<?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>IRCT20230225057528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-23</date_registration>
      <primary_sponsor>Imam Khomeini International University</primary_sponsor>
      <public_title>The Effect of Exercise and Turmeric on non alcoholic Fatty Liver Disease</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Six Weeks of Exercise Snacking and Turmeric Supplement on Hepatic Enzymes of People with Non-Alcoholic Fatty Liver Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: An 8-sided dice will be used for randomization. two numbers will be assigned to each groups and the dice will be rolled for each patient, and given the number on the dice, the participants will be in one of the four groups of Exercise Snacking, Turmeric Supplement, Exercise Snacking and Turmeric Supplement, and Control, Blinding description: Blood test analysis and sonogram will be sent to the the statistician via office clerk. The results will be entered to SPSS and they will be labeled as 1, 2, 3, 4 for three intervention groups and one control group (that only the clerk will know of) and they will be analyzed by the statistician. Therefore, the statistician is not aware of the allocation of the interventions to the participants.</study_design>
      <phase>3</phase>
      <hc_freetext>Non Alcoholic Fatty Liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises. Intervention 2: Intervention Group 2: Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks. Intervention 3: Intervention group 3: Turmeric Supplement and Exercise Snacking. Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises. Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks. Intervention 4: Control group: No intervention.</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 No further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Gudarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 80, 13th Shaqayeq Street</address>
        <city>Andhisheh Phase 1</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3354395917</zip>
        <telephone>+98 21 6552 4357</telephone>
        <email>s993172008@edu.ikiu.ac.ir</email>
        <affiliation>Imam Khomieni International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Gudarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 80, 13th Shaqayeq Street</address>
        <city>Andhisheh Phase 1</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3354395917</zip>
        <telephone>+98 21 6552 4357</telephone>
        <email>s993172008@edu.ikiu.ac.ir</email>
        <affiliation>Imam Khomieni International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with non alcoholic fatty liver disease who have not taken turmeric supplement or regular exercise in the last month.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises.</i_keyword>
      <i_keyword>Intervention Group 2: Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks</i_keyword>
      <i_keyword>Intervention group 3: Turmeric Supplement and Exercise Snacking. Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises. Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine transaminase. Timepoint: Prior to the intervention and one week after the intervention. Method of measurement: Blood test, Hitachi 912 Chemistry Analyzer.</prim_outcome>
      <prim_outcome>Aspartate transaminase. Timepoint: Prior to the intervention and one week after the intervention. Method of measurement: Blood test, Hitachi 912 Chemistry Analyzer.</prim_outcome>
      <prim_outcome>Alkaline phosphatase. Timepoint: Prior to the intervention and one week after the intervention. Method of measurement: Blood test, Hitachi 912 Chemistry Analyzer.</prim_outcome>
      <prim_outcome>Fatty liver grade. Timepoint: Prior to the intervention and one week after the intervention. Method of measurement: Ultrasound.</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>Imam Khomeini International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-22</approval_date>
        <contact_name>Research ethics committees of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Reseach and Technology Department, Maveddat Street, First Alley, Shahid Beheshti boulvard Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
