1.Determining the frequency of daily urination in "Receiving Montelukast" group before and after intervention
2. Determining the frequency of daily urination in control group before and after receiving the routine treatment
3.Comparing the frequency of daily urination in the two groups before and after intervention
Design
Randomized clinical trial with control group, on 64 patients. The randomization will be performed by using quadruple blocks which is produced by statistical software
Settings and conduct
The diagnosis will be confirmed by normal U/A, U/C and kidney and urinary tract's sonography. These children will allocated to equal "case" and "control" groups by using randomization methods. At the beginning and end of the 14days of treatment, we will ask the mothers about the urinary symptoms and will note the information in check lists. The study will be performed in Amir Kabir hospital of Arak city.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1.Children aged 3-18 years with pollakiuria who referred to pediatric clinic of Amir Kabir hospital of Arak
2. Children aged 3-18 years with pollakiuria who hospitalized in wards of Amir Kabir hospital of Arak
3. Having the allergy history
Criteria for non-entry to study:
1. History of allergy to Montelukast
Intervention groups
In the receiving Montelukast group Montelukast chewable tablets 5 mg/d are prescribed for 14days in 3-15 years old children and 10mg/d for children older than 15 years old.
The both "case" and "control" groups will receive the routine treatment of pollakiuria which is Oxybutynin tablets 5mg.The tablets are prescribed as follows. 0.2mg/kg/dose q12hours in children younger than 5 years old for 14 days (Max dose:15mg/24h ) and 5mg/dose q12 h in children older than 5 years old ( Max dose: 20mg/24h).
Main outcome variables
frequency of daytime urination before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210626051718N1
Registration date:2021-07-15, 1400/04/24
Registration timing:prospective
Last update:2021-07-15, 1400/04/24
Update count:0
Registration date
2021-07-15, 1400/04/24
Registrant information
Name
Hamideh Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 4534 4302
Email address
hamide.bakhtiari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Montelukast on urinary symptoms in children with pollakiuria
Public title
The effect of montelukast in treatment of Pollakiuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children with pollakiuria aged 3-18 years referred to the pediatric clinic of Amirkabir Hospital in Arak
Children with pollakiuria aged 3-18 years who were hospitalized in the pediatric wards of Amirkabir Hospital in Arak
History of allergy
Exclusion criteria:
Allergiy history to Montelukast
Age
From 3 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are allocated to two groups by block randomization method in which the allocated patients to each group will be equal.In this clinical trial we will use quadruple blocks( consists of 2applicants of case-group and 2 applicants of control-group). These are produced by random allocation software. The concealment is guaranteed by concealing the random allocation with sequentially numbered, sealed, opaque envelopes that the allocated group should not be specified before the individual is assigned.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, University complex of Payambare Azam, Sardasht
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.ARAKMU.REC.1400.054
Health conditions studied
1
Description of health condition studied
Pollakiuria (The daytime urinary frequency syndrome)
ICD-10 code
R35.0
ICD-10 code description
Frequency of micturition
Primary outcomes
1
Description
frequency of daytime urination
Timepoint
First at the beginning of the study and then after 14days of receiving treatment
Method of measurement
After 14 days of treatment,the frequency of daytime urination and the exact day which the symptoms had improved will be asked from mothers.Then these information will be noted in check list.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Montelukast chewable tablets 5 mg/d are prescribed for 14days in 3-15 years old children and 10mg/d for children older than 15 years old.This tablet is produced by Dr. Abidi 's pharmaceutical company, Tehran, Islamic republic of Iran.Oxybutynin tablets 5mg as a routine treatment will be prescribed.The tablets are prescribed as follows. 0.2mg/kg/dose q12hours in children younger than 5 years old for 14 days (Max dose:15mg/24h ) and 5mg/dose q12 h in children older than 5 years old ( Max dose: 20mg/24h).This tablet is produced by Iran Daru pharmaceutical company, Tehran, Islamic republic of Iran.
Category
Treatment - Drugs
2
Description
Control group: Oxybutynin tablets 5mg as a routine treatment will be prescribed.The tablets are prescribed as follows. 0.2mg/kg/dose q12hours in children younger than 5 years old for 14 days (Max dose:15mg/24h ) and 5mg/dose q12 h in children older than 5 years old ( Max dose: 20mg/24h).This tablet is produced by Iran Daru pharmaceutical company, Tehran, Iran.
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All of the indivisual data of participants
When the data will become available and for how long
The access period stars immediately aftter publishing the results.
To whom data/document is available
The informations will be available for any researcher.
Under which criteria data/document could be used
There is no limitation
From where data/document is obtainable
Hamide bakhtiari via email: hamide.bakhtiari @gmail.com
Dr.parsa Yousefichaijan via email:parsayousefichaijan@gmail.com
Dr.Fatemeh Dorre via email:fatemeh_dorre@yahoo.com
Dr.Ali Arjmand via email:aliarjmand1@yahoo.com
What processes are involved for a request to access data/document
The applicant send his request via email.He should introduce himself completely and mention why he needs the information.Then the data will send back by email.