<?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>IRCT20171210037809N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of TABATA and  Piperine and Capsaicin on Nitric Oxide and Creatine Kinase</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Piperine and Capsaicin on Nitric Oxide and Creatine Kinase after 8 weeks Tabata bodybuilding execrcise</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40421</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Names of male volunteer athletes of stadiums of Gharchak city who interested to cooperation was recorded(200-250)/then they will complete the questionnaire of entry standard/ 30 persons will be selected/ then they will be numbered and their names will be written on sheets and will be spilled in a bowl.One  sheet will be selected in tern and the names will be  in one of the groups(3 groups of 10 people).</study_design>
      <phase>3</phase>
      <hc_freetext>In this study, the effect of Tabata's training and consumption  Capsaicin with Tabata's training and consumption of Peperin   Will be compared..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Capsaicin is a food supplement that contains 500 mg capsules,that  is used by America's Food NOW  , Cayenne brand.That  ,with a glass of water is taken, three times a day after eating, for 8 weeks. Intervention 2: Intervention group2 : Peprin Herbal and Edible Peppergin Capsules in Numeric Packages will be ,made in  pharmaceutical company Kimia Farawar Booali Iran.Each capsule contains will be 2.55 mg Piperine and 1.38 mg Gingerols.The formulation of this product  are from the extracts of Black Pepper, Long Pepper and Ginger.After a meal, a capsule ،twice and every time is taken . Intervention 3: Control group : No supplement /only Tabata  exercise.</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>Shahrzad sadat Abas-Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>IAU square. Naghshe- Jahan shahrak .Pishva . Varamin</address>
        <city>Varamin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33817-74895</zip>
        <telephone>+98 21 3672 5013</telephone>
        <email>dastavard96@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sharzad Abas-Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>IAU square. Naghshe- Jahan shahrak .Pishva . Varamin</address>
        <city>Varamin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1637876791</zip>
        <telephone>+98 21 3672 5014</telephone>
        <email>dastavard96@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lack of complementary supplementation use during the past six months
Having physical fitness preparation required
No history of any cardiovascular disease
Having the necessary age requirement( 20-25 years)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Cigarette  smoking
Using particular medication (insulin,  aminophylline, fursomide ....)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Capsaicin is a food supplement that contains 500 mg capsules,that  is used by America's Food NOW  , Cayenne brand.That  ,with a glass of water is taken, three times a day after eating, for 8 weeks.</i_keyword>
      <i_keyword>Intervention group2 : Peprin Herbal and Edible Peppergin Capsules in Numeric Packages will be ,made in  pharmaceutical company Kimia Farawar Booali Iran.Each capsule contains will be 2.55 mg Piperine and 1.38 mg Gingerols.The formulation of this product  are from the extracts of Black Pepper, Long Pepper and Ginger.After a meal, a capsule ،twice and every time is taken .</i_keyword>
      <i_keyword>Control group : No supplement /only Tabata  exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in Kreatine Kinase / Nitric Oxide enzymes. Timepoint: At the beginning of the study, after the start of the supplement and 8-week training period. Method of measurement: Use of special kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Changes in Creatine Kinase. Timepoint: The beginning of the study (before the intervention) and 8 weeks after completion of the supplementation and practice. Method of measurement: Kit  :unit/ on international unit.</sec_outcome>
      <sec_outcome>Nitric Oxide. Timepoint: The beginning of the study (before the intervention) and 8 weeks after. Method of measurement: Nitric Oxide assay kit.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-06</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medical Sciences, Islamic Azad University of Varamin Branch</contact_name>
        <contact_address>Naghshe-Jahan Bulvar/University of Square/ IAU Varamin- Pishva -Branch/ Pishva/ Varamin/ IRAN IAU Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
