<?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>IRCT20150706023084N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effects of liraglutide and radio frequency cavitaion on abdominal obesityof the effects of liraglutide and radio frequency cavitaion on abdominal obesity</public_title>
      <acronym>liraCav tial</acronym>
      <scientific_title>A Randomized Clinical Trial Comparing the Efficacy of Liraglutide and Radiofrequency Cavitation in the Management of Abdominal Obesity.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using Microsoft Excel software, random allocation of participants into study groups was performed. for this purpose, the random number generation function in Microsoft excel was used to assign a random decimal number between 0 and 1 to each participant. these random numbers were then sorted in ascending order, and based on their order, participants were allocated to the intervention and control groups.this randomization method was applied to minimize selection bias and to ensure homogeneity of baseline characteristics between the study groups, Blinding description: Due to the difference in the type of interventions (subcutaneous liraglutide injection versus radiofrequency cavitation therapy), complete blinding of participants and treating staff is not feasible. Therefore, the outcome assessor and data analyst will be blinded to the group allocation. The outcome evaluator (measuring weight, BMI, and waist circumference) and the statistical analyst will remain unaware of patient group assignments throughout the study. Accordingly, the trial is considered double-blind (evaluator- and analyst-blinded).</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consisted of 32 participants who underwent radiofrequency cavitation therapy over a period of 3 months. The treatment was performed at the Obesity and Physiotherapy Clinic of the Islamic Azad University of Medical Sciences and consisted of one 30-minute session per week applied to the abdominal region for the reduction of abdominal fat and central obesity.Radiofrequency cavitation is a noninvasive body contouring method that utilizes ultrasound waves and radiofrequency energy to reduce localized adipose tissue and improve skin tightness. At the end of the study, the investigated parameters measured at baseline and at the completion of the treatment period were compared. Intervention 2: Control group:  liraglutide The control group consisted of 32 participants who received daily subcutaneous injections of liraglutide for a period of 3 months. The dosing regimen was administered as follows: 0.6 mg daily during the first week, 1.2 mg daily during the second week, 1.8 mg daily during the third week, 2.4 mg daily during the fourth week, and 3 mg daily from the fifth week until the end of the study, administered via subcutaneous injection.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no additional information is avaiable.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ََAlireza Arefzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farhikhtegan hospital, opposite the Central Office of Islamic Azad University, end of  North Sattari Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477899679</zip>
        <telephone>+98 21 4486 7262</telephone>
        <email>Alireza.arefzadeh@iautmu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Arefzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farhikhtegan hospital, opposite the Central Office of Islamic Azad University, end of  North Sattari Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477899679</zip>
        <telephone>+98 21 4486 7262</telephone>
        <email>Alireza.arefzadeh@iautmu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All individuals without specific medical conditions, aged betweem 35 and 70 years
Obese and have a body mass index(BMI) higher than 27</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Drug abuse
Obesity due to specific endocrine disorders
Alcohol use
Specific diseases such as cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consisted of 32 participants who underwent radiofrequency cavitation therapy over a period of 3 months. The treatment was performed at the Obesity and Physiotherapy Clinic of the Islamic Azad University of Medical Sciences and consisted of one 30-minute session per week applied to the abdominal region for the reduction of abdominal fat and central obesity.Radiofrequency cavitation is a noninvasive body contouring method that utilizes ultrasound waves and radiofrequency energy to reduce localized adipose tissue and improve skin tightness. At the end of the study, the investigated parameters measured at baseline and at the completion of the treatment period were compared</i_keyword>
      <i_keyword>Control group:  liraglutide The control group consisted of 32 participants who received daily subcutaneous injections of liraglutide for a period of 3 months. The dosing regimen was administered as follows: 0.6 mg daily during the first week, 1.2 mg daily during the second week, 1.8 mg daily during the third week, 2.4 mg daily during the fourth week, and 3 mg daily from the fifth week until the end of the study, administered via subcutaneous injection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal measurement. Timepoint: Three months. Method of measurement: By measuring tape.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-22</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>Tehran faculty of medical sciences, Headquarters building of Islamic Azad university, Gholhak junction Amin Pabarja Street. Dr shariati st. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
