<?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>IRCT20151109024975N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-01</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Zinc in improvement of Aphthous</public_title>
      <acronym>RAS</acronym>
      <scientific_title>Evaluation of the effectiveness of Zinc Sulfate mucoadhesive tablet in the improvement of Recurrent Aphthous Stomatitis (RAS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32423</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The examiner is unaware of the contents of the boxes of drugs and they are quite similar.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Recurrent Aphthous Stomoatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Patients received mucoadhesive tablets three times a day containing Zinc Sulfate (morning, afternoon and night). How to use the mucoadhesive tablets was taught to patients so that they should avoid eating and drinking for 30 minutes after applying the tablet. The chemical composition of the Zinc Sulfate mucoadhesive tablets tablet: A certain amount of Zinc Sulfate 8H20 (containing 5 mg of Zinc) was selected as a therapeutic dose to evaluate the effects of this substance on the improvement of oral Aphthous. Other components include Carbopol 940 and Sodium Alginate as a tablet binding agent to the mucus, starch as a filler to the body of the tablet, and sucrose to create the proper taste and help the pill to open gradually in the mouth. Intervention 2: Control group: Patients received mucoadhesive tablets three times a day containing Placebo (morning, afternoon and night). How to use the mucoadhesive tablets was taught to patients so that they should avoid eating and drinking for 30 minutes after applying the tablet.</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 information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anahita Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali;Asr highway</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4001</telephone>
        <email>anahita1802@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anahita Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali;Asr highway</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4001</telephone>
        <email>anahita1802@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with adequate knowledge and literacy
Age group is 16 to 45 years old
Aphthous diagnostic criteria
Ability to fill out the consent form legally</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals with major recurrent aphthous stomatitis &amp; herpetic form
Patients who had aphthous lesions in other areas than Labial &amp; Buccal mucosa
Patients with systemic disease during last month
Patients with Denture
Patients consuming antibiotics
Patients with pregnancy
Individuals with poor oral hygiene
Individuals who are not capable of receiving Zinc sulfate mucoadhesive
Individuals who have syndromes which Aphthous ulcers are one the manifestations, like Behcet's syndrome
Individuals who are prescribed a non-Zinc drug for Aphthous improvement
Smoking Individuals
Individuals who consume Immunosuppressive drug during last month
Individuals who couldn't resume the study according to social or  personal issues</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Patients received mucoadhesive tablets three times a day containing Zinc Sulfate (morning, afternoon and night). How to use the mucoadhesive tablets was taught to patients so that they should avoid eating and drinking for 30 minutes after applying the tablet. The chemical composition of the Zinc Sulfate mucoadhesive tablets tablet: A certain amount of Zinc Sulfate 8H20 (containing 5 mg of Zinc) was selected as a therapeutic dose to evaluate the effects of this substance on the improvement of oral Aphthous. Other components include Carbopol 940 and Sodium Alginate as a tablet binding agent to the mucus, starch as a filler to the body of the tablet, and sucrose to create the proper taste and help the pill to open gradually in the mouth.</i_keyword>
      <i_keyword>Control group: Patients received mucoadhesive tablets three times a day containing Placebo (morning, afternoon and night). How to use the mucoadhesive tablets was taught to patients so that they should avoid eating and drinking for 30 minutes after applying the tablet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diameter of eritmathous halo. Timepoint: Zero (before entering the study); third; fifth and seventh days. Method of measurement: Metal caliber.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Period of improvement. Timepoint: Zero (before entering the study); third; fifth and seventh days. Method of measurement: Visual Analogue Scale Questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-24</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vali;Asr highway Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
