<?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>IRCT20110726007117N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-17</date_registration>
      <primary_sponsor>National Institute for Medical Research Development(NIMAD)</primary_sponsor>
      <public_title>Effect of non-invasive devises on fat reduction</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Cryolipolysis, Ultrasound Cavitation and Radio Frequency on fat thickness as adipocity-Selective non_invasive fat reduction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type:permuted block randomization
Blocking is generally done in two ways that either the size of the groups is equal or the size of the groups is different and in this study the groups are equal. Random allocation software is used for randomization.
Sealed envelopes with a random sequence are used to hide the random allocation.
Based on the sample size of the study, some non-transparent envelopes were prepared (in order to avoid envelope content), and each of the random sequences was generated on a fixed-name card and a more transparent envelope card. For the purpose of random order retrieval, the outermost layer of the numbered packets is assigned the same order. 
Finally the lid envelope lid is placed in boxes, respectively. At the beginning of registration,
Based on the order of entry of the eligible participants into the study, one of the packages named in the open order and its assigned group of participants is revealed.
A person who do a randomization is different  with the person  who studying the participants in terms of entry and exit criteria and registered them to study, Blinding description: in this study data analyzer will be blind.</study_design>
      <phase>4</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group  will  receive combined cryolipolysis and ultrasound cavitation.  People who entered to the this group will go to 8 times under cryolipolysis and 4 times with a 2-week interval for Ultrasound cavitation.To evaluate the body composition,BIA model770 machine The construction of South Korea will be used. The Fusiomed Cryolipolysis device will be used with the BIO TEC brand in Italy, and will be usedultrasound cavitation  ESM-4500ME model craft maker Mega Son, a South Korean brand. Intervention 2: Control group: Cryolipolysis group. Entrants to this group will be have eight times a week for cryolipolysis.</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 "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Ghayour Mobarhan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Biochemistry &amp; Nutrition Research Center, Cardiovascular Research Centre, Avicenna (Bu-Ali) Research Institute, Mashhad University of Medical Sciences (MUMS), Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3882 8888</telephone>
        <email>ghayourm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Ghayour Mobarhan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Nutrition Department, school of Medicine, Mashhad University of Medical Science campus,Azady square,Mashhad,Khorasan Razavi.Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1394491388</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>ghayourm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>BMI more than 25
Age between 18 and 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Lactation
Active implant device such as pacemaker, defibrillator or drug delivery
Tooth infection
History of previous surgery in the desired area
History of  stroke or facial paralysis (Bell's palsy)
Botulinum toxin or injection of aesthetic drugs in the area (abdomen) during the last 6 months.
Treatment with dermal fillers, radioactive methods or laser</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group  will  receive combined cryolipolysis and ultrasound cavitation.  People who entered to the this group will go to 8 times under cryolipolysis and 4 times with a 2-week interval for Ultrasound cavitation.To evaluate the body composition,BIA model770 machine The construction of South Korea will be used. The Fusiomed Cryolipolysis device will be used with the BIO TEC brand in Italy, and will be usedultrasound cavitation  ESM-4500ME model craft maker Mega Son, a South Korean brand.</i_keyword>
      <i_keyword>Control group: Cryolipolysis group. Entrants to this group will be have eight times a week for cryolipolysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"َAnthropometric indices". Timepoint: "before and after of the intervention". Method of measurement: "bio impedance analyser(BIA)".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>"Examine the satisfaction of the body composition". Timepoint: before and after of the  intervention. Method of measurement: "body satisfaction questionnaire(BSQ)".</sec_outcome>
      <sec_outcome>"psychological distress scale evaluation". Timepoint: "before and after of the  intervention". Method of measurement: kessler psychological distress scale k10 score interpretation.</sec_outcome>
      <sec_outcome>"Lipid profile measurement". Timepoint: "before and after of the  intervention". Method of measurement: "blood sampling".</sec_outcome>
      <sec_outcome>"Liver enzyme measurement". Timepoint: "before and after of the  intervention". Method of measurement: "blood sampling".</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>National Institute for Medical Research Development(NIMAD)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-16</approval_date>
        <contact_name>"Ethics committee of National Institute of Medical Research Development" (NIMAD)</contact_name>
        <contact_address>No 21, Besat Alley, West Fatemi ST, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
