<?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>IRCT138711011570N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-09-26</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences, Applied Physiology Research Center</primary_sponsor>
      <public_title>Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Enalapril, 5 mg tablet, twice a day for 2 months. Intervention 2: Oral placebo tablet, twice a day for 2 months.</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>Shaghayegh Haghjooi-e-javanmard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences,Applied physiology research center</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone></telephone>
        <email>shaghayeghhaghjoo@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shaghayegh Haghjooi-e-javanmard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences,Applied physiology research center</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745</zip>
        <telephone>+98 31 1792 2295</telephone>
        <email>shaghayeghhaghjoo@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: having more than three migraine attacks per month during the last 3 months,  having more than 3 migraine attacks during the baseline period,  debut of migraine at least one year prior to study, start of migraine before age 50 years&#13;
Exclusion Criteria: Having cardiovascular (endothelial dysfunction) risk factors,  undistinguishable headache interval from migraine, chronic tension-type headache or other headache occurring on more than 15 days per month, pregnancy, breast feeding, inability to use contraceptives, presence of heart conduction block on ECG or significant ECG abnormality, presence of current or previous asthma, diabetes, decreased hepatic or renal function, hypersensitivity to active substance, significant psychiatric illness, use of daily migraine prophylactics less than 4 weeks prior to study, having tried more than or equal to three prophylactic drugs against migraine during the last 10 years, previous use of Enalapril in adequate doses, previous discontinuation of Enalapril due to side effects, current use of antihypertensive medication, subjects requiring detoxification from acute medication (Ergotamines, Opioids), consistently failure to respond to any acute migraine medication, alcohol or illicit drug dependence</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the nervous system/Episodic and paroxysmal disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Enalapril, 5 mg tablet, twice a day for 2 months</i_keyword>
      <i_keyword>Oral placebo tablet, twice a day for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical status improvement. Timepoint: before intervention/1 month later/2 months later. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Endothelial dysfunction recovery. Timepoint: before intervention/2 months later. Method of measurement: FMD with high resolution Bmode Ultrasonographic system/NOx with Greiss method/CRP with ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache frequencies. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Headache durations. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Headache severity. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>FMD Index. Timepoint: Before intervention,2 months later. Method of measurement: High resolution Bmode Ultrasonography.</sec_outcome>
      <sec_outcome>Level of CRP. Timepoint: Before intervention,2 months later. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>NOx. Timepoint: before intervention,2 months later. Method of measurement: Greiss method.</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>Isfahan University of Medical Sciences, Applied Physiology Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-12-09</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Applied physiology research center, Isfahan University of Medical Sciences, Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
