<?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>IRCT20170206032417N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-28</date_registration>
      <primary_sponsor>Vice Chancellor for research of Urmia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of garlic powder in treatment of non alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>The effect of garlic powder supplementation on body composition, liver echogenicity, insulin resistance, liver enzymes, lipid profile and oxidative stress in patients with non alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34737</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-Alcoholic Fatty liver patients referred to the gastroenterology clinic of Imam Khomeini Hospital of Urmia were selected consecutively on the basis of inclusion and exclusion criteria from the date of 23 September until 22 December in year of 2018. The subjects that selected, randomly (using 45 cards 1 and 45 numbered 2 cards to the number of patients present in the study and randomly selecting the cards by the patients) divided into two groups of intervention (1) and control (2).
for double blinding, at the start of the study,in order to avoid any knowledge of the type of tablet taken by each group, the total number of packets containing garlic and placebo tablets by a person other than the researcher is encode in the form 1 and 2 and then are Available to the researcher, Blinding description: patient and investigator.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be consume 4 tablets of 400 miligrams per day garlic in addition to usual treatment for three months. Intervention 2: Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715799313</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5315799313</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with non alcoholic fatty liver disease
age of between 18 and 75</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>alcohol use
viral hepatitis
hepatocellular carcinoma
other causes of chronic liver disease
diabetes mellitus
untreated hypothyroidism
psychiatric disorder
kidney disease
pregnancy
lactation
allergy to garlic
patients with low blood pressure</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: The intervention group will be consume 4 tablets of 400 miligrams per day garlic in addition to usual treatment for three months.</i_keyword>
      <i_keyword>Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: At weeks 0, 6, 12. Method of measurement: scale. kg.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At weeks 0, 6, 12. Method of measurement: Weight(kg)\[height(m)]2 , kg\m2.</prim_outcome>
      <prim_outcome>Gamma Glutamyl transferase. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method , IU\ Lit.</prim_outcome>
      <prim_outcome>ALP. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method , IU\ Lit.</prim_outcome>
      <prim_outcome>Aspartat transaminase. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, IU\ Lit.</prim_outcome>
      <prim_outcome>Alanine Aminotransferase. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, IU\ Lit.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, IU\ Lit.</prim_outcome>
      <prim_outcome>Serum insulin. Timepoint: At weeks 0, 12. Method of measurement: Radioimmunoassay.</prim_outcome>
      <prim_outcome>Body fat mass. Timepoint: At weeks 0, 6, 12. Method of measurement: BIA, kg.</prim_outcome>
      <prim_outcome>Skeletal muscle mass. Timepoint: At weeks 0, 6, 12. Method of measurement: BIA, kg.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: At weeks 0, 6, 12. Method of measurement: BIA, cm.</prim_outcome>
      <prim_outcome>Hepatic steatosis. Timepoint: Before intervention and three month after intervention. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>HDL cholesterol. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>LDL cholesterol. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: At weeks 0, 6, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: At weeks 0, 12. Method of measurement: spectrophotometry, Nmol/l.</prim_outcome>
      <prim_outcome>SOD. Timepoint: At weeks 0, 12. Method of measurement: spectrophotometry, Nmol/l.</prim_outcome>
      <prim_outcome>MDA. Timepoint: At weeks 0, 12. Method of measurement: spectrophotometry, Nmol/l.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: At weeks 0, 6, 12. Method of measurement: Mercury sphygmomanometer, mmHg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: At weeks 0, 6, 12. Method of measurement: Mercury sphygmomanometer, mmHg.</prim_outcome>
      <prim_outcome>FATTY LIVER INDEX. Timepoint: At weeks 0, 6, 12. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Quantity of appetite. Timepoint: At weeks 0, 6, 12. Method of measurement: VAS questionnaire.</prim_outcome>
      <prim_outcome>Intestinal function. Timepoint: At weeks 0, 6, 12. Method of measurement: Bristol stool questionaire.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: At weeks 0, 12. Method of measurement: Formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-05</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences,orjans valley, Resalat boulevard Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
