<?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>IRCT20200215046506N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-27</date_registration>
      <primary_sponsor>Vice Chancellor for research, Islamic Azad University Gachsaran Branch</primary_sponsor>
      <public_title>The effect of eight weeks of aerobic training with silymarin consumption on glycemic indices and liver enzymes in men with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of aerobic training with silymarin consumption on glycemic indices and liver enzymes in men with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45799</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to randomly assign the samples to four groups, Excel software is used as follows:
First, a list of participants is compiled and we assign each participant a specific number using the RAW function, then randomly select each participant using the RANDBETWEEN and VLOOKUP functions and assign them to each participant. We assign 4 groups to groups. The first, second, third and fourth subjects were assigned to the control group, aerobic exercise group, silymarin supplementation group, and aerobic training + silymarin group, respectively. Others are assigned to groups in the same way.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Three sessions of exercise per week and each session 20-45 minutes with intensity of 60 to 85% of heart rate reserve, for eight weeks. Intervention 2: Intervention group: Use silymarin for 8 weeks daily in two coats of 140 mg silicarin coated tablets (one after breakfast and one after dinner) with the Lever Flower brand manufactured by Gul Daroo Company (economic code IRC12280250372). Intervention 3: Intervention group: Three sessions of exercise per week, each session of 20-45 minutes, with 60-85% heart rate reserve plus silymarin for 8 weeks daily, two 140 mg silicarin-coated tablets (one after breakfast and one with breakfast). After Dinner) By Liver Flower brand made by Gol Daroo Company (economic code IRC12280250372). Intervention 4: Control group: Take a coated tablet containing wheat flour.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Khajehlandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581797836</zip>
        <telephone>+98 74 3233 5910</telephone>
        <email>a.khajehlandi@yahoo.com</email>
        <affiliation>Islamic Azad University Gachsaran  Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Khajehlandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581797836</zip>
        <telephone>+98 74 3233 5910</telephone>
        <email>a.khajehlandi@yahoo.com</email>
        <affiliation>Islamic Azad University Gachsaran Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic patients who have had a minimum of 3 years of diabetes
Age of participants 40 - 50 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The lack having the effects of diabetes, like diabetic foot ulcers
The lack history of heart disease and lung disease
The lack regular exercise of athletic activity in the last two years
The lack of tobacco in the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Three sessions of exercise per week and each session 20-45 minutes with intensity of 60 to 85% of heart rate reserve, for eight weeks</i_keyword>
      <i_keyword>Intervention group: Use silymarin for 8 weeks daily in two coats of 140 mg silicarin coated tablets (one after breakfast and one after dinner) with the Lever Flower brand manufactured by Gul Daroo Company (economic code IRC12280250372).</i_keyword>
      <i_keyword>Intervention group: Three sessions of exercise per week, each session of 20-45 minutes, with 60-85% heart rate reserve plus silymarin for 8 weeks daily, two 140 mg silicarin-coated tablets (one after breakfast and one with breakfast). After Dinner) By Liver Flower brand made by Gol Daroo Company (economic code IRC12280250372)</i_keyword>
      <i_keyword>Control group: Take a coated tablet containing wheat flour</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glucose. Timepoint: Two months after intervention. Method of measurement: Blood serum.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight Lose. Timepoint: Two months after training. Method of measurement: by Scale.</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>Vice Chancellor for research, Islamic Azad University Gachsaran Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Ethics committee of  Islamic Azad University ,Gachsaran Branch</contact_name>
        <contact_address>Daneshjo Blvd.,Gachsaran Gachsaran Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
