Comparative evaluation Pidrolax powder and simultaneous use laxa plus syrup and Pidrolax powder in the pediatric functional constipation in patients 4 to 10 years old
Comparative evaluation between the Pidrolax with laxa plus and Pidrolax in the pediatric functional constipation in chidren 4 to 10 years old
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, sample size equal to 108 patients. Duration of treatment 2 months
Settings and conduct
Pediatric Clinic of Golpayegani Hospital in Qom
Participants/Inclusion and exclusion criteria
Functional constipation confirmed by ROME 3 criteria(At least 2 out of 6 criteria Rome III)
Exclusion criteria: no bowel surgery and no hypothyroidism
Intervention groups
The intervention group was treated with Pidrolax plus Laxa plus and the control group was treated with Pidrolax plus placebo.
Main outcome variables
Constipation treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201029049185N1
Registration date:2020-11-26, 1399/09/06
Registration timing:retrospective
Last update:2020-11-26, 1399/09/06
Update count:0
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Mohammad Mohebali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 1380
Email address
m.mohebali47@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2019-11-21, 1398/08/30
Actual recruitment end date
2020-06-21, 1399/04/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparative evaluation Pidrolax powder and simultaneous use laxa plus syrup and Pidrolax powder in the pediatric functional constipation in patients 4 to 10 years old
Public title
Comparison between the Pidrolax and simultaneous use laxa plus and Pidrolax in the pediatric constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Functional constipation confirmed by ROME III criteria
Exclusion criteria:
Hypothyroidism and history of bowel surgery
Age
From 4 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and their parents did not know the classification
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sari University of Medical Sciences
Street address
Imam Square (RA) Joibar three ways, the beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.IAU.SARI.REC.1398.118
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.09
ICD-10 code description
Other constipation
Primary outcomes
1
Description
Constipation treatment
Timepoint
End of the second and fourth months after treatment
Method of measurement
Self-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group received Pidrolax plus Laxa plus medication regimen. Pidrolax 10 grams daily and 2.5 cc of Laxa plus
Category
Treatment - Drugs
2
Description
Control group: Patients in this group received Pidrolax plus placebo medication regimen. Pidrolax in the amount of 20 grams daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Clinic of Ayatollah Golpayegani Hospital, Qom
Full name of responsible person
Mohammad MohebAli
Street address
Motahhari Square, Rahbar Street
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
+98 25 3616 1111
Email
h.golpayegani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Qolam Reaza Najafi
Street address
Pardisan, University Blvd.
City
Qom
Province
Ghoum
Postal code
3749113191
Phone
+98 25 3280 8080
Email
q_najafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohmad Javad Qasem zade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3719463744
Phone
+98 25 3778 0001
Email
qasemzade.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad MohebAli
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
3714963744
Email
M.mohebali47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad MohebAli
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
+98 25 3778 0001
Email
M.mohebali47@gmail.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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers working in academic and scientific institutions
From where data/document is obtainable
Islamic Azad University of Qom
What processes are involved for a request to access data/document
By inserting the request in the email and replying after viewing the email