<?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>IRCT20190731044392N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-30</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Grape seed extract in treatment of fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>The effect of grape seed extract supplementation on glycemic status, lipid profile, plasma atherogenic index, liver enzymes, anthropometric indices and some inflammatory and antioxidant indices in overweight and obese patients with nonalcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61413</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a simple randomized clinical trial on subjects with fatty liver. In this study, individuals are divided into two groups of drugs and placebo. The method of assigning subjects to each group is that individuals are assigned every other one, Blinding description: First, researchers will explain the study to the participants. This study is a triple-blind study. The two groups, medications and placebo, receive completely similar capsules, and they do not know the contents of the capsule. The statistical analyzer is not informed about the groups. Also, the therapist will not know about the intervention groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Non Alcoholic Fatty liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Daily intake of 260 mg grape seed extract supplement (twice a day and two tablets equivalent to 2.5 g each time) for 60 days. Intervention 2: Control group: Recipient of two 1 g placebo tablets (containing cellulose, silicon dioxide and starch) per day for 2 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared after the participants in the study are unrecognizable.

When:
The data access period after printing the article.

To whom:
The data in this study will be available to researchers working at academic and scientific institute.

Conditions:
Any analysis can be done with the consent of the main researcher.

Where to obtain:
Hamidreza Razmi

How to obtain:
The researcher or pharmaceutical company can send their request to the email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Razmi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6165777696</zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>hamidrezarazmi95@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ahmad Zare Javid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6165777696</zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>ZareJavid-a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20-60 years old patient with non alcoholic fatty liver disease</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have diabetes, cardiovascular, kidney and other hepatic diseases
 Pregnant or lactating women
 Smoking
 Alcohol consumption
 Use of dietary supplements</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: Daily intake of 260 mg grape seed extract supplement (twice a day and two tablets equivalent to 2.5 g each time) for 60 days</i_keyword>
      <i_keyword>Control group: Recipient of two 1 g placebo tablets (containing cellulose, silicon dioxide and starch) per day for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Alanine aminotransferase. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Interlukine-6. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Total cholestrol. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Triglyciride. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Atherogenic index of plasma. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Hemoglobin A1c. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Digital scale.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Body weight in kilograms divided by height squared in meters.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before intervention and 2 months after intervention. Method of measurement: By measuring tape according to meter.</prim_outcome>
      <prim_outcome>Hip circumference. Timepoint: Before intervention and 2 months after intervention. Method of measurement: By measuring tape according to meter.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-14</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical sciences</contact_name>
        <contact_address>Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
