<?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>IRCT20120101008585N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of Rhus Coriaria on oral aphtus stomatitis</public_title>
      <acronym>recurrent aphtus stomatitis (RAS)</acronym>
      <scientific_title>Evaluation the effect of Rhus Coriaria on pain and size of oral recurrent aphtus stomatitis in patients reffered to Shiraz Dental School</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization
Unit of randomization is individual
Tools used in randomization is flipping a coin.
head is considered as control and tail as intervention group.
allocation concealment is carring out.</study_design>
      <phase>2</phase>
      <hc_freetext>recurrent aphtus stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In experimental group the patients will receive somaq pills. The patients will use 3pills daily for 7days. By inserting the pill on the lesion, the pill itself will attach to the oral ulcer for some minute. The patient should hold this pill until it solves completely. The pills are 0.9cm in diameter. The pills was prepared by Shiraz Pharmacy Faculty. The compositions of this pill is 50% avicel, 0.2% magnesium Stearate and the remaining is somaq. Intervention 2: Control group: In the control group oral paste triadent 3 times in a day will be used. Teriadent is triamcinolone acetonide 0.1% manufactured by Raha pharma.co, Isfahan,  Iran.</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:
data related to primary outcome of pain level and size of lesion

When:
starting 6 months after publication

To whom:
people working in academic institutions
 people working in businesses

Conditions:
Statistical analysis on data is allowed.
The  applicant should email a request containing his request and the reason of his request. He should introduce himself. the data will send to him.

Where to obtain:
call Dr. Fatemeh Lavaee via lavaeef@sums.ac.ir, fatemeh.lavaee@gmail.com
Telephone: 00989177029159

How to obtain:
The  applicant should email a request containing his request and the reason of his request. He should introduce himself. the data will send to him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Lavaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr street, Ghasrdasht Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7195944315</zip>
        <telephone>+98 71 3626 3193</telephone>
        <email>lavaeef@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Lavaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr street, Ghasrdasht Ave.</address>
        <city>Shraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7195944315</zip>
        <telephone>+98 71 3626 3193</telephone>
        <email>lavaeef@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having recurrent aphtus stomatis
not using other routine prescribed medication for RAS during evaluation
less than 72 hour from emerging of the lesion
not using systemic or topical corticosteroid since 1 month ago
Patient more than 6 years old</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with other diseases related to behcet , crohn disease, rheiter syndrome or any other inflammatory disease
using analgesic mouthwash or systemic analgesia since 3 days ago
pregnant women</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: In experimental group the patients will receive somaq pills. The patients will use 3pills daily for 7days. By inserting the pill on the lesion, the pill itself will attach to the oral ulcer for some minute. The patient should hold this pill until it solves completely. The pills are 0.9cm in diameter. The pills was prepared by Shiraz Pharmacy Faculty. The compositions of this pill is 50% avicel, 0.2% magnesium Stearate and the remaining is somaq.</i_keyword>
      <i_keyword>Control group: In the control group oral paste triadent 3 times in a day will be used. Teriadent is triamcinolone acetonide 0.1% manufactured by Raha pharma.co, Isfahan,  Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: day 0,1,2,3,4,5,6,7. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Oral lesion size. Timepoint: day 0,1,2,3,,4,5,6,7. Method of measurement: measuring with ruler.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-18</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Mehr street, Ghasrdasht Ave. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
