<?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>IRCT20230805059042N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effect of Supplementation of Garlic and Ginger on Delayed Onset Muscle Soreness and Muscular Damage</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Short-Term Supplementation of Garlic and Ginger on Delayed Onset Muscle Soreness and Muscular Damage Induced by a Progressive Resistance Training Session in Inactive Middle-Aged Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determining the age and pairing of the participants, they will be grouped by a simple random method. In this way, 3 number envelopes including envelope number 1, envelope number 2 and envelope number 3 will be considered for 3 groups of ginger supplement, garlic supplement and starch supplement. And the lottery will be done by someone other than the researcher, Blinding description: In the present study, the participants were blinded. The purpose and reason of the research will be explained to the participants in the briefing session and then the informed consent form will be taken from the participants. The participants will not be informed in which of the consumption groups of garlic, ginger or starch supplements.The intervention in the three groups is completely similar in terms of shape, color, smell, and the way of taking the supplements as well as the training sessions.</study_design>
      <phase>3</phase>
      <hc_freetext>Delayed contusion and muscle damage.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: the ginger supplement group that consumes 2 capsules of 500 mg of Gol Daru ginger manufacturing plant daily in 2 meals with 250 ml of water. Intervention 2: The second intervention group: the garlic supplement group that consumes 2 capsules of 500 mg of garlic produced by Gol Daru pharmaceutical factory in 2 meals with 250 ml of water daily. Intervention 3: The third intervention group: the placebo group that consumes 2 capsules of 500 mg of starch produced by Gol Daru pharmaceutical factory in 2 meals with 250 ml of water daily.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Hodaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Ferdowsi Blvd, Elahia Town, First Entry, Number 17</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4681769778</zip>
        <telephone>+98 11 5423 7182</telephone>
        <email>mahya.hodaei@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Hodaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Ferdowsi Blvd, Elahia Town, First Entry, Number 17</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4681769778</zip>
        <telephone>+98 11 5423 7182</telephone>
        <email>mahya.hodaei@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy inactive middle-aged women with an age range of 35 to 55 years
Having a BMI in the range of 26 to 30</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from various diseases or musculoskeletal injuries
Suffering from specific and underlying diseases (Diabetes, Cardiovascular diseases, Endocrine diseases, Blood pressure disorders (Hypertension or Hypotension), etc.)
Smoking or alcohol consumption
Use of anti-inflammatory, steroid and non-steroidal drugs for at least 2 months before
Use of any antioxidant supplements in the 6 months prior to the start of the study
Any sensitivity or allergy to research supplements
History of regular physical activity or sports in the six months before the start 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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: the ginger supplement group that consumes 2 capsules of 500 mg of Gol Daru ginger manufacturing plant daily in 2 meals with 250 ml of water.</i_keyword>
      <i_keyword>The second intervention group: the garlic supplement group that consumes 2 capsules of 500 mg of garlic produced by Gol Daru pharmaceutical factory in 2 meals with 250 ml of water daily.</i_keyword>
      <i_keyword>The third intervention group: the placebo group that consumes 2 capsules of 500 mg of starch produced by Gol Daru pharmaceutical factory in 2 meals with 250 ml of water daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lactate dehydrogenase level. Timepoint: Before the intervention and 14 days after the intervention (at each turn, immediately after training). Method of measurement: Blood sampling from the pre-elbow vein after the training session.</prim_outcome>
      <prim_outcome>Creatine kinase level. Timepoint: Before the intervention and 14 days after the intervention (at each turn, immediately after training). Method of measurement: Blood sampling from the pre-elbow vein after the training session.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Circumference around the thigh. Timepoint: Before the intervention and 14 days after the intervention(At any time, immediately and 24 hours after training). Method of measurement: Tape measure.</sec_outcome>
      <sec_outcome>Knee joint range of motion. Timepoint: Before the intervention and 14 days after the intervention(At any time, immediately and 24 hours after training). Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Perception of muscle pain. Timepoint: Before the intervention and 14 days after the intervention(At any time, immediately and 24 hours after training). Method of measurement: Visual Analog Scale Questionnaire.</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, Tonekabon branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Tunkabon branch</contact_name>
        <contact_address>Kilometer 3 Chalus-Wali Abad road, Tankabon Islamic Azad University complex Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
