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IRCT20210626051718N1 IRCT 2021-07-15 Arak University of Medical Sciences The effect of montelukast in treatment of Pollakiuria Evaluation the effect of Montelukast on urinary symptoms in children with pollakiuria 2021-08-01 anticipated 64 Complete https://irct.ir/trial/57132 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, 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. 2 Pollakiuria (The daytime urinary frequency syndrome). Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All of the indivisual data of participants When: The access period stars immediately aftter publishing the results. To whom: The informations will be available for any researcher. Conditions: There is no limitation Where to obtain: 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 How to obtain: 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. Comments:
public Hamideh Bakhtiari
Hazrat masoome dormitory,University union,Sardasht,Arak
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 26 4534 4302 hamide.bakhtiari@gmail.com Arak University of Medical Sciences scientific Hamideh Bakhtiari
Hazrat masoome dormitory,University union,Sardasht,Arak
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 26 4534 4302 hamide.bakhtiari@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 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 3 years 18 years Both Allergiy history to Montelukast R35.0 Frequency of micturition Treatment - Drugs Treatment - Drugs 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. 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. 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. Arak University of Medical Sciences Approved 2021-06-13 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, University complex of Payambare Azam, Sardasht Arak Markazi Iran (Islamic Republic of)