<?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>IRCT20081109001442N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-10</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of phenytoin and triamcinolone on the minor aphthous ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of phenytoin and triamcinolone on the minor aphthous ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37145</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 patients who have been randomly assigned to numbers encoded using numbers, 30 patients using A drug(mucous adhesive phenytoin ) and 30 patients using B drug(mucous adhesive triadent), Blinding description: The ointment is divided  by the pharmacist which is not known to the patient and physician.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral aphthous ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: mucus adhesive phenytoiin oint , three times a day, for a week. Intervention 2: Intervention group:  mucus adhesive triadent oint , three times a day, for a week.</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 There is no more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasaman Sabaghzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Blvd, Shahid Sadoughi of Dental University</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>89195165</zip>
        <telephone>+98 35 3621 2222</telephone>
        <email>yasisabagh@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasaman Sabaghzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Blvd, Shahid Sadoughi of Dental University</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>89195165</zip>
        <telephone>+98 35 3621 2222</telephone>
        <email>yasisabagh@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the patient is between 20 and 40 years
Less than a day from the onset of a wound
Patient has not used any other treatment for the wound before referral
Patients agree to cooperate with this research
Patient has not systemic disease related to aphtouse lesion and there are no suspected signs of systemic disease associated with ulcers</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of other medications plus ointment for treatment
Do not use the medicine as recommended according to the patient
Missing follow up
Lesion in tonsils and 1/3 posterior of oral</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Recurrent oral aphthae</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>Intervention group: mucus adhesive phenytoiin oint , three times a day, for a week</i_keyword>
      <i_keyword>Intervention group:  mucus adhesive triadent oint , three times a day, for a week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recovery aphthous lesion. Timepoint: Evaluation of severity of pain and diameter of lesion and duration of recovery after 3 , 5 and 7 days using. Method of measurement: VAS(Visual Analogue Scale) / measuring the wound by millimeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-05</approval_date>
        <contact_name>Ethics committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Dahe fajr boulevard, shahid sadoughi of dental university Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
