<?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>IRCT20230910059392N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-09</date_registration>
      <primary_sponsor>Semnan University</primary_sponsor>
      <public_title>The Effect of Ashwagandha Supplements on Football Players</public_title>
      <acronym></acronym>
      <scientific_title>Acute effects of Ashwagandha consumption on aerobic and anaerobic power and fatigue in soccer players</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72552</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Other, Other design features: The functional tests of this study are specific to soccer, Randomization description: Block randomization, blocks of 4, 6 and 8, block sequence randomly and the unit of randomization is the individual, which is done using the RAND function of Excel statistical software. The epidemiologist consultant will prepare a list of subjects based on random numbers created through Excel software (between 0 and 1) before starting the work. Subjects are entered into the random chain in order from number 1 to 30, Blinding description: In this study, the packaging of the placebo similar to the original drug is done by someone other than the researcher (as an informed person) and the drugs are assigned a code. The packages are delivered to the team coach along with a form where the names of the players are noted in the relevant codes. The coach is not aware of the contents of the packages. Medicines are distributed among the players randomly and the players (participants) are also unaware of the contents of the packages. At the end, the examiner performs the tests without knowing about the groupings and writes down the names in a form. The data collected from the pre-test and post-test forms are provided to the statistical analyst to analyze the data based on codes and names. Finally, after analyzing the data, decoding is done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ashuganda and football.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 15 people consume two 300 mg capsules of placebo (Corn starch) every day, in the morning and evening for14 days. Intervention 2: Intervention group: 15 people consume two 300 mg capsules of Ashwagandha (Olimp Ashwagandha 600 Sport) every day, (in the morning and evening) for14 days.</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:
Provide information on the main outcome

When:
Access starts 6 months after results are published

To whom:
Only researchers working in academic and scientific institutions

Conditions:
The use of data in review studies and meta-analysis is allowed

Where to obtain:
It is possible to receive the data via e-mail: h.akbari@semnan.ac.ir

How to obtain:
Submission of documents is one month after the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akbari Hakimeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911135131</zip>
        <telephone>+98 21 3153 2165</telephone>
        <email>h.akbari@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akbari Hakimeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911135131</zip>
        <telephone>+98 23 3153 2165</telephone>
        <email>h.akbari@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>General health and no physical and motor complications such as back pain and knee pain
Regular physical activity (bodybuilding exercises, soccer training at least three months prior to screening for this study) will be considered eligible</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>If taking dietary supplements, medications or steroids used to increase physical performance
A history of heart disease, diabetes, Digestive diseases, depression, stroke or neurological disorder
Participants if taking sedatives .misuse of drugs, orthopedic or surgical injury in the last 6 months</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 15 people consume two 300 mg capsules of placebo (Corn starch) every day, in the morning and evening for14 days.</i_keyword>
      <i_keyword>Intervention group: 15 people consume two 300 mg capsules of Ashwagandha (Olimp Ashwagandha 600 Sport) every day, (in the morning and evening) for14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aerobic power. Timepoint: Aerobic capacity will be measured before and 48 hours after Ashwagandha consumption. Method of measurement: Aerobic power is measured with a stopwatch to determine the desired record and distance, and the YOYO IRL1 test is used to evaluate aerobic power.</prim_outcome>
      <prim_outcome>Anaerobic power. Timepoint: Anaerobic capacity will be measured before and 48 hours after Ashwagandha consumption. Method of measurement: Anaerobic power is measured with a stopwatch to determine the desired record and distance. RAST test is used to measure anaerobic power.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Fatigue will be measured before and 48 hours after Ashwagandha consumption. Method of measurement: Fatigue is measured with a stopwatch to determine the desired record and distance, which the RAST test is used to evaluate fatigue.</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>Semnan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-28</approval_date>
        <contact_name>Ethics committee in Semnan medical science research</contact_name>
        <contact_address>Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
