<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210628051728N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-08</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Montelukast on symptoms of children with bladder pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of Montelukast on urinary symptoms in children with bladder pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57171</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For dividing patients into two groups block randomization method will be used.This method is used for making balance in allocated cases.The epidemiologist will create randomization sequences by using quadruple blocks(Two cases from control group and two cases from case group) that are produced by the assist of sealed envelope online site and will allocate patients to two groups.As soon as a patient enters the project its status will be determined so the concealment process will be guaranteed.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Bladder pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Montelukast chewable tablet 5mg in 3-15 year children,10mg in older than 15 year children daily for 14days.This tablet is made in Iran,Dr Abidi pharmaceutical company.Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year  old children.It is made in Iran,Iran Daru  pharmaceutical company. Intervention 2: Control group: Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year  old children.It is made in Iran,Iran Daru  pharmaceutical company.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the individual data of participants

When:
The access period starts immediately after publishing the results

To whom:
The information will be available for any researcher.

Conditions:
There is no limitation.

Where to obtain:
Faezeh Akbarzadeh via faezeakbarzadeh@yahoo.com / Dr.Ali Arjmand via aliarjmand1@yahoo.com  /Dr.Fatemeh Dorreh via fatemeh_dorre@yahoo.com/ Dr.Parsa Yousefi via  parsayousefichaijan@yahoo.com

How to obtain:
The applicant must send his request via email while introducing himself and his reason for information access .Then the data will be sent back by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 6055</telephone>
        <email>faezeakbarzadeh@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faezeh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>faezeakbarzadeh@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All 3-18 year old children with bladder pain syndrome who were referred to Amirkabir hospital pediatric clinic of Arak city
All 3-18 year old children with bladder pain syndrome who were admitted to Amirkabir hospital ward of Arak city
Allergy history</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy history to Montelukast</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R39.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other symptoms and signs involving the genitourinary system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Montelukast chewable tablet 5mg in 3-15 year children,10mg in older than 15 year children daily for 14days.This tablet is made in Iran,Dr Abidi pharmaceutical company.Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year  old children.It is made in Iran,Iran Daru  pharmaceutical company.</i_keyword>
      <i_keyword>Control group: Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year  old children.It is made in Iran,Iran Daru  pharmaceutical company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease nocturia. Timepoint: days0-14. Method of measurement: questionnaire(numbers).</prim_outcome>
      <prim_outcome>Alleviate bladder pain. Timepoint: days0-14. Method of measurement: questionnaire(mild/moderate/severe).</prim_outcome>
      <prim_outcome>Decrease urinary Incontinency. Timepoint: days 0-14. Method of measurement: questionnaire(numbers).</prim_outcome>
      <prim_outcome>Decrease urinary urgency. Timepoint: days 0-14. Method of measurement: questionnaire(numbers).</prim_outcome>
      <prim_outcome>Decrease urinary frequency. Timepoint: days 0-14. Method of measurement: questionnaire(numbers).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-12</approval_date>
        <contact_name>Ethics commitee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
