<?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>IRCT2013121715655N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-27</date_registration>
      <primary_sponsor>Tehran University Of Medical Sciences</primary_sponsor>
      <public_title>Effects of Methotrexate on oral lichen planus</public_title>
      <acronym></acronym>
      <scientific_title>Assesment of the efficacy of methotrexate on patients with oral lichen planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14867</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lichen planus.</hc_freetext>
      <i_freetext>In this study, in the first week, 7.5 mg methotraxate per week (three tablets, 2.5 milligrams) plus 1mg folic acid per day will be administered and from the next week, 15 mg per week plus 1mg folic acid per day  in condition of tolerance will be administered.  Treatment duration is 12 weeks. In each visit, each patient will be evaluated for leukopenia, anemia, thrombocytopenia, liver function and kidney function..</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>Zahra Shafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital, Vahdat Eslami st, Vahdat Eslami square, Hafez st, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 9951</telephone>
        <email>lajevardi@tums.ac.ir;  ze_1367@yahoo.com</email>
        <affiliation>Razi Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahide Lajevardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital, Vahdat Eslami st, Vahdat Eslami Square, Hafez st, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 9951</telephone>
        <email>lajevardi@tums.ac.ir; vahide_lajevardi@yahoo.com</email>
        <affiliation>Razi Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with oral lichen planus, diagnosed by clinical and pathological criteria, who did not respond to topical therapy.&#13;
 Exclusion criteria: Pregnancy and breast feeding; cancer; severe and frequent infections;  Hereditary or acquired immunodeficiency; leukopenia; anemia; thrombocytopenia; hepatic dysfunction; Stomach ulcers; dysplastic lesions in pathology; ulcerative colitis disease; side effects of methotraxate</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other lichen planus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, in the first week, 7.5 mg methotraxate per week (three tablets, 2.5 milligrams) plus 1mg folic acid per day will be administered and from the next week, 15 mg per week plus 1mg folic acid per day  in condition of tolerance will be administered.  Treatment duration is 12 weeks. In each visit, each patient will be evaluated for leukopenia, anemia, thrombocytopenia, liver function and kidney function.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The resolution of oral lesions. Timepoint: Before treatment and at two, four, eight and twelve weeks. Method of measurement: Thongprasom Scale.</prim_outcome>
      <prim_outcome>Pain reduction. Timepoint: Before treatment and at weeks two, four, eight and twelve. Method of measurement: VAS ( Visual Analog Scale) Pain was scored from zero to ten.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The side effects of methotraxate. Timepoint: First, fourth, eighth and twelfth week. Method of measurement: Examination in each visit.</sec_outcome>
      <sec_outcome>The Size of lesions. Timepoint: First, fourth, eighth and twelfth week. Method of measurement: Transparent grid ( mm ).</sec_outcome>
      <sec_outcome>Duration of disease since diagnosis. Timepoint: Before treatment. Method of measurement: Interview.</sec_outcome>
      <sec_outcome>The type of lesion (ulcerative , reticular , atrophic). Timepoint: Before treatment. Method of measurement: previous records.</sec_outcome>
      <sec_outcome>The  location of lesions  (bucal , gingival , palatine). Timepoint: Before treatment. Method of measurement: previous records.</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>Tehran University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-01</approval_date>
        <contact_name>Research Ethics Committee at Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Tehran University of Medical Sciences, Ghods st, Keshavarz blvd, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
