<?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>IRCT2016081629398N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-18</date_registration>
      <primary_sponsor>Vice Chancellor of Research, Kashan University Medical of Sciences</primary_sponsor>
      <public_title>The effect of Acoustic Wave Therapy on weight and abdominal fat in obese people</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Acoustic Wave Therapy added to nutritional diet and nutritional diet alone on weight and abdominal fat among women with Body Mass Index (BMI) greater than 30 Kilogram per square meter squared: a clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Non-probability sampling; Accidental or Convenience sampling. We will accept the participants by convenient sampling from the population of people who have been referred to the clinic. The participants need to satisfy the including criteria.</study_design>
      <phase>2</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Will take weight loss diet (1200-1500 Kcal with 55% carbohydrate, 20% protein and 20% fat)+one hour aerobics exercise+"Acoustic Wave Therapy" for abdominal site, 4000 pulses, frequency of 16 Hz, energy of 1.4 to 2.6 bar by D-ACTOR 200(STORZ MEDICAL AG, Switzerland)  for 10 sessions, twice a week. Intervention 2: Case group: Will take weight loss diet (1200-1500 Kcal with 55% carbohydrate, 20% protein and 20% fat)+one hour aerobic exercise, without using "Acoustic Wave Therapy".</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shokouh Sarbolouki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 53, Amirkabir Street</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8719695866</zip>
        <telephone>+98 31 5531 1099</telephone>
        <email>sarbolouki@kaums.ac.ir; shokoohs@yahoo.com</email>
        <affiliation>Kashan University Medical of Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shokouh Sarbolouki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 53, Amirkabir Street</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8719695866</zip>
        <telephone>+98 31 5531 1099</telephone>
        <email>sarbolouki@kaums.ac.ir; shokoohs@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Female; age range 35-45 years; Body Mass Index (BMI)&gt;30 kilogram per square meter; diagnosed with the cellulite grade II is skin criteria of abdomen region.&#13;
Exclusion criteria:&#13;
Diabetes; hypertension; cardiovascular disease; liver disease; blood clotting disorders; hypothyroidism; varicose veins; skin disease; cancer; favism; asthma; using some blood- thinning medications like: warfarin; heparin; aspirin; omega-3 fatty acids.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Will take weight loss diet (1200-1500 Kcal with 55% carbohydrate, 20% protein and 20% fat)+one hour aerobics exercise+"Acoustic Wave Therapy" for abdominal site, 4000 pulses, frequency of 16 Hz, energy of 1.4 to 2.6 bar by D-ACTOR 200(STORZ MEDICAL AG, Switzerland)  for 10 sessions, twice a week</i_keyword>
      <i_keyword>Case group: Will take weight loss diet (1200-1500 Kcal with 55% carbohydrate, 20% protein and 20% fat)+one hour aerobic exercise, without using "Acoustic Wave Therapy".</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before and 1.5 months after intervention. Method of measurement: kilogram, with scale.</prim_outcome>
      <prim_outcome>Body Mass Index (BMI). Timepoint: Before and 1.5 months after intervention. Method of measurement: kilogram/square meter(Kg/m2), calculated  by using weight/hight2 formula.</prim_outcome>
      <prim_outcome>Whole body fat. Timepoint: Before and 1.5 months after intervention. Method of measurement: kilogram, with body composition analyzer.</prim_outcome>
      <prim_outcome>Abdominal fat. Timepoint: Before and 1.5 months after intervention. Method of measurement: kilogram, with body composition analyzer.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before and 1.5 months after intervention. Method of measurement: centimeter, by strip meter.</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>Vice Chancellor of Research, Kashan University Medical of Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-05</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Kashan University Medical of Sciences, 5th kilometer of Qotb –e Ravandi Blvd. Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
