<?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>IRCT201311101760N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-22</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</primary_sponsor>
      <public_title>The Efficacy of the Mucoadhesive Patch and Mouthwash Containing Zingiber Officinale Extract in the Management of Recurrent Aphthous Stomatitis</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of the Mucoadhesive Patch and Mouthwash Containing Zingiber Officinale Extract in the Management of Recurrent Aphthous Stomatitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1291</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Oral Mucositis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:&#13;
  During three aphthous are studied.The first blow to fall markedly during registration per person and two other courses of treatment with a mouthwash (Ethanol, 96% ethanol extract of Zingiber with ml 500 gr 300. Ginger powder is prepared in the laboratory of Pharmacology, Babol University of Medical Sciences.)containing ginger(Dried extract prepared at a concentration of 4%) are studied.    &#13;
  How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.&#13;
 How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined. Intervention 2: Control(placebo):     &#13;
Based mouthwash (distilled water as a mouthwash base);Mucosal Adhesive Base (including gum (tragacanth), alcohol, sodium benzoate, and distilled water was prepared in the laboratory of Pharmacology, Babol University of Medical Sciences) for use sticky mucus and rinse in the day (after each meal and before bedtime) to for 20 minutes.&#13;
  How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.&#13;
 How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined.</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>Dr. Masoomeh Haghpanah Aski</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental College, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1229 1408</telephone>
        <email>parya_haghpanah@yahoo.com</email>
        <affiliation>Dental College of Babol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mina Motallebnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental College of Babol, Babol University of Medical Sciences, Gangafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1222 7667</telephone>
        <email>mmotallebnejad@yahoo.com</email>
        <affiliation>Dental College of Babol</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterion: minor pest record over the last 2 months.&#13;
Exclusion criterion: major and several minor aphthous ulcers or sores in other areas of the mucosa, lips and cheeks.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis</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:&#13;
  During three aphthous are studied.The first blow to fall markedly during registration per person and two other courses of treatment with a mouthwash (Ethanol, 96% ethanol extract of Zingiber with ml 500 gr 300. Ginger powder is prepared in the laboratory of Pharmacology, Babol University of Medical Sciences.)containing ginger(Dried extract prepared at a concentration of 4%) are studied.    &#13;
  How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.&#13;
 How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined.</i_keyword>
      <i_keyword>Control(placebo):     &#13;
Based mouthwash (distilled water as a mouthwash base);Mucosal Adhesive Base (including gum (tragacanth), alcohol, sodium benzoate, and distilled water was prepared in the laboratory of Pharmacology, Babol University of Medical Sciences) for use sticky mucus and rinse in the day (after each meal and before bedtime) to for 20 minutes.&#13;
  How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.&#13;
 How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Minor aphthous ulcers. Timepoint: Seventh-day visit. Method of measurement: Clinical.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lesion diameter. Timepoint: Zero, first, third, fifth and seventh days of referral. Method of measurement: clinical.</sec_outcome>
      <sec_outcome>Inflammatory halo size. Timepoint: Zero, first, third, fifth and seventh days of referral. Method of measurement: clinical.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Zero , first, third, fifth and seventh days of referral. Method of measurement: Visual Analoge Scale(VAS).</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 and Technology, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-15</approval_date>
        <contact_name>The ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafroz Road Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
