<?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>IRCT201511257297N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-12</date_registration>
      <primary_sponsor>shiraz university of medical science</primary_sponsor>
      <public_title>topical rose oil in the patients with migraine headache</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and side effects of topical rose oil in the treatment of acute migraine headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/7745</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: basic demographic of patients, basic demographic of their headache, pain intensity of patients based on VAS  before use and till 24hr after use of drug or placebo, intensity of their headache features such as nausea/vomiting,get away of light( photophobia), get away of sound with use of drug or placebo for 2hr, pain intensity in cold and hot temperament  patients after use the drug or placebo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>migraine headache.</hc_freetext>
      <i_freetext>Intervention 1: essential rose oil  as a drug, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period. Intervention 2: Liquid paraffin as a placebo, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period.</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>Maria Niazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Shiraz, Zand street,Shiraz University of Medical Science</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134845794</zip>
        <telephone>+98 71 3230 5886</telephone>
        <email>maria_niazi98@yahoo.com</email>
        <affiliation>shiraz university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Heidary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran ,shiraz,zand street, shiraz university of medical science</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134845794</zip>
        <telephone>+98 71 3233 7589</telephone>
        <email>meshkat_114@yahoo.com</email>
        <affiliation>shiraz university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:patients with migraine headache based on 3th edition of IHS and ICHD criteria, age over 18 years, having at least 2 migraine headache every months. exclusion criteria:sensitivity to rose flowersl, pregnancy, don't sign informative testimonial, getting worse headache intensity with olphactory stimulation of drug or placebo, new diagnosed case with indication of preventive therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.0 and </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>migraine without aura(common migraine) and migraine with aura(classical migraine)</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>essential rose oil  as a drug, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period</i_keyword>
      <i_keyword>Liquid paraffin as a placebo, 7cc, almost 2cc in every attack used topical in temporal and frontal area, interval of attacks was minimum 1 week as washout period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: 0 min, 15min, 30 min, 45 min, 60 min, 90 min, 120 min, 6 hr, 12 hr, 24hr. Method of measurement: visual analogue scale of pain(VAS).</prim_outcome>
      <prim_outcome>Photophobia. Timepoint: 0 min, 30 min, 2hr. Method of measurement: visual analogue scale of pain(VAS).</prim_outcome>
      <prim_outcome>Nausea/vomiting. Timepoint: 0 min, 30 min, 2hr. Method of measurement: visual analogue scale of pain(VAS).</prim_outcome>
      <prim_outcome>Get away of sound. Timepoint: 0 min, 30 min, 2hr. Method of measurement: visual analogue scale of pain(VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any adverse reaction to the intervention. Timepoint: 0min, 15min, 30min,45min, 60min, 90min, 120min, 6hr, 12hr, 24hr. Method of measurement: visual analogue scale of pain(VAS).</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>shiraz university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-08</approval_date>
        <contact_name>Shiraz University of Medical Science</contact_name>
        <contact_address>Shiraz, Zand street, shiraz university of medical sciense Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
