<?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>IRCT201501213989N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-03</date_registration>
      <primary_sponsor>Vice chancellor for research,Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Tetanus-diphtheria(Td) vaccine  effect  on recurrent  minor oral aphthous.</public_title>
      <acronym>Tetanus diphtheria(Td) booster vaccine effect on recovery and relapse  of  recurrent  minor oral aph</acronym>
      <scientific_title>Tetanus diphtheria(Td) booster vaccine effect on recovery and relapse  of  recurrent  minor oral aphthous.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients are not aware of the content of what they injected . The nurse injected the drug is not aware of its content. Tracking the effectiveness of treatment is not aware of the type of treatment. Statistician is unaware of the content of the treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Recurrent Aphthous stomatitis( minor).</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, one mg of oral colchicine daily for 5 days plus a booster dose of ,Tetanus diphtheria(Td) vaccine is injected right deltoid region.&#13;
 In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated. Intervention 2: In the control group one milligram oral colchicine daily for five days plus a half cc of vitamin B6 as a placebo in right deltoid area injected. In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated.</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>Sharam Habibzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit3,No 31,Alley Resalat3,Street 13 Aban</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619814398</zip>
        <telephone>+98 45 3351 4390</telephone>
        <email>s.habibzadeh@arums.ac.ir  ,shahramhabibzadeh@yahoo.com</email>
        <affiliation>Ardabil University of Medical science(ARUMS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram  Habibzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kousar Minisity,Daneshghah Street,Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618985991</zip>
        <telephone>+98 45 3352 2391</telephone>
        <email>research</email>
        <affiliation>ARUMS(Ardabil University of Medical Science)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 20 to 60 years old patients;  who have  1 to 3 minor(1-8 millimeters) oral  aphthous;  with at least one relapse per month, &#13;
&#13;
Exclusion criteria :establishment of  anemia;  HIV or Behcet's &#13;
syndrome ;   recipients  of tetanus-diphtheria(Td) vaccine in the last five years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>In the intervention group, one mg of oral colchicine daily for 5 days plus a booster dose of ,Tetanus diphtheria(Td) vaccine is injected right deltoid region.&#13;
 In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated.</i_keyword>
      <i_keyword>In the control group one milligram oral colchicine daily for five days plus a half cc of vitamin B6 as a placebo in right deltoid area injected. In case of recurrent aphthous, oral colchicine one mg daily for 5 days ,repeated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aphthous remission after treatment. Timepoint: At the beginning and end of the study. Method of measurement: Based on the  judgment of those who have studied  .Complete remission, partial remission, non-recovery.</prim_outcome>
      <prim_outcome>The interval between the occurrence of aphthous. Timepoint: 180 days. Method of measurement: One  day(24 hours).</prim_outcome>
      <prim_outcome>The number of aphthous in each recurrence. Timepoint: 180 days. Method of measurement: The number of aphthous.</prim_outcome>
      <prim_outcome>Measuring pain intensity. Timepoint: 180 days. Method of measurement: A score of 0 to ten according to one's own judgment.</prim_outcome>
      <prim_outcome>Size of aphthous. Timepoint: 180 days. Method of measurement: milimeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Injection site reactions. Timepoint: Fifteen days after injection. Method of measurement: Physical examination in case of complications.</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>Vice chancellor for research,Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-18</approval_date>
        <contact_name>Ethics committee  of Ardabil University of Medical Science</contact_name>
        <contact_address>Kousar Minisity,Daneshghah Street,Ardabil Ardabil  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
