<?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>IRCT20220523054967N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-03</date_registration>
      <primary_sponsor>The University of Razi</primary_sponsor>
      <public_title>The effects of ginseng on sports and cognitive performance in hypoxia conditions after taking acetazolamide</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of a period of Ginseng Consumption on Exercise and Cognitive Performance in Sports Science Female Students during Hypoxia Condition after taking Acetazolamide</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: Someone other than researchers will use random allocation software with block randomization method to group subjects. During the grouping process, each subject will be assigned a unique identification code, which will be provided to the main researchers along with the intended intervention (ginseng or placebo). The unique identification code is used as a label to identify the group of each subject after the end of the research. The random allocation software can perform block randomization. The sample size and the names of the two groups (ginseng and placebo) are defined in the main randomization menu. Then, the block design with equal blocks is entered. Also, the formatting of the unique identification code is defined with a specific number of digits. The final step is to create a random list in which the unique identification code and group name will be specified for each number, Blinding description: Because the study was double-blind, the subjects and the researchers did not know who would take ginseng or a placebo, and someone else would check the results. Also, in order not to distinguish the drug and the placebo, they will be prepared in the same capsules and the placebo group will use maltodextrin.</study_design>
      <phase>3</phase>
      <hc_freetext>hypoxia.</hc_freetext>
      <i_freetext>Intervention 1: Complementary group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take ginseng for two weeks and on the last day (the day before the test) they take acetazolamide and on the day of the test they take the last dose of ginseng and acetazolamide. In other words, they consume ginseng for a period of two weeks. A one-week grace period will be considered. Intervention 2: Placebo group: apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take a placebo for two weeks, and on the last day (the day before the test), they take acetazolamide, and on the day of the test, they take the last dose of placebo and acetazolamide. In other words, they take a placebo for a period of two weeks. A one-week grace period will be considered.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>The University of Razi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students in the field of physical education (third semester of bachelor's degree and above)
Place of residence and education in Kermanshah city
Age range of 18 to 29 years
Body mass index between 18.5 and 24.9
Having general health to participate in sports activities with the doctor's approval
Regular aerobic exercise program in the 6 months before the beginning of the research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>29 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from any chronic disease
History of cognitive disorders or neurological diseases
Being pregnant
Excessive bleeding during menstruation
History of allergies and sensitivities
Consumption of any sports supplement in two months before the beginning of the research
Smoking and alcohol consumption
Blood donation in 2 months before the beginning of the research
History of staying at altitudes of more than 2000 meters in the two months before the beginning of the research</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Complementary group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take ginseng for two weeks and on the last day (the day before the test) they take acetazolamide and on the day of the test they take the last dose of ginseng and acetazolamide. In other words, they consume ginseng for a period of two weeks. A one-week grace period will be considered.</i_keyword>
      <i_keyword>Placebo group: apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the reaction time test in normal conditions and simulated altitude conditions and the aerobic fitness test in simulated altitude conditions. They take a placebo for two weeks, and on the last day (the day before the test), they take acetazolamide, and on the day of the test, they take the last dose of placebo and acetazolamide. In other words, they take a placebo for a period of two weeks. A one-week grace period will be considered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endurance sports performance. Timepoint: After taking ginseng or placebo and after applying hypoxia. Method of measurement: Astrand test for women is used to measure the maximum power of the subjects.</prim_outcome>
      <prim_outcome>Simple visual reaction time. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia. Method of measurement: Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA).</prim_outcome>
      <prim_outcome>Simple auditory reaction time. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia. Method of measurement: Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA).</prim_outcome>
      <prim_outcome>Selective visual reaction time. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia. Method of measurement: Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA).</prim_outcome>
      <prim_outcome>Combined reaction time. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginseng or placebo and before and after applying hypoxia. Method of measurement: Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA).</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>The University of Razi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-27</approval_date>
        <contact_name>Ethics Committee of Razi University of Kermanshah</contact_name>
        <contact_address>Taq Bostan, University Street Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
