<?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>IRCT20200921048783N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-22</date_registration>
      <primary_sponsor>Abadan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Grape seed extract in treatment of fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of Grapex on serum biochemical factors in Non-alcoholic Fatty Liver Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57601</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double 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 double-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.</study_design>
      <phase>2</phase>
      <hc_freetext>Fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment and receiving Grapex capsule  (Grape seed extract) 200 mg daily for 2 mounths. Intervention 2: Control group: Receiving placebo capsule daily for 2 mounts.</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:
Hoda Mojiri-Forushani

How to obtain:
The researcher or pharmaceutical company can send their request to the academic 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>Hoda Mojiri-Forushani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan University of Medical Sciences, Beginning of 30 meter Ave, Zolfaghari Street, Abadan city</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6319811154</zip>
        <telephone>+98 61 5338 4004</telephone>
        <email>dr.mojiri@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoda Mojiri-Forushani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan University of Medical Science, Beginning of  the 30 meter Ave, Zolfaghari Street, Abadan city</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6319811154</zip>
        <telephone>+98 61 5338 4004</telephone>
        <email>dr.mojiri@yahoo.com</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with fatty liver
BMI equal to 30-40</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwilling to enter the study
Sensitivity to Grapex capsules</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: Treatment and receiving Grapex capsule  (Grape seed extract) 200 mg daily for 2 mounths.</i_keyword>
      <i_keyword>Control group: Receiving placebo capsule daily for 2 mounts.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aspart amino transferase. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Alanin amino transferase. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Antioxidant total capacity. Timepoint: Beginning of the study and 2 months after treatment. Method of measurement: Blood sample.</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>Abadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-23</approval_date>
        <contact_name>Ethical committee of Abadan University of Medical Sciences</contact_name>
        <contact_address>Zolphaghari Ave, Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
