<?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>IRCT20210611051539N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-05</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of  Nano zataria multiflra antifungal supplement on patients with onychomycosis with saprophytic agent</public_title>
      <acronym></acronym>
      <scientific_title>evaluation of antifungal supplement properties of zataria multiflora - loaded nanostructural lipid carriers in the treatment of onychomycosis caused by filamentous fungi</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In that study, nano thyme gel and placebo were prepared in completely similar packaging and drug tubes, and in order to observe random allocation, www.randomizer.org was used in such a way that by using the codes received from the site, the drug and The isolated placebo is then placed inside a similar envelope and presented to the patient in a completely random manner. Therefore, the patient will not be informed about the nature of the drug and the type of group it belongs to. Since the smell created by Shirazi thyme essential oil can cause deviations in the study, therefore, both the drug and the placebo are mixed together in a closed tube and the doctor or expert randomly gives the drug to the patient. Gives, Blinding description: The patients participating in the study, as well as the researcher, including the master student who is responsible for their dissertation, as well as the physicians who perform the intervention, are among the people who are blinded in the study. The drug and placebo are both placed in similar envelopes. The fellow doctors and graduate students who are performing the intervention are not aware of its contents. Only the drug code and the patient code will be stated in the questionnaire. But the executor is aware of the code as an analyst and assigns it to control and intervention groups. Participants, on the other hand, are not aware of the contents of the envelope, but will be informed that their supplement may be a placebo.</study_design>
      <phase>2-3</phase>
      <hc_freetext>onychomycosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: For patients with onychomycosis caused by filamentous fungi, 1% nano thyme gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. Auxiliary medicine is taken along with the main medicine that is determined by a specialist doctor. Intervention 2: Control group: For patients with onychomycosis caused by filamentous fungi, a placebo gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. It is consumed by a specialist doctor.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I will share after the implementation and completion of the project and also after the publication of the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Maryam Moazeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shayan 3 bld, Ghaem12 st, Ghaem st, Talegani blvd , Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817845423</zip>
        <telephone>+98 11 5233 1197</telephone>
        <email>moazeni.maryam@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Moazeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Floor , Shayan 3 Building, Ghaem 12 Alley, Ghaem Street, Sari Town, Mazandaran, Iran</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817845423</zip>
        <telephone>+98 11 3325 7911</telephone>
        <email>moazeni.maryam@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All people over 18 years old with mild-moderate onychomycosis caused by filamentous fungi</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have taken antifungal drugs during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B35.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tinea unguium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: For patients with onychomycosis caused by filamentous fungi, 1% nano thyme gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. Auxiliary medicine is taken along with the main medicine that is determined by a specialist doctor.</i_keyword>
      <i_keyword>Control group: For patients with onychomycosis caused by filamentous fungi, a placebo gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. It is consumed by a specialist doctor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvment of fungal lesions in term of clinical and mycological criteria. Timepoint: before the intervention and 2,4 weeks after the treatment start. Method of measurement: Examining clinical symptoms such as inflammation, itching, scaling and examination in terms of direct smear and fungal culture in the interval of 2, 4 and 6 weeks.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine- Payambar azam university-18th Km of Farah Abad Road- Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
