<?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>IRCT20161103030680N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-28</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Efficacy of Pregabaline on Trigeminal Neuralgia</public_title>
      <acronym></acronym>
      <scientific_title>Compare of The  efficacy of Pregabaline and Carbamazepine on patients with  Trigeminal Neuralgia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24302</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: All selected  samples are given one number and then are assigned in two groups alternatively by use of random number chart. group one take Pregabaline for thirty days and group two take Carbamazepine for the same period. After five days interval without any drug patients in group one take Carbamazepine and patients in group two take Pregabaline for the same 
period. Selection of group for the first patient is by lottery, Blinding description: All drugs are inserted in uniform packages and mark by specific code . Drugs are given to patients in the way that,participitants ,main researchers and assessors of signs and symptoms from all groups such as physicians or students are not aware of patient 's group and the kind of drugs. Study design and steps are explained for all patients but they are not aware of their group and drug kind which started for them.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Trigeminal Neuralgia.</hc_freetext>
      <i_freetext>Intervention 1: First group: Ten patients who assigned randomly in this group take Pregabaline seventy-five milligrams two times daily for thirty days. After five days interval without any drug these patients take Carbamazepine two hundred milligrams every twelve hours for thirty days. Intervention 2: First group: Ten patients who assigned randomly in this group take Carbamazepine two hundred milligrams two times daily for thirty days. After five days interval without any drug these patients take Pregabaline seventy five milligrams  two times daily for thirty days.</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 benefits and patients rights from ethical aspect</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Siamak Afshinmajd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entrance of Tehran- Qom highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 5080</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>Age between eighteen to seventy-five years old.
Suffering from Idiopathic Trigeminal neuralgia according to International Headache Society criteria.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from other kinds of head and facial pain
History of psychiatric diseases, Renal failure, liver failure, Heart failure, Thrombocytopenia, Leuckopenia, Anemia and malignancy
Pregnancy and Breast feeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trigeminal neuralgia</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>First group: Ten patients who assigned randomly in this group take Pregabaline seventy-five milligrams two times daily for thirty days. After five days interval without any drug these patients take Carbamazepine two hundred milligrams every twelve hours for thirty days.</i_keyword>
      <i_keyword>First group: Ten patients who assigned randomly in this group take Carbamazepine two hundred milligrams two times daily for thirty days. After five days interval without any drug these patients take Pregabaline seventy five milligrams  two times daily for thirty days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neuralgic pain intensity. Timepoint: Before starting the drugs and from days twenty- eight to thirtieth in each period. Method of measurement: Visual Analogue scale (VAS).</prim_outcome>
      <prim_outcome>Neuralgic pain intensity. Timepoint: Before starting the drugs and from days twenty- eight to thirtieth in each period. Method of measurement: 5 points verbal rating scale.</prim_outcome>
      <prim_outcome>Duration of neuralgic pain. Timepoint: Before starting the drugs and from days twenty- eight to thirtieth in each period. Method of measurement: Average duration of attacks in seconds.</prim_outcome>
      <prim_outcome>Frequency of neuralgic pain. Timepoint: Before starting the drugs and from days twenty- eight to thirtieth in each period. Method of measurement: Number of attacks in one day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Unpredictable drug reactions (Pruritus, Burning sensation, Skin redness). Timepoint: immediately after patient alarm. Method of measurement: Observation, Examination, and refer to the specialist.</sec_outcome>
      <sec_outcome>Drowsiness. Timepoint: Immediately after patient alarm. Method of measurement: Observation, examination, and refer to the 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>2015-11-16</approval_date>
        <contact_name>Ethical 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>
