<?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>IRCT2014090210826N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-26</date_registration>
      <primary_sponsor>Research deputy, Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Purslane seeds in patients with  nonalcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Purslane seeds on liver enzymes, lipid profile and FBS in patients with  nonalcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11246</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: computerized genererated random number table.</study_design>
      <phase>3</phase>
      <hc_freetext>Non alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: using low caloric diet (kilo caloric/ body weight) - 500.15% protein, 55% carbohydrate, 30% fat.also they use10 gr purslane seed daily for 8 weeks. Intervention 2: Control group: using low caloric diet (kilo caloric/ body weight) - 500. 15% protein, 55% carbohydrate, 30% fat.</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 decision will be made Depending on the case and the request of other researchers</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Azade Najarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd University of Medical Sciences. Shohadaye Gomnam, Alalam squer, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353820910014</telephone>
        <email>azadnajarzadeh@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Azade Najarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd University of Medical Sciences. Shohadaye Gomnam, Alalam squer, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353820910014</telephone>
        <email>azadnajarzadeh@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 25 to75 years old
body mass index&gt;=25
distinction of the grade of fatty liver by sonography and understanding by doctor
not pregnant or lactating
do not have any other diseases like gastrointestinal, liver, renal or thyroid disease and diabetes
individuals who are not under special diet and do not participate in another intervention
do not use low caloric diet or drugs for decrease weight in 3 months
do not use vitamin supplements 2 months ago
do not change in drugs for reduce lipid and hypertension during the intervention
Exclusion criteria: patients who are not  using more than 30 percent of determined Purslane seeds sachet will excluded from study.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.O</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic fatty liver disease (NAFLD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: using low caloric diet (kilo caloric/ body weight) - 500.15% protein, 55% carbohydrate, 30% fat.also they use10 gr purslane seed daily for 8 weeks.</i_keyword>
      <i_keyword>Control group: using low caloric diet (kilo caloric/ body weight) - 500. 15% protein, 55% carbohydrate, 30% fat.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver supersonic graphy. Timepoint: before &amp; after intervention. Method of measurement: radiologic picture.</prim_outcome>
      <prim_outcome>AST. Timepoint: before and after intervention. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>ALT. Timepoint: before and after intervention. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Alkalin phosphat. Timepoint: before and after intervention. Method of measurement: blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: before avd after intervention. Method of measurement: digital scale.</sec_outcome>
      <sec_outcome>Hieght. Timepoint: before avd after intervention. Method of measurement: stadiometer,m.</sec_outcome>
      <sec_outcome>Waist circumfrence. Timepoint: before avd after intervention. Method of measurement: meter,cm.</sec_outcome>
      <sec_outcome>FBS. Timepoint: before and after intervention. Method of measurement: mg/dl.</sec_outcome>
      <sec_outcome>Total cholestrol. Timepoint: before and after intervention. Method of measurement: mgr/dl, blood sample.</sec_outcome>
      <sec_outcome>LDL. Timepoint: before and after intervention. Method of measurement: mgr/dl, blood sample.</sec_outcome>
      <sec_outcome>HDL. Timepoint: before and after intervention. Method of measurement: mgr/dl, blood sample.</sec_outcome>
      <sec_outcome>Triglycerid. Timepoint: before and after intervention. Method of measurement: mgr/dl, blood sample.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: before and after intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Malon di aldehid. Timepoint: before and after intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>DPPH. Timepoint: before and after intervention. Method of measurement: blood sample.</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>Research deputy, Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-01</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Science</contact_name>
        <contact_address>Imam Hosein Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
