<?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>IRCT20180419039359N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-30</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract in patients with non-alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract on liver function, tumor necrosis factor α, malondealdehyde and adiponectin in patients with non-alcoholic fatty liver.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30707</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using Random allocation software. Also, randomization is stratified by age gender, Blinding description: The products ((cornus mas L.) fruit extract and placebo) are packed in the bottles that are same in terms of color, shape and size and labeled with "A" and "B" by an outside person who dose not know the details of the study. Therefore, participants and researchers will not be aware of the nature of the products in bottles.</study_design>
      <phase>3</phase>
      <hc_freetext>non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Daily intake of total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) for 12 weeks. Intervention 2: Control group: Daily intake of placebo for 12 weeks.</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 I have not decided yet. Publishing plan of it is still unclear.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Sadat Sangsefidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353820910014</telephone>
        <email>sangsefidi.zsadat@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Mozaffari-Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353820910014</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ALT levels more than 30 U / L in men and more than 19 U / L in women
Age 25-26 years
Diagnosis of the disease by ultrasonography and by a gastroenterologist
The patients with grade 1, 2 and 3 fatty liver
The consent of subject to participate in the study
The patients are from Yazd</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The history of diseases including cirrhosis, viral hepatitis, cardiovascular disease, diabetes, Wilson and cancer.
Consumption of medications including corticosteroids, nonsteroidal anti-inflammatory drugs, hypoglycemic agents or any medicine that affect blood glucose, tamoxifen, sodium valproate, methotrexate, probiotics, any medicine or supplement that affect  liver function, supplements with antioxidant and anti-inflammatory properties (such as vitamin D, vitamin E, omega-3, resveratrol) during 1 month before the study
Following a  special diet during 1 month before the study
Pregnancy and breastfeeding
شlcohol consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Daily intake of total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) for 12 weeks.</i_keyword>
      <i_keyword>Control group: Daily intake of placebo for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of Alanine Aminotransferase (ALT). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</prim_outcome>
      <prim_outcome>Serum levels of Aspartate Aminotransaminase (AST). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</prim_outcome>
      <prim_outcome>Serum levels of Tumor necrosis factor α (TNF-α). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.</prim_outcome>
      <prim_outcome>Serum levels of Malondealdehyde (MDA). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.</prim_outcome>
      <prim_outcome>Serum levels of adiponectin. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.</prim_outcome>
      <prim_outcome>Serum levels of cytokeratin-18 fragment M30 (CK-18 M30). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.</prim_outcome>
      <prim_outcome>Liver steatosis. Timepoint: Before and after the 12-week intervention. Method of measurement: By ultrasonography.</prim_outcome>
      <prim_outcome>Liver fibrosis. Timepoint: Before and after the 12-week intervention. Method of measurement: By fibroscan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood glucose (FBS). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of Triglyceride (TG). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of High-density lipoprotein (HDL). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of Low-density lipoprotein (LDL). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of total cholesterol. Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of insulin. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Before and after the 12-week intervention. Method of measurement: By HOMA-IR and QUICKI.</sec_outcome>
      <sec_outcome>Lipid accumulation product. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Atherogenic index of plasma. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Atherogenic coefficient. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Castelli 1 index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Castelli 2 index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>TyG index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Fatty liver index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Hepatic steatosis index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Visceral adiposity index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>NAFLD-liver fat score. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Estimated glucose infusion rate. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Gamma glutamyl transpeptidase. Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.</sec_outcome>
      <sec_outcome>Serum levels of E-selectin. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA method.</sec_outcome>
      <sec_outcome>Serum levels of Asymmetric dimethylarginine. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA method.</sec_outcome>
      <sec_outcome>Serum levels of nitric oxide. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA method.</sec_outcome>
      <sec_outcome>Seum levels of C reactive protein. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA method.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-17</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences ,Alam Square. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-03</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences ,Alam Square. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
