<?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>IRCT20231205060268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-20</date_registration>
      <primary_sponsor>The University of Qom</primary_sponsor>
      <public_title>Investigating the effect of two weeks of vitamin C and ginger supplements on hematological indicators and muscle damage</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of a high intense interval training session followed by two weeks of Vitamin C and ginger supplementation on some hematological indicators and muscle damage in young male athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: Investigating the simultaneous effect of Vitamin C and Ginger on the amount of muscle damage caused by intense sports activity; Using workout protocol "Tabata", Randomization description: Individual randomization method using the online software of https://randomizer.org, Blinding description: Subjects are entered into the test in a single-blind manner. In this research, the supplement and placebo groups were used in capsules of the same color and size, and considering that the subjects were not aware of the supplement and placebo, but the researcher was aware of the capsules. Therefore, one-sided research was used in this research. In the supplement and training group, vitamin C and ginger supplements were used with a dose of 1 gram in capsules, as well as 1 gram of corn starch in 1 gram capsules in the placebo group, similar to the supplementation groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Investigating the effect of two weeks of vitamin C and ginger supplements on hematological indicators and muscle damage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: the group that consumes vitamin C produced by Iran Daru Company. The dosage is 1000 mg per day, in two meals per day after meals. Duration of use 14 days. Intervention 2: Intervention group B: the group that consumes the ginger supplement produced by Gol Daru Company. The dosage is 1000 mg per day, in two meals per day after meals. Duration of use 14 days. Intervention 3: Intervention group C: the group that simultaneously consume vitamin C produced by Iran Daru Company and ginger supplement produced by Gol Daru Company. The dosage of each supplement is 1000 mg per day, in two servings per day after meals. Duration of use 14 days. Intervention 4: Control group: The placebo group consumes 1000 mg of corn starch per day, in two meals and after meals. Duration of use 14 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Confidentiality of subjects' information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Afrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 142, Baghiyatallh St., Yazdanshahr</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716773956</zip>
        <telephone>+98 25 3288 4090</telephone>
        <email>m_a1618@yahoo.com</email>
        <affiliation>The University of Qom</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blv. Alghadir, Univesity of Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716146611</zip>
        <telephone>+98 25 3210 3699</telephone>
        <email>a.ghasemi@qom.ac.ir</email>
        <affiliation>University of Qom</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The gender of all subjects is male.
Boys aged 15 to 19 in Taekwondo who have been practicing sports continuously for more than two years.
All subjects practiced at least three sessions a week before entering the study.
None of the subjects used nutritional and energy supplements.
By making the call, the elite athletes, after knowing all the stages of research and testing, declare their agreement by completing the consent form.
In the consent form for athletes under legal age, their legal guardian/guardian must also declare their consent and consent.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Creating sports injuries in athletes before entering the research.
The existence of the effects of the athlete's previous injury, which may harm his health by conducting research.
The subject has joint or cardiovascular problems.
The subject has certain 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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: the group that consumes vitamin C produced by Iran Daru Company. The dosage is 1000 mg per day, in two meals per day after meals. Duration of use 14 days.</i_keyword>
      <i_keyword>Intervention group B: the group that consumes the ginger supplement produced by Gol Daru Company. The dosage is 1000 mg per day, in two meals per day after meals. Duration of use 14 days.</i_keyword>
      <i_keyword>Intervention group C: the group that simultaneously consume vitamin C produced by Iran Daru Company and ginger supplement produced by Gol Daru Company. The dosage of each supplement is 1000 mg per day, in two servings per day after meals. Duration of use 14 days.</i_keyword>
      <i_keyword>Control group: The placebo group consumes 1000 mg of corn starch per day, in two meals and after meals. Duration of use 14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect of vitamin C and ginger on lactate dehydrogenase enzyme in athletes. Timepoint: A: On the first day after performing the training protocols, a 5cc blood sample is taken from the basilic vein of the arm. B: After fourteen days of taking the supplement, blood sampling is done on the fourteenth day and after repeating the training protocols. Method of measurement: After blood sampling, the amount of lactate dehydrogenase enzyme is measured in the laboratory using the LDH-P kit according to the optimal standard method of the German Biochemical Society (OPT.DGKC).</prim_outcome>
      <prim_outcome>Effect of vitamin C and ginger on Creatine kinase enzyme of athletes. Timepoint: A: On the first day after performing the training protocols, a 5cc blood sample is taken from the basilic vein of the arm. B: After fourteen days of taking the supplement, blood sampling is done on the fourteenth day and after repeating the training protocols. Method of measurement: After blood sampling, the amount of creatine enzyme is measured in the laboratory using the CK-NAC kit using the optimal standard method of the German Biochemical Society (OPT.DGKC).</prim_outcome>
      <prim_outcome>The effect of vitamin C and ginger on the hematology of athletes. Timepoint: A: On the first day after performing the training protocols, a 5cc blood sample is taken from the basilic vein of the arm. B: After fourteen days of taking the supplement, blood sampling is done on the fourteenth day and after repeating the training protocols. Method of measurement: After blood sampling, complete blood cell count (CBC) is done in the laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increasing anaerobic power. Timepoint: A: The first day of performing training protocols based on the anaerobic test. B: After fourteen days of taking the supplement, on the fourteenth day, exercise protocols are performed based on the Rest Anaerobic Test. Method of measurement: Based on the subject's weight and the time recorded each time over a distance of 35 meters.</sec_outcome>
      <sec_outcome>Improved fatigue index. Timepoint: A: The first day of performing training protocols based on the anaerobic test. B: After fourteen days of taking the supplement, on the fourteenth day, exercise protocols are performed based on the Rest Anaerobic Test. Method of measurement: The difference between the peak power and the minimum power, divided by the minimum power, multiplied by a percentage.</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 Qom</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-11</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences</contact_name>
        <contact_address>No 83, Aly 4, 1 St. , Safashahr Ave. Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
