<?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>IRCT20230805059037N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of short-term supplement of garlic and ginger on the respons of C-reactive protein to a progressive exercise session</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of short-term supplement of garlic and ginger on the respons of C-reactive protein to a progressive exercise session in overweight 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/71830</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: A semi-experimental applied study with a pre-test, post-test research design with a control group, Randomization description: Simple random method with the entry criteria of BMI of the participants who must be in the overweight range of 26 to 30. After determining the BMI of the people from a certain BMI to below, a simple random draw of 3 people, 3 
people, and 3 envelopes number 1 Number 2 and number 3 are separated for 3 ginger supplement groups - garlic supplement group - placebo group. The lottery is done by someone other than the researcher, Blinding description: In the present study, the participants were kept blind. In this way, the purpose and reason for conducting the research will be explained to the participants in the briefing session, an informed consent form will be obtained, but which garlic or ginger supplement or placebo will the participants take? They will not be informed.</study_design>
      <phase>3</phase>
      <hc_freetext>Checking the level of C-reactive protein or CRP.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Control group: First intervention group: Ginger supplement group produced by Gol Daro Pharmaceutical Factory (n=7) which is taken in the form of 1 gram of dry ginger in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch with 250 ml of water. The second experimental group: the garlic supplement group produced by Gol Daro pharmaceutical factory (n=7), which is consumed in the form of 1 gram of garlic powder in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch, along with 250 ml of water for two days. Intervention 2: Control group: The third experimental group: the placebo group will take 1 gram of starch powder produced by Gol Daro pharmaceutical factory in the form of 2 capsules of 500 mg with 2 meals of breakfast and lunch with 250 ml Water.</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>Fatemeh Soltanifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2 ،shalizr Alley.Shalizar sharghi Ave.Nowshahr</address>
        <city>Nowshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4651114875</zip>
        <telephone>+98 11 5235 6473</telephone>
        <email>soltanifarfatemeh1@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Soltanifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2 ،shalizr Alley.Shalizar sharghi Ave.Nowshahr</address>
        <city>Nowshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4661619373</zip>
        <telephone>+98 11 5235 6473</telephone>
        <email>soltanifarfatemeh1@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>BMI(body mass index) in the overweight range of 26 to 30 years old</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Using steroidal and non-steroidal anti-inflammatory drugs for at least 2 months before
History of sports activity in the last 6 months
Absence of diseases
Refusal or any sensitivity to taking the desired supplements</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Control group: First intervention group: Ginger supplement group produced by Gol Daro Pharmaceutical Factory (n=7) which is taken in the form of 1 gram of dry ginger in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch with 250 ml of water. The second experimental group: the garlic supplement group produced by Gol Daro pharmaceutical factory (n=7), which is consumed in the form of 1 gram of garlic powder in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch, along with 250 ml of water for two days.</i_keyword>
      <i_keyword>Control group: The third experimental group: the placebo group will take 1 gram of starch powder produced by Gol Daro pharmaceutical factory in the form of 2 capsules of 500 mg with 2 meals of breakfast and lunch with 250 ml Water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of change in the blood level of C-reactive protein or (CRP). Timepoint: Blood measurement of C-reactive protein or (CRP) level before starting the intervention, 14 days after taking garlic or ginger supplement. Method of measurement: Measurement in a blood sample (blood test).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of C-reactive protein or (CRP). Timepoint: Blood measurement of C-reactive protein or (CRP) level before starting the intervention, 14 days after taking garlic or ginger supplement. Method of measurement: Measurement in a blood sample (blood test).</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-14</approval_date>
        <contact_name>Ethics Commitee of Islamic AzadUniversity .Tunkabon branch</contact_name>
        <contact_address>Killometer 3 Chalus-Wali Abad roadTtunkabon Islamic Azad University complex Tunkabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
