<?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>IRCT20130825014472N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-31</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Ocimum Basilicium on cure Migraine</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Ocimum Basilicium oil on pain and headache in patient who has migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will achieve with using sample block method.The studied units  will be assigned to the four groups according to the criteria for inclusion in the study and available on the basis of randomized blocking. The entry of individuals to each of the groups will be done in the order of the number of selected blocks and will be done using the layout inside the block, Blinding description: Considering that one of the response variables (severity of pain) is highly dependent on the induction effects, the study is a three-point study. Also, to eliminate the effects of induction, an ophthalmic drug was used in the control group. In case of using the patient with other drugs, the patient was asked to complete the list of all used medications in the relevant form. To evaluate the outcome of the safety organization, no information was given on the dosage of medications and the expected results, so that the conditions could be genuinely evaluated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: Ocimum  Basilicum essential oil applied  locally to the forehead of the patient,  every eight hours, with doses of 2,4,6 for 6 months. Intervention 2: Control group: To preparation the drug, using liquid paraffin solvent  and the control group is  given paraffin without   ocimum basilicum 's oil .</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is عدم مشورت با همکاران در این طرح</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Ahmadifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firmaments 10, street 60m</address>
        <city>KHorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6815144312</zip>
        <telephone>+98 66 1320 0103</telephone>
        <email>mahdie.ahmadifar@yahoo.com</email>
        <affiliation>Science &amp; technology park</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parviz Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 1320 5111</telephone>
        <email>drbahrami2003@yahoo.ca</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study population of men and women with migraine headache referring to the Rahimi hospital clinic (Khorramabad-Iran)
In the period from the beginning of the second half of 2013 for a year
The upper age limit of 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have consumed oral medications - other topical medications during the past 1 month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: Ocimum  Basilicum essential oil applied  locally to the forehead of the patient,  every eight hours, with doses of 2,4,6 for 6 months.</i_keyword>
      <i_keyword>Control group: To preparation the drug, using liquid paraffin solvent  and the control group is  given paraffin without   ocimum basilicum 's oil .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severe headache. Timepoint: Before and after engaging in the second and fourth week , the second month, third month and sixth month. Method of measurement: VAS scale, Questionnaire bak, Examination physice.</prim_outcome>
      <prim_outcome>Relapse. Timepoint: Before and after engaging the second  and fourth week , the second month, third month and sixth month. Method of measurement: Questionnaire bak, Examination physice.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inside effect. Timepoint: Control in the secondand fourth week, second, third and sixthmonths. Method of measurement: According to condition and observable  clinical  trait   of patient.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-11-22</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Kamalvand Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
