<?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>IRCT2016040927296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-03</date_registration>
      <primary_sponsor>School of Traditional Medicine,Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Dietary Management Based on Iranian Traditional Medicine on  patients with Non- Alcoholic Fatty Liver Disease</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Effect of Dietary Management Based on Iranian Traditional Medicine on Insulin Resistance in patients with Non- Alcoholic Fatty Liver Disease: A controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22391</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: The case group will receive the dietary recommendations based on Iranian traditional medicine designed for fatty liver. This includes elimination of food items that are harmful to liver and addition of items that are beneficial for liver. Each patient will complete the food diary questionnaire   everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from study. Intervention 2: The control group will receive modern nutrition dietary recommendations. Each patient will complete the food diary questionnaire everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from the study.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Gorji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>z.gorji@sbmu.ac.ir   z.gorji@gmail.com</email>
        <affiliation>School of Traditional Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasool Choopani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>rchoopani@sbmu.ac.ir</email>
        <affiliation>School of Traditional Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: patient between 18 and 60years old; non alcoholic fatty liver (based on positive sonography and rule out of alcohol use; viral hepatitis; hemochromatosis; Wilson disease and autoimmune disease); no cirrhosis; patient with insulin resistance.&#13;
Exclusion criteria: the reluctance of patients to continue to cooperate; insulin injection; food allergies; liver obstructive diseases and patient hospitalization.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k70-k77</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of liver</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The case group will receive the dietary recommendations based on Iranian traditional medicine designed for fatty liver. This includes elimination of food items that are harmful to liver and addition of items that are beneficial for liver. Each patient will complete the food diary questionnaire   everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from study.</i_keyword>
      <i_keyword>The control group will receive modern nutrition dietary recommendations. Each patient will complete the food diary questionnaire everyday which will be evaluated every month.Those patients that have followed less than 70% of the recommendations will be excluded from the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before intervention and 3 months after intervention. Method of measurement: HOMA-IR formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before intervention and months1,2 and after intervention. Method of measurement: Scale and Meter.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before intervention and months1,2 and after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Alanine Aminotransferase. Timepoint: Before intervention and at the end of intervention. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>Aaspartat Aminotransferase. Timepoint: Before intervention and at the end of intervention. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before intervention and at the end of intervention. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: At the beginning of intervention and at the end of intervention. Method of measurement: Questionnaire (SF-36).</sec_outcome>
      <sec_outcome>HgbA1C. Timepoint: Before intervention and at the end of intervention. Method of measurement: TINIA.</sec_outcome>
      <sec_outcome>Serum Insulin. Timepoint: At the beginning of intervention and at the end of intervention. Method of measurement: ECL.</sec_outcome>
      <sec_outcome>Serum Albumin. Timepoint: At the beginning of intervention and at the end of intervention. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>Ferritin. Timepoint: At the beginning of intervention and at the end of intervention. Method of measurement: ELISA.</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>School of Traditional Medicine,Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-06</approval_date>
        <contact_name>Medical Ethics Committee, Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway university of Medical Sciences. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
