<?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>IRCT20151012024490N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-01</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Sambucus Ebulus leaf extract ointment in treatment results of Cutaneous Leishmaniasis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of Sambucus Ebulus leaf extract ointment and placebo, in treatment results of Cutaneous Leishmaniasis; A double blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27905</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into 2 groups; cases and controls based on Simple Random Allocation (random numbers table), Blinding description: All cases and controls will get an ointment which looked like in shape, color and smell. And each patient will get an unique code.</study_design>
      <phase>3</phase>
      <hc_freetext>Cutaneous Leishmaniasis.</hc_freetext>
      <i_freetext>Intervention 1: Sambucus Ebulus leaf extract ointment. In order to prepare the ointment, a 5% extract of the plant leaves in vaseline (and liquid paraffin) will be used. This drug will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time. Intervention 2: Placebo ointment contains the base compound (Vaseline and liquid paraffin) that will be similar to the drug in shape and smell and only the active ingredient will be absent. This placebo will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Safoora Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health Center, Sarabi street</address>
        <city>Gonbad kavoos</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6721611784771</zip>
        <telephone>+98 17 3328 6852</telephone>
        <email>dr.mozafari@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Omid Mozafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of medicine, Golestan University of Medical Sciences, Shast kola, Gorgan, Iran</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 17 3322 5124</telephone>
        <email>dr.mozafari@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with confirmed cutaneous leishmaniasis diagnosis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant women
patients with allergy to antimuan
passing more than three months from the first existence of skin lesions
getting any treatment for leishmaniasis in recent month 
patients whose wounds are on the eyelids, ear, nose or near the end of the lips and eyes (less than one centimeter)</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Sambucus Ebulus leaf extract ointment. In order to prepare the ointment, a 5% extract of the plant leaves in vaseline (and liquid paraffin) will be used. This drug will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time.</i_keyword>
      <i_keyword>Placebo ointment contains the base compound (Vaseline and liquid paraffin) that will be similar to the drug in shape and smell and only the active ingredient will be absent. This placebo will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Longest diameter of ulceration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.</prim_outcome>
      <prim_outcome>Longest diameter of Induration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.</prim_outcome>
      <prim_outcome>Healing rate. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: observation &amp; calculation.</prim_outcome>
      <prim_outcome>Treatment result. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation &amp; calculation.</prim_outcome>
      <prim_outcome>Healing rate. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation &amp; calculation.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-28</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Phalsaphy complex, Shast kola Road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
