<?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>IRCT20170825035890N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of “peganum harmala” in  treatment of pediculus capitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effectiveness of herbal product of “peganum harmala” and Permethrin1%in treatment of pediculus capitis patient in referrals to health center of Karaj city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30565</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done stratified randomization.</study_design>
      <phase>2</phase>
      <hc_freetext>Head lice.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group, two vials each containing 20cc oil esfand is given to be used according to the order. The consumption of oil is such that at the start of treatment 3 days (once a day) and every time the hair and scalp are smeared with oil and rinse after 20 minutes and one week later, the treatment is repeated in the same way.. Both groups emphasize that the drug should be used on dry and clean hair. In both groups, other family members are treated according to the first course of treatment case of family members, the likelihood of reinfection in both groups' decreases. Also, other health care needed to accelerate the treatment process (Including washing, sunbathing, and combing) both groups are trained and stressed to be done. Effect of treatment on the first, second and third days of the onset of the initial dose and one day after the end of the second stage, the treatment was performed with a face examination. Intervention 2: Control group: The other group is given the permethrin shampoo which is used once a day at the start of treatment and once a week later.</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:
Original outcome data

When:
Since 2020

To whom:
For researchers working in academic and scientific institutions and industry professionals

Conditions:
No special circumstances

Where to obtain:
Email address

How to obtain:
Receive email, study by researcher within two weeks, answering

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Maarefvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Street - Behesht Street - Faculty of Traditional Medicine</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>maarefvand@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Maarefvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Street - Behesht Street - Faculty of Traditional Medicine</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>maarefvand@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of head lice by an expert or doctor at a health center and approved by a researcher
Satisfaction of the patient or his parents from entering the plan
No drug or treatment for head lice treatment over the past 4 weeks</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant lady
People with skin lesions on the scalp
Children under two years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B85.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pediculosis due to Pediculus humanus capitis</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>In intervention group, two vials each containing 20cc oil esfand is given to be used according to the order. The consumption of oil is such that at the start of treatment 3 days (once a day) and every time the hair and scalp are smeared with oil and rinse after 20 minutes and one week later, the treatment is repeated in the same way.. Both groups emphasize that the drug should be used on dry and clean hair. In both groups, other family members are treated according to the first course of treatment case of family members, the likelihood of reinfection in both groups' decreases. Also, other health care needed to accelerate the treatment process (Including washing, sunbathing, and combing) both groups are trained and stressed to be done. Effect of treatment on the first, second and third days of the onset of the initial dose and one day after the end of the second stage, the treatment was performed with a face examination.</i_keyword>
      <i_keyword>Control group: The other group is given the permethrin shampoo which is used once a day at the start of treatment and once a week later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mature nest, lice egg. Timepoint: The first, second, third and eighth day of the onset of treatment. Method of measurement: Mature insect count and lice egg.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-18</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hafez Street -  Behesht Street - Faculty of Traditional Medicine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
