<?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>IRCT20161103030680N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-11</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Migraine in menstrual period</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of acetazolamide efficacy in migraine headaches in menstrual period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with migraine headache  who attend in neurology clinic  of Mostafa Khomeini hospital  and are selected according to study criteria are given a number and then by use of chart of random numbers are assigned randomly in study and control groups. The group of first patient is selected by lottery, Blinding description: ِDrugs are inserted in uniform packages and code is assigned. Patients researchers and assessors  are not aware of patient group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Migraine headaches. Condition 2: Migraine headaches.</hc_freetext>
      <i_freetext>Intervention 1: Control group:Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months.  َAll patients in this group takes  placebo three times daily from three days prior the usual time of menstrual period for each patient to the end of period in addition to above mentioned drugs. Intervention 2: Intervention group: Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months. ََAll patients in this group take Acetazolamide  two hundred and fifty milligrams three times daily from three days before the usual time for beginning of menstrual period to the end of period in addition to above mentioned drugs.</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 I am not sure about ethical problems from aspect of patients.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Siamak Afshinmajd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Italia street. Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643491</zip>
        <telephone>+98 21 8896 9438</telephone>
        <email>safshinmajd@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak Afshinmajd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Italia street. Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643491</zip>
        <telephone>+98 21 8896 9438</telephone>
        <email>safshinmajd@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Migraine headaches according to International headache society criteria
At least one year history of migraine headaches
At least three attacks of headaches in one month
Exacerbation  of headaches during menstrual periods
Age between eighteen to forty-five years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of any other drugs at the beginning of study
Other types of headaches or facial pain
Intolerance or allergy to drugs which are used in study
Abnormal neurologic exam which is unacceptable in migraine
Menstrual period shorter than five days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
      <hc_code>G43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura (common migraine)</hc_keyword>
      <hc_keyword>Migraine with aura (classic 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>Control group:Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months.  َAll patients in this group takes  placebo three times daily from three days prior the usual time of menstrual period for each patient to the end of period in addition to above mentioned drugs</i_keyword>
      <i_keyword>Intervention group: Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months. ََAll patients in this group take Acetazolamide  two hundred and fifty milligrams three times daily from three days before the usual time for beginning of menstrual period to the end of period in addition to above mentioned drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache Intensity. Timepoint: Third day after beginning of treatment  with acetazolamide and fifth day of menstruation in both groups. Method of measurement: Visual Analougue Scale.</prim_outcome>
      <prim_outcome>Headache duration. Timepoint: At first day before beginning of treatment and at the end of each treatment episode. Method of measurement: Mean duration of attacks in hour according to patients claims.</prim_outcome>
      <prim_outcome>Headache Intensity. Timepoint: Third day after beginning of treatment and fifth day of menstruation. Method of measurement: 6 Points Behavioral Rating Scale.</prim_outcome>
      <prim_outcome>Headache frequency. Timepoint: At first day before beginning of treatment and at the end of each treatment episode. Method of measurement: Number of headache attacks.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergic drug reactions (Pruritus, Redness of skin, Urticaria). Timepoint: Instantly after alarm of the patient. Method of measurement: Observation, examination and consultation with proper specialist.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-10</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Entrance of Tehran - Qom Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
