<?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>IRCT20170609034406N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-26</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of allopurinol in preventing liver fibrosis in non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of allopurinol in preventing liver fibrosis in non-alcoholic fatty liver disease: A Randomized Placebo-Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>154</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Online randomization and permuted block randomization will be done, and in this way, random sequences with specific codes will be created, Blinding description: Due to the double-blind nature of this study, a person who has no role in the intervention and checking the entry and exit criteria will perform the randomization online and assign the patients to the groups based on the random sequence created. Another person, who has no role in the intervention and is unaware of the allocation of patients, will package the drugs based on the codes. This randomization and assignment of codes remains hidden from the researchers and participants until the statistical analysis is completed.</study_design>
      <phase>3</phase>
      <hc_freetext>Liver fibrosis in non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (Allopurinol + standard non-alcoholic fatty liver treatment): 77 patients will be included in the study based on inclusion and exclusion criteria and will receive 300 mg allopurinol once a day for 12 weeks along with standard treatments. Intervention 2: Control group: (receive placebo + standard non-alcoholic fatty liver treatment): 77 patients will be included in the study based on the entry and exit criteria and will receive a placebo equal to 300 mg of allopurinol once a day for 12 weeks along with standard treatments.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2 central building, Tabriz University of Medical Science, Golgasht Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>0098413372250</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Gharekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2 central building, Tabriz University of Medical Science, Golgasht Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3337 2250</telephone>
        <email>gharekhania@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-70 years
No history of alcohol consumption
Absence of other liver diseases
No previous allergy to allopurinol
In the case of diabetic patients, HbA1c (glycosylated hemoglobin) is less than 7% and the dose of antidiabetic medication has been stable for at least the last 3 months until the time of study entry.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and breastfeeding
Serum creatinine more than 1.5 mg/dl
Simultaneous use of drugs that interact with allopurinol
Simultaneous use of drugs that cause hepatic steatosis
Simultaneous use of research drugs effective on non-alcoholic fatty liver disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K74</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fibrosis and cirrhosis of liver</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: (Allopurinol + standard non-alcoholic fatty liver treatment): 77 patients will be included in the study based on inclusion and exclusion criteria and will receive 300 mg allopurinol once a day for 12 weeks along with standard treatments.</i_keyword>
      <i_keyword>Control group: (receive placebo + standard non-alcoholic fatty liver treatment): 77 patients will be included in the study based on the entry and exit criteria and will receive a placebo equal to 300 mg of allopurinol once a day for 12 weeks along with standard treatments.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum hs-CRP (C-Reactive Protein High-Sensitivity) level. Timepoint: At the beginning and end of the study. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>MDA (Malondialdehyde) level in serum. Timepoint: At the beginning and end of the study. Method of measurement: (MDA) Lipid Peroxidation Kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity (TAC) level in serum. Timepoint: At the beginning and end of the study. Method of measurement: Total Antioxidant Capacity Kit.</prim_outcome>
      <prim_outcome>FIB-4 non-invasive score. Timepoint: At the beginning and end of the study. Method of measurement: FIB-4: (Age [yr] x AST) / ((PLT [10(9)/L]) x (〖ALT〗^(1/2))).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-17</approval_date>
        <contact_name>Research Ethics Committees of Faculty of Pharmacy - Tabriz University of Medical Science</contact_name>
        <contact_address>Research Ethics Committees , 4th floor, Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaburi, Golgasht St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
