<?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>IRCT20161023030445N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-26</date_registration>
      <primary_sponsor>Vice Chancellor for research of Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Propolis on Non-alcoholic fatty liver disease</public_title>
      <acronym>NAFLD</acronym>
      <scientific_title>Effect of Propolis on liver functional indexes in patients with Non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: using block randomization method with a block size of 4. The list of randomization was computer-generated and a person, who was not aware of the nature of the trial, packed the supplements and placebo capsules in numbered bottles based on the list. The other person who was not aware of random sequences allocated the patients to the numbered bottles, Blinding description: All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Nonalcoholic fatty liver disease (NAFLD).</hc_freetext>
      <i_freetext>Intervention 1: Control group: placebo containing starch, oral capsule, 500 mg, twice a day for three months with standard treatment. Intervention 2: Intervention group: Propolis, oral capsule, 500 mg, twice a day for three months with standard treatment.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Vahid Yousefinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hospital Research Department,Tohid Hospital, Geriashan Ave  Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616812131</zip>
        <telephone>+98 87 3324 7855</telephone>
        <email>hooman56y@yahoo.com</email>
        <affiliation>Liver &amp; Digestive Research Center,Kurdistan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vahid Yousefinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hospital Research Department,Tohid Hospital, Geriashan Ave, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616812131</zip>
        <telephone>+98 87 3324 7855</telephone>
        <email>hooman56y@yahoo.com</email>
        <affiliation>Liver &amp; Digestive Research center,Kurdistan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>subjects over 20 years old
subjects diagnosed with NAFLD by increased levels of ALT and AST
Confirmation of NAFLD in Sonography report</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>viral hepatitis or autoimmune
diabetes
women who were pregnant or lactating
Use of effective drugs on liver tests in the last 2 months (Statins, Glitazones , Chlorpromazine , Vit E, OCP , Anabolic Steroids, Thionamides , etc.)
Hemochromatosis
Cirrhosis
Alcohol consumption of more than 140cc in men and 70 cc in women per week
Infectious diseases
herbal allergies
history of allergic reactions to bee products.</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>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: placebo containing starch, oral capsule, 500 mg, twice a day for three months with standard treatment</i_keyword>
      <i_keyword>Intervention group: Propolis, oral capsule, 500 mg, twice a day for three months with standard treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine Aminotransferase (ALT). Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Aspartate Aminotransferase (AST). Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Grade of fatty liver. Timepoint: in the beginning and end of Intervention. Method of measurement: Sonography.</prim_outcome>
      <prim_outcome>Alkaline Phosphatase (ALP). Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Body Mass Index (BMI). Timepoint: in the beginning and end of Intervention. Method of measurement: kg/m2 by measuring height and weight and use of scale.</prim_outcome>
      <prim_outcome>Gamma glutamyl transpeptidase. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Bilirubin. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Cholestrol. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>High Density Lipoprotein (HDL). Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
      <prim_outcome>Low Density Lipoprotein (LDL). Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting Blood Serum. Timepoint: in the beginning and end of Intervention. Method of measurement: mg/dl by using specific serum kit.</sec_outcome>
      <sec_outcome>TNFα. Timepoint: in the beginning and end of Intervention. Method of measurement: Pg/ml by using specific serum kit.</sec_outcome>
      <sec_outcome>Interleukin 6. Timepoint: in the beginning and end of Intervention. Method of measurement: Pg/ml by using specific serum kit.</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 of Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-31</approval_date>
        <contact_name>Ethics committee of Kurdistan university of medical sciences</contact_name>
        <contact_address>Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
