<?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>IRCT201502241138N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-26</date_registration>
      <primary_sponsor>Guilan University of Medical Science, Vice Chancellor for Resarch</primary_sponsor>
      <public_title>Efficacy of clotrimazole 1 ٪ and miconazole1% in otomycosis.</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of clotrimazole 1٪cream  with miconazole  1٪ cream in treatment of otomycosis-2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>otomycosis.</hc_freetext>
      <i_freetext>Intervention 1: for B acidified and miconazole cream 1% and debridement can be prescribed as creams on the ear by a ENT specialist clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal is infused cream due to the shape of the ear canal and viscosity remains within the canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse. Intervention 2: For Group C acidified and debridement with cream clotrimazole cream 1% is prescribed in the clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse. Intervention 3: For Group A, acidified and debridement is used along with a placebo .placebo will remain for a week inside the ear canal ... after a week and then placebo will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with placebo. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.</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 Hooshang Gerami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139637459</zip>
        <telephone>+98 13 3322 5242</telephone>
        <email>hg_gerami@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hooshang Gerami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139637459</zip>
        <telephone>+98 13 3322 5242</telephone>
        <email>hg_gerami@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: All patients who visit in Amir-Al.. and have a clinical diagnosis for otomycosis. Exclusion: Otitis externa along with external ear canal stenosis;a history of ear surgery;  diabetes mellitus; immunocompromise ; chronic discharging ear</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H62.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Otitis externa in mycoses</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>for B acidified and miconazole cream 1% and debridement can be prescribed as creams on the ear by a ENT specialist clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal is infused cream due to the shape of the ear canal and viscosity remains within the canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.</i_keyword>
      <i_keyword>For Group C acidified and debridement with cream clotrimazole cream 1% is prescribed in the clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.</i_keyword>
      <i_keyword>For Group A, acidified and debridement is used along with a placebo .placebo will remain for a week inside the ear canal ... after a week and then placebo will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with placebo. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fungal otitis externa. Timepoint: Weekly up to 2 week and at the end of  4th week. Method of measurement: Clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The patient's response to creams. Timepoint: Weekly up to 2 week and at the end of  4th week. 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>Guilan University of Medical Science, Vice Chancellor for Resarch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-12-30</approval_date>
        <contact_name>GuilanUniversity of Medical Sciences</contact_name>
        <contact_address>Tehran avenue Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
