<?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>IRCT20180526039848N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of cutaneous leishmaniasis with thymol loaded chitosan gel</public_title>
      <acronym>cutaneous leishmaniasis</acronym>
      <scientific_title>Evaluation of the treatment of cutaneous leishmaniasis with thymol loaded chitosan gel, as topical supplemental therapy (A RCT study)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Those who evaluate the outcome are different from those who give the drug to the patient (the doctor gives the medicine) and the consequences will only be written by the code on a separate sheet (the consequences by the code introduced by the student).
The statistician does not know any of the groups and does not know the type of treatment and will only do statistical work with specific codes.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cutaneous leishmaniasis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Includes ten people with 2% chitosan gel in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime. Intervention 2: Intervention Group 2: Includes ten people with 5% chitosan gel in one of the wounds plus Glucantime to increase the effect compared to the other wound of the patient who is treated only with Glucantime. Intervention 3: Intervention Group 3: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 5% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done. Intervention 4: Intervention Group 4: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 10% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done. Intervention 5: Intervention Group 5: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 15% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done.</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:
All images of patients' wounds during treatment

When:
Up to two years after the completion of the project

To whom:
Project collaborators

Conditions:
Have a face-to-face conversation with project executives about your idea

Where to obtain:
Have a written request or in person with the project executors

How to obtain:
A written request should be given to the executors of the  project

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bibi Razieh Hosseini Farash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Parasitology and Mycology, Faculty of Medicine, Mashhad University</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2454</telephone>
        <email>HoseiniFR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bibi Razieh Hosseini Farash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square. Medical faculty</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2454</telephone>
        <email>HoseiniFR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>There are at least two lesions, in one case intervention + glucantime and in the other lesion only glucantime is prescribed.
15 to 60 years
Skin lesions at least one centimeter in size
Leishmaniasis confirmed by a parasitologist
consent signature</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who do not use the drug according to the plan
People who do not go to the clinic on the scheduled days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B55.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cutaneous leishmaniasis</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>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Includes ten people with 2% chitosan gel in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.</i_keyword>
      <i_keyword>Intervention Group 2: Includes ten people with 5% chitosan gel in one of the wounds plus Glucantime to increase the effect compared to the other wound of the patient who is treated only with Glucantime.</i_keyword>
      <i_keyword>Intervention Group 3: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 5% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done</i_keyword>
      <i_keyword>Intervention Group 4: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 10% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done</i_keyword>
      <i_keyword>Intervention Group 5: Includes ten individuals with the appropriate percentage of chitosan gel from the two primary intervention groups in combination with 15% thymol in one of the wounds locally plus glucantime to increase the effective effect compared to the patient's other wound only It is treated with glucantime, it is done</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the lesion diameter (millimeters) using image processing software. Timepoint: From the first week of treatment and patient visit the clinic for the first time (once every three days to 45 days). Method of measurement: processing software.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-05</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Azadi aquare Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
