<?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>IRCT2012103111339N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-06</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Montelukast effect in the prevention of respiratory infections</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Montelukast and  placebo in the prevention of upper respiratory infections in children 1 to 5 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>380</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11607</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Common cold.</hc_freetext>
      <i_freetext>Intervention 1: In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get montelucast(5 mg daily) oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks. Intervention 2: In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get placebo oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Fatemeh Dorreh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819691187</zip>
        <telephone>+98 86 1313 5075</telephone>
        <email>esmaelie.m@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fatemeh Dorreh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 1417 3638</telephone>
        <email>esmaelie.m@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Lack of hyper reactive airway disease;No history of allergic rhinitis;Not taking any medication for a chronic;Absence of chronic heart disease or chronic respiratory disease:&#13;
Exclusion criteria&#13;
Hyper reactive airway disease  (previously treated with bronchodilators  in the last three months, Or more than once treatment  in the past year or hospitalization for treatment or prophylaxis in recent years with Monteluckast or steroids);History of allergic rhinitis;Taking any medication for a chronic; Chronic heart disease or chronic respiratory disease;Known hypersensitivity to Montelukast;Active URI within one week ago</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute nasopharyngitis [common cold]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get montelucast(5 mg daily) oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks.</i_keyword>
      <i_keyword>In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway disease get placebo oral once a day and fills for them an information form then they followed by weekly calls.In addition, each patient Receives a record sheet of fever, rhinitis, cough, antipyretic or antibiotic use, the absence of child care and doctor visits.Each patient will be followed for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of uri attacks. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Otitis media, Pneumonia, Tonsillitis, Pharyngitis. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>The number of weeks that a child has a fever. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>The use of antibiotics or anti-fever. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>Doctor visits. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>Absences from child care. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>Absent parents. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>Hospitalization. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</sec_outcome>
      <sec_outcome>Drug reaction. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.</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>2012-06-27</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Pardis, Sardasht Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
