<?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>IRCT20201204049599N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-26</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Black garlic consumption on treatment of non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of black garlic on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66022</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used for randomization is Stratified Randomization. In this method, to eliminate the heterogeneity in age, gender and severity of steatosis variables, before applying random allocation, the samples will be classified based on these variables and then they will be randomly allocated into intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in addition to the usual treatment, will be recommended to consume 6 grams of black garlic in total per day before morning and evening meal for three months. Intervention 2: Control group: In addition to the usual fatty liver treatment, the control group was advised to follow FAO (Food and Agriculture Organization) recommendations by the researcher 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>Mohammad Reza Pashaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>+98 44 3346 9931</telephone>
        <email>pashaee.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Pashaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>+98 44 3346 9931</telephone>
        <email>pashaee.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>Age older than 18 years old from both sexes
BMI more than 30
Patients with non-alcoholic fatty liver disease diagnosed through ultrasound and referred to Imam Hospital Gastroenterology Clinic</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Special diets
Pregnancy and lactation during the study
Viral hepatitis
Alcohol consumption or history of alcohol consumption
Non-compliance to our recommendations regarding Black garlic consumption
Untreated hypothyroidism
Renal diseases
Taking drugs that increase liver enzymes
Alpha antitrypsin deficiency
Gastrointestinal disease such as celiac disease
Menopause
Diabetes mellitus
Herbal therapy
Heart failure and bone disease</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, in addition to the usual treatment, will be recommended to consume 6 grams of black garlic in total per day before morning and evening meal for three months.</i_keyword>
      <i_keyword>Control group: In addition to the usual fatty liver treatment, the control group was advised to follow FAO (Food and Agriculture Organization) recommendations by the researcher for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: At weeks 0, 12. Method of measurement: Scale, kg.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At weeks 0, 12. Method of measurement: Weight(kg)/[height(m)]2 , kg/m2.</prim_outcome>
      <prim_outcome>Gamma Glutamyl transferase. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method , IU/ Lit.</prim_outcome>
      <prim_outcome>Alkalin Phosphatase. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method , IU/ Lit.</prim_outcome>
      <prim_outcome>Aspartat transaminase. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, IU/Lit.</prim_outcome>
      <prim_outcome>Alanine Aminotransferase. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, IU/ Lit.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At weeks 0, 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>Waist circumference. Timepoint: At weeks 0, 12. Method of measurement: 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, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>LDL cholesterol. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: At weeks 0, 12. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Height. Timepoint: Before intervention. Method of measurement: Stadiometer, mm.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-30</approval_date>
        <contact_name>Research Ethics Committee of Urmia University of Medical Sciences - Imam Khomeini University Hospita</contact_name>
        <contact_address>Imam Khomeini Hospital; Ershad Blvd., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
