<?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>IRCT20200804048307N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Quercetin supplementation on inflammatory and Creatinine kinase responses after a swimming session in girls</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Quercetin supplementation on the response of C-reactive protein,Interleukin 6 and Creatine kinase after a boring swimming session in teenage girls.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50940</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: The medical team is expected to be present at the pool site during the swim test, Blinding description: Starch powder and Quercetin supplement are placed inside the capsules of the same shape. Participants and researchers are not aware of the type of capsule received. As a result, the study is performed in a double-blind manner.</study_design>
      <phase>3</phase>
      <hc_freetext>Girls Swimmers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Includes ten swimmers who take Quercetin supplements in the form of 500 mg capsules for two days, morning and night. During this period, they continue their normal life.(Solgar Quercetin , made in the USA). Intervention 2: Control group: includes ten swimmers who take placebo capsules for 14 days in the form of capsules containing starch in the morning and night. During this period, they continue their normal life. (Daro Gostar placebo capsules, made in Iran).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data after unidentifiable individuals

When:
3 months after the publication of the article

To whom:
Participants in the study can be informed of the results and documentation in detail to know how the intervention works so that they can use the protocols if they are useful. Researchers can also access documents to use the results in similar research.

Conditions:
The use of data for citation with reference to the source is unrestricted.

Where to obtain:
Send Ensie Ahmadpour an email
ncahmadpour47@gmail.com

How to obtain:
Applicants will send an e-mail with the subject of the request to the address mentioned. As soon as they receive the e-mail, a form will be sent to them that the details of the people and the reason for their request will be recorded in this form. The documents will be provided to people as a PDF file.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ensieh Ahmadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, No. 14, Farvardin Alley, Delbkhah Crossroads, Pasdaran Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477865687</zip>
        <telephone>+98 21 2257 7532</telephone>
        <email>ncahmadpour47@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada Hesarak Boulevard, University Square, at the end of Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 9827</telephone>
        <email>m.gholami@srbiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Female gender
Age range 14 to 16 years old
Do not use antioxidant supplements and anti-inflammatory drugs in the last 6 months
At least 3 years of swimming experience</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>16 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to sign informed consent
Injury
Smoking and alcohol
History of cardiovascular and respiratory diseases</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>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Includes ten swimmers who take Quercetin supplements in the form of 500 mg capsules for two days, morning and night. During this period, they continue their normal life.(Solgar Quercetin , made in the USA).</i_keyword>
      <i_keyword>Control group: includes ten swimmers who take placebo capsules for 14 days in the form of capsules containing starch in the morning and night. During this period, they continue their normal life. (Daro Gostar placebo capsules, made in Iran)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Creatine Kinase. Timepoint: Before taking the supplement,14 days after taking the supplement ,after a boring swim. Method of measurement: Pars Azmon Laboratory Kits No. 90004 Using Autoanalyzer (USA).</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: Before taking the supplement,14 days after taking the supplement ,after a boring swim. Method of measurement: Biosystem kits, made in Spain.</prim_outcome>
      <prim_outcome>Interleukin 6. Timepoint: Before taking the supplement,14 days after taking the supplement ,after a boring swim. Method of measurement: Eliza kit made by the French company Diaclone.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximum oxygen consumption(VO2max). Timepoint: Before performing boring swimming. Method of measurement: Cooper test (2400 meters in 12 minutes) and using the formula.</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, Faculty of Literature, Tehran University of Research Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-28</approval_date>
        <contact_name>Research Ethics Committee of the Institute of Physical Education and Sports Science</contact_name>
        <contact_address>No. 3, Fifth Alley, Mir Emad St., Ostad Motahhari St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
