<?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>IRCT2015122425686N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of the Capparis pickle on Fatty Liver</public_title>
      <acronym></acronym>
      <scientific_title>The investigation of the effects of Capparis Spinosa Fruit pickle (Traditional Iranian Medicine product) on Liver Transaminases in Nonalcoholic Fatty Liver Disease (NFLD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21439</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1 : the intervention group  In addition to teaching life style and training package similar at baseline and follow up with phone calls weekly, daily intake of 40 mg pickled capers fruit with meals for lunch and dinner. Intervention 2: Intervention 2: teaching life style and training package similar at baseline and follow up with phone calls weekly in the control group.</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>Narjes.Khavasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building, Tabriz University of Medical Sciences, University Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665931</zip>
        <telephone>+98 41 3337 9528</telephone>
        <email>narjes.khavasi@yahoo.com; nxavasi@gmail.com</email>
        <affiliation>Tabriz University of Medical and Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Hosein Somi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665931</zip>
        <telephone>+98 41 3337 9528</telephone>
        <email>mhosseinsina@yahoo.com</email>
        <affiliation>Tabriz University of Medical and Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: nonalcoholic fatty liver (elevated SGPTand sonography results); age 12 to 80 years. Exclusion criteria: Hyperlipidemia during treatment or Severe hyperlipidemia; pregnancy and lactation; Coagulopathies; thyroid disease; cirrhosis, viral hepatitis; Overt diabetes; Drugs that affect metabolism or liver enzyme levels such as OCP, Corticosteroid, ..; patients who are hospitalized in the course of treatment and therefore could not continue the treatment; patients who cannot eat pickled capers fruit for various reasons; Patients who cannot adhere to the guidelines recommended in the lifestyle training.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic fatty liver disease (NAFLD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1 : the intervention group  In addition to teaching life style and training package similar at baseline and follow up with phone calls weekly, daily intake of 40 mg pickled capers fruit with meals for lunch and dinner</i_keyword>
      <i_keyword>Intervention 2: teaching life style and training package similar at baseline and follow up with phone calls weekly in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>SGPT. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>SGOT. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total chlo. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>FBS. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>TG. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>VLDL. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>LDL. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>HDL. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Fasting Insulin. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Cs-CRP. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>BMI. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: Digital weighing scales and measuring the height of meters.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: VAS Questionnaire.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Before the intervention, the end of the twelfth week intervention. Method of measurement: HOMA Index.</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 for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-26</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz,Iran Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
