<?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>IRCT20191012045067N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-01</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of sumac spray on minor  recurrent aphthous stomatitis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of sumac spray on minor  recurrent aphthous stomatitis treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Other design features: effectiveness of somac in the treatment of patients with recurrent aphthous stomatitis, Blinding description: patient and analyzer don't know about drugs and placebo also which one is drug and which one is placebo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>recurrent aphthous stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Intervention group: People with recurrent aphthous ulcer somac spray 4 times a day for 5 days (The patient asked to use the spraay four times a day (one hour before meals and twenty minutes before bedtime) for five days and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug). Intervention 2: Control group: Control group: People with recurrent aphthous ulcer use placebo 4 times a day for 5 days (The patient asked to use the spray containing essence (placebo) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug). Intervention 3: Intervention group: Intervention group: People with recurrent aphthous ulcer use corticosteroid 4 times a day for 5 days(The patient asked to use the orabase containing corticosteroid (triamcinolone) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
manuscript

When:
2 year

To whom:
researcher

Conditions:
treatment

Where to obtain:
internal site

How to obtain:
search

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoomeh Shirzaiy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3344 1824</telephone>
        <email>Shirzaiy@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Shirzaiy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3344 1824</telephone>
        <email>Shirzaiy@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The existence of 1-5 wounds less than 24h
its size of less than 10mm (if there is more than one wound, the average diameter of all wounds will prevail)the pain existence in the affected area
the age above 18 years
lack of history of  drug hypersensitivity
non pregnant and no lactation
Lack of history of systemic disease
Lack of  non-steroid anti-inflammatory medication or oral antihistamines use one month before  the study entrance
lack of treatment with systemic or immunosuppressive medications a month before  the study entrance
treatment of wounds with each drug before  study entrance
lack of treatment with systemic antibiotics 2weeks before the study entrance
the absence of aphthea ulcer  adjacent trauma ulcers caused by sharp tooth edges, broken restorative  , orthodontic appliance or partial denture prosthesis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No attend of person with recurrent aphthous stomatitis in fallow up period
non-controlled diabetes
non-controlled hypertension
pregnancy or lactation
active or known infection
severe mental disorder
require of treatment with antibiotics during the desired treatment</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Intervention group: People with recurrent aphthous ulcer somac spray 4 times a day for 5 days (The patient asked to use the spraay four times a day (one hour before meals and twenty minutes before bedtime) for five days and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)</i_keyword>
      <i_keyword>Control group: Control group: People with recurrent aphthous ulcer use placebo 4 times a day for 5 days (The patient asked to use the spray containing essence (placebo) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)</i_keyword>
      <i_keyword>Intervention group: Intervention group: People with recurrent aphthous ulcer use corticosteroid 4 times a day for 5 days(The patient asked to use the orabase containing corticosteroid (triamcinolone) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recurrent aphthous stomatitis. Timepoint: Day Zero, second, seventh after the start of treatment. Method of measurement: Visual Analogue Scale,Periodontal probe.</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>Vice Chancellor for Research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-19</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Azadegan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
