<?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>IRCT20180623040199N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-05</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through the "Blocked Randomization List" (random blocking with 6 blocks), in the same random order, patients will be divided into intervention and control groups, Blinding description: A dermatologist who checks patients at intervals is unaware of the wet cupping.
The analyzer is unaware of the patients whom wet cupping is done for them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acne.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the back area between the first to third thoracic vertebra, during the first visit and the sixth week, the cupping will be done. In addition, antibiotic antibiotic azithromycin will be given 3 times a week. Intervention 2: Control group:They will receive antibiotic azithromycin three times a week, as well as sham cupping.</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:
It is published through the supplementary file

When:
6 months

To whom:
Researchers and other people can access data if they need it

Conditions:
For using in systematic review articles, reprogramming and modeling can be used in other studies. In case of need,  should be emailed to the programmer or entered university site.

Where to obtain:
Executor of plan or University

How to obtain:
Email the scheduler,she answers.

Comments:
All information is available to others for the advancement of science.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Tabatabaeishourijeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of Iranian Medicine, pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kermaniriat St.,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7615687644</zip>
        <telephone>+98 34 3312 2912</telephone>
        <email>shahrzad.tab7@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh Tajadini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of Iranian Medicine, pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kermanh,Modiriat St.,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7615687644</zip>
        <telephone>+98 34 3312 2912</telephone>
        <email>Dr-haleh@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate and severe  acne on the face;
Informed consent to participate in the study;
No pregnancy;
Without any specific disease including chronic diseases, hormonal imbalance, anemia,  and other coagulation problems, and Aids and other infectious diseases.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy;
Occurrence of specific diseases during treatment;
Wet cupping in the past three months;
Taking roaccutane in the past year.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Xii Diseases of skin and subcutaneous tissues</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the back area between the first to third thoracic vertebra, during the first visit and the sixth week, the cupping will be done. In addition, antibiotic antibiotic azithromycin will be given 3 times a week.</i_keyword>
      <i_keyword>Control group:They will receive antibiotic azithromycin three times a week, as well as sham cupping.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acne. Timepoint: Initially, the sixth week and the twelfth week. Method of measurement: By using Modified Global Acne Grading Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Initially and the twelfth week. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The prevalent temperament of people with acne. Timepoint: Initially and the twelfth week. Method of measurement: Questionnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-24</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Thirteenth floor, block A, Central Headquarters of the Ministry of Health and Medical Education, simaye Iran Street between South Felamak and Zarafshan, Ghods Town (West), Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
