney or heart failure. Exit criteria: the development of diarrhea following drug use and unwanted allergic reactions following drug intake, lack of cooperation and desire of the individual during the study to continue the company
Intervention groups
The first group consume 5 ml of fig juice every 3 times each day. The second group daily consumes 1 g / kg of body weight water soluble polyethylene glycol powder, and the third group daily uses 3 times and each time 5 ml of fig juice and 1 g per kilogram body weight of water soluble polyethylene glycol powder They do.
Main outcome variables
Evaluation and comparison of chronic functional constipation based on interviews and checklist in intervention groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N2
Registration date:2018-08-15, 1397/05/24
Registration timing:registered_while_recruiting
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-08-24, 1397/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of coadministration of polyethylene glycol and fig syrup for the treatment of chronic functional constipation in children
Public title
Fig syrup effect on the treatment of chronic constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic functional constipation
Age 2 to 15 years
Lack of colon and small diseases
Insensitivity to fig or polyethylene glycol
Lack of bowel obstruction
The absence of kidney or heart failure
Exclusion criteria:
Creating diarrhea after taking medication and creating unwanted allergic reactions following drug intake
The lack of cooperation and the person's desire to continue the company during the study
Age
From 2 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
All types of drugs used with the same label, which are labeled only by the consultant's pharmacist, are available to the researcher. The distribution method is that 3 cards with different colors are placed in front of the patient and the patient chooses one. Each color is one of three models of syrup. The patient information form is also reserved for the physician's secretary, and the physician and researcher are not aware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SKUMS.REC.1396.243
Health conditions studied
1
Description of health condition studied
chronic functional constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified
Primary outcomes
1
Description
The number of fecal excretions per week, the number of unwanted fecal excretions per week, the number of fecal excretions in the patient with pain, the number of times the patient experiences abdominal pain, the quality and consistency of fecal excretion
Timepoint
At the beginning of the study, 2, 4, 6 weeks after the start of the intervention
Method of measurement
Checklist provided by the parents of patients
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group:3 times a day, and take 5 ml of fig juice every time.
Category
Treatment - Drugs
2
Description
Second intervention group:1 g per kilogram body weight per day consumes water-soluble polyethylene glycol powder.
Category
Treatment - Drugs
3
Description
Third intervention group:3 times a day, and each time 5 ml of fig juice syrup and 1 g per kilogram body weight per day, they consume water-soluble polyethylene glycol powder.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Narges Maleki
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
nmaleeky@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
nmaleeky@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
nmaleeky@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
nmaleeky@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
nmaleeky@gmail.com
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
Confidential information is kept.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main consequence of sharing is possible.
When the data will become available and for how long
Start the access period 4 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete fundamental studies
From where data/document is obtainable
Hajar Hospital in Shahrekord
nmaleeky@gmail.com
What processes are involved for a request to access data/document
Investigating the request of the researcher and providing sufficient documentation of his research and the reason for using the data can be provided.