<?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>IRCT20140107016123N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-04</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pomegranate extract on non alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pomegranate extract tablet on some of metabolic factor, hepatokines (fetuin A, FGF21), inflammatory biomarkers, anthropometric indices and grade of  fatty liver  in patients with non-alcoholic fatty Liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a simple randomized clinical trial on subjects with nonalcholic fatty liver. In this study, individuals are divided into two groups of drugs and placebo.Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block, Blinding description: To make this study double-blinded and keep the researchers and participants unaware of the taken tablets, before the intervention, the container of pomegranate extract and placebo were coded as A or B by a third person (non-researcher).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver disease (NAFLD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pomegranate extract tablet 225 mg twice daily for 12 weeks. Intervention 2: Control group: Placebo twice daily 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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Jafarirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3336 7543</telephone>
        <email>sjafarirad@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Jafarirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3336 7543</telephone>
        <email>sjafarirad@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age:18 to 65 years old
Body mass index 29.4 to 40
Presence of non-alcoholic steathepatitis in ultrasonography with degree of steatosis higher than grade 1
consent with collaboration in study
Not taking any dietary supplements
Not being on a special diet
the liver enzyme serum level (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST))  1.5 times greater than the highest normal up to a 5 times more than the highest level of normal range
non diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with a history of hepatitis including A, B and C; Other liver diseases including autoimmune liver disease, liver transplantation, liver metabolic disease, Wilson's disease
gastrointestinal diseases
cardiovascular diseases
anemia
kidney diseases
endocrine disorders (such as hypothyroidism or hyperthyroidism, Cushing's)
having a history of drinking more than 10 grams per day in women and more than 20 grams per day in men
smoking
Taking any medicine, insulin, hepatic steatosis drugs
getting intravenous nutrition
getting special diets and taking vitamin supplements in the last three months
pregnancy or lactating
menopause
weight loss surgery during the last year
Unwillingness to cooperate</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pomegranate extract tablet 225 mg twice daily for 12 weeks</i_keyword>
      <i_keyword>Control group: Placebo twice daily for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine aminotransferase. Timepoint: before intervention and after 12 weeks. Method of measurement: seum level.</prim_outcome>
      <prim_outcome>Aspartate transaminase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Gamma glutamyl transferase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Alkaline phosphatase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Triglycerides. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Low density lipoprotein (LDL). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>High density lipoprotein (HDL). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Fasting insulin. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: before intervention and after 12 weeks. Method of measurement: 405÷(insulin×glucose)=HOMA-IR ; Homeostatic model assessment.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Fetuin A. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Fibroblast growth factor 21(FGF 21). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>High sensitive C reactive protein (hs-CRP). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Interlukin-6(IL-6). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.</prim_outcome>
      <prim_outcome>Weight. Timepoint: before intervention and after 12 weeks. Method of measurement: scale.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: before intervention and after 12 weeks. Method of measurement: waist circumference in CM.</prim_outcome>
      <prim_outcome>Body mass index (BMI). Timepoint: before intervention and after 12 weeks. Method of measurement: Ratio of weight (kg) to second power (in meters).</prim_outcome>
      <prim_outcome>Degree of hepatic steatosis. Timepoint: before intervention and after 12 weeks. Method of measurement: sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: before intervention and after 12 weeks. Method of measurement: Blood pressure monitor.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: before intervention and after 12 weeks. Method of measurement: Blood pressure monitor.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-12</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
