<?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>IRCT201312161059N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-11</date_registration>
      <primary_sponsor>Science Medical Vice chancellor for research, Pasteur Institute of Iran</primary_sponsor>
      <public_title>Efficacy evaluation of pomegranate peel extract in oral candidiasis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  Pomegranate peel extract anticandidal activity and  nystatin  in patients with oral candidiasis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This randomized clinical trial will be conducted between 22 May 2014 and 19 February 2015, comparing the effectiveness of pomegranate peel extract and nystatin in patients with oral candidiasis. After assessment of eligibility, sixty subjects will be included in this study. After the initial assessment patients by using the random number tables, will be randomly assigned to either an intervention group or a control-group. After randomization by using the random number tables, the two groups of subjects are followed in exactly the same way.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Oral Candidiasis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Pomegranate (Punica granatum L.) peel extract gel. The oral gel contains pomegranate peel extract.  It will be prepare in Jaber Ebne Hayyan Pharmaceutical  Company in 40 ml tubes and it will be use topical three times per day for 14 days. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for pomegranate peel extract topical application. Intervention 2: Intervention 2: Nystatin&#13;
  The nystatin level is 1.72% w/w. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for nystatin topical application. It will be prepare in Jaber Ebne Hayyan Pharmaceutical Company in 40 ml tubes and it will be use topical three times per day for 14 days.</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>Shahindokht Bassiri-Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.69, 12th Farwardin, Pasteur St. Medical Mycology Department, Pasteur Institute of Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1316943551</zip>
        <telephone>+98 21 6695 3311</telephone>
        <email>basiri@pasteur.ac.ir; bassirishahindokht@yahoo.com</email>
        <affiliation>Pasteur Institute of Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad R Pourshafie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.69, 12th  Farwardin St., Pasteur St. Microbiology Department, Pasteur Institute of Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1316943551</zip>
        <telephone>+98 21 6695 3311</telephone>
        <email>pour62@pasteur.ac.ir</email>
        <affiliation>Pasteur Institute of Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patients who have oral candidiasis. Exclusion criteria: The patients who unable to provide informed consent, may not adhere to treatment or may not complete follow up.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B 37.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Candidal stomatitis/Oral thrush</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 1: Pomegranate (Punica granatum L.) peel extract gel. The oral gel contains pomegranate peel extract.  It will be prepare in Jaber Ebne Hayyan Pharmaceutical  Company in 40 ml tubes and it will be use topical three times per day for 14 days. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for pomegranate peel extract topical application.</i_keyword>
      <i_keyword>Intervention 2: Nystatin&#13;
  The nystatin level is 1.72% w/w. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for nystatin topical application. It will be prepare in Jaber Ebne Hayyan Pharmaceutical Company in 40 ml tubes and it will be use topical three times per day for 14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Presence of fungal infections. Timepoint: before intervention, one week after intervention and end of intervention. Method of measurement: Clinical examinations of oral lesion, fungal laboratory direct and culture examination of oral lesion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Presence of side effect. Timepoint: One week and two weeks after intervention. Method of measurement: Clinical  examination.</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>Science Medical Vice chancellor for research, Pasteur Institute of Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-10</approval_date>
        <contact_name>Sciences Ethics committee of Pasteur Institute of Iran</contact_name>
        <contact_address>No. 69,12th  Farwardin St., Pasteur St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-26</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sience, Research institute of Immunology, Asthma &amp; </contact_name>
        <contact_address>No. 62, Dr. Gharib St, Keshavarz Blvd., Immunology, Asthma and Allergy Research Institute, Children's Medical Center, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
