<?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>IRCT20210823052264N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-19</date_registration>
      <primary_sponsor>PNS SHIFA</primary_sponsor>
      <public_title>Efficacy of oral voriconazole versus itraconazole in the treatment of dermatophyte infections</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of oral voriconazole versus oral itraconazole in the treatment of dermatophyte infections</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen, Blinding description: In this study, the participant, the investigator and outcome assesor were all blinded except for one physician who was supposed to recruit the patients in the group. As explained above the participants will be asked to pick up a chit of paper from a jar that will decide in which group they will fall into. The participants will not open the chit themselves, but will hand it over to the non blinded accessor, who will give them the medicine without any label showing the brand or generic name.</study_design>
      <phase>3</phase>
      <hc_freetext>Dermatophyte infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In group "A" patietns were treated with Tab Voriconazole 200mg twice a day for four weeks or less in patients in which clinical response is achieved. Intervention 2: Intervention group: In group "B" patients were treated with Tab Itraconazole 100md twice daily for four weeks or less in which clinical response is achieved.</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:
Primary outcome

When:
1 month after the trial and for lifetime

To whom:
People working in academic institutions

Conditions:
Many

Where to obtain:
mairasmuian2012gmail.com

How to obtain:
Request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maira Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Maira Ali, 5th Floor, OPD Tower, PNS Shifa Hospital</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>74900</zip>
        <telephone>+92 21 48506592</telephone>
        <email>mairasmuian2012@gmail.com</email>
        <affiliation>PNS Shifa</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maira Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Maira Ali, 5th Floor, OPD Tower, PNS Shifa Hospital</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>74900</zip>
        <telephone>+92 21 48506592</telephone>
        <email>mairasmuian2012@gmail.com</email>
        <affiliation>PNS SHIFA</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic and recurrent dermatophyte infections (chronic refers to infections present for over 6 months, recurrent refers to patients with an infection in which symptoms reappear in 6 weeks after complete cure or stopping of treatment).</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with age less than 15 and greater than 90 years,
Hyperlipidemia,
Abnormal liver and renal function tests, 
Pregnant and breast feeding females.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dermatophytosis</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 group "A" patietns were treated with Tab Voriconazole 200mg twice a day for four weeks or less in patients in which clinical response is achieved</i_keyword>
      <i_keyword>Intervention group: In group "B" patients were treated with Tab Itraconazole 100md twice daily for four weeks or less in which clinical response is achieved</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical response based on clearence of lesion and absence of fungal hyphae on KOH microscopy. Timepoint: Patients were evaluated clinically on 7th and 14th day of treatment and 4 weeks after completion of treatment. Method of measurement: Clinical evaluation.</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>PNS SHIFA</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-27</approval_date>
        <contact_name>Ehical review committee, PNS Shifa</contact_name>
        <contact_address>PNS Shifa Hospital, DHA Phase 2, Karachi Karachi Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
