<?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>IRCT20171216037911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-03</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effects of  Cichorium fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effects of aqueous extract of Cichorium Intybus L on non-aloholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28280</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants in the study will randomly assign to two intervention and control groups. A randomized, stratified sampling method will use to control the confounding factors (age and gender) and the samples will first divide into two sex groups (male and female) and then will categorize again in each group based on age (less than 35 years and more than 35 years). Finally, the samples in each class will be randomly assigned to intervention or control groups, Blinding description: Each participant is randomly assigned a colored card (green for the case and blue for the control group). Participants are informed that they may be in either case and control group and finally, members of the control group will receive Chicory if they want it. Principle investigator does not know the meaning of colored cards.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nonalcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will receive powder of aqueous extracts of 15 g chicory (equivalent to 1 g of extract) prepared by Avigeh Tejarat Sepehr Co. as two 500 mg capsules daily, for 12 weeks. Intervention 2: Control group: The control group will receive daily 1 g of starch as placebo in the form of two 500 mg capsules similar to Chicory capsules for 12 weeks.</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 The decision will be made at the end of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Asar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Shahid Beheshti, Ave. Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976160</zip>
        <telephone>+98 28 3335 6696</telephone>
        <email>m.asar@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Bastani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat hospital, Minoodar Distric</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976160</zip>
        <telephone>+98 28 3335 6696</telephone>
        <email>a.bastani@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosis of NAFLD according to ultra-sonography
age between 18 to 65 years
increase SGPT leve more than 30mgr/dl</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other causes of liver disease, including viral hepatitis or autoimmune, high alcohol consumption (more than 210 g / week in men and more than 140 g / week in women), Wilson's disease, hereditary hemochematosus, alpha1-antitrypsin deficiency and cirrhosis
gestation and lactation;
diagnosis of cancers
consumption of hepatotoxic drugs or drugs using for management of NAFLD
diagnosis of cardiovascular diseases
diagnosis of diabetes mellitus
diagnosis of hypothyroidism</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of liver</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: They will receive powder of aqueous extracts of 15 g chicory (equivalent to 1 g of extract) prepared by Avigeh Tejarat Sepehr Co. as two 500 mg capsules daily, for 12 weeks.</i_keyword>
      <i_keyword>Control group: The control group will receive daily 1 g of starch as placebo in the form of two 500 mg capsules similar to Chicory capsules for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Grade of fatty liver. Timepoint: before &amp; 12 weeks after intervention. Method of measurement: liver and bile duct supersonic graphy.</prim_outcome>
      <prim_outcome>Aspartate aminotransferases. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Waist circumfrence. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: by using of meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum Alanine Aminotransferase. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Serum ALP. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Weight. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: Mechanical scale.</sec_outcome>
      <sec_outcome>Serum triglyceride. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Total cholestrol. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Serum HDL. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Serum LDL-C. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Fasting plasma glucose. Timepoint: before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention. Method of measurement: blood sample.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-29</approval_date>
        <contact_name>Ethics commitee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Blv, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
