<?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>IRCT20200408046987N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-27</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Resveratrol on some biochemical and hormonal factors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Resveratrol on some biochemical and hormonal factors in university staff</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56958</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this study, a simple randomization method is used and a list of random numbers is created with Randomizer software. The software randomly divides this list from 1 to 80 between the control and intervention groups. Depending on the order of patients' referrals, they are given a number from 1 to 80 from the list of random numbers, and based on the list created by the software, which assigns each number to one of the two control and intervention groups, people enter the intervention or control group. be, Blinding description: Participants will be given medication or placebo after signing the consent form. The therapist and outcome assessor will not know the type of treatment, and the data analyzer will only know the group numbers.</study_design>
      <phase>3</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People in this group take Resveratrol (An active compound of acetylene phytoalexin) capsule supplements once a day before meals for a month. Intervention 2: Control group: People in this group take one 1000 mg capsule containing wheat flour instead of Resveratrol every day for a month before a meal.</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 .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nematollah Gheibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3332 8212</telephone>
        <email>ngheibi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nematollah Gheibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahinar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3332 8212</telephone>
        <email>ngheibi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People between 18 to 50 years old
Complete consent of individuals to participate in the study
Having a BMI of 25 to 30 kg/m²</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People having any allergies to the drug
People with diabetes
People with a history of high fat under treatment
People taking vitamins and supplements
People taking herbal medicines
Patients with a history of inflammatory disease being treated
People with known liver and kidney disease
People with known lipid disease
People treated with corticosteroids, aspirin and anti-lipids and hormonal drugs, hyperthyroidism and hypothyroidism
People on drug treatment related to metabolic syndrome</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>Intervention group: People in this group take Resveratrol (An active compound of acetylene phytoalexin) capsule supplements once a day before meals for a month.</i_keyword>
      <i_keyword>Control group: People in this group take one 1000 mg capsule containing wheat flour instead of Resveratrol every day for a month before a meal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of fasting Insulin. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by Snible kit.</prim_outcome>
      <prim_outcome>Measuring the mass of fat accumulated in the body. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, the amount of accumulated fat will be measured with a digital scale.</prim_outcome>
      <prim_outcome>Measurement of Follicle Stimulating Hormone. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by Snible kit.</prim_outcome>
      <prim_outcome>Measurement of Luteinizing hormone. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by Snible kit.</prim_outcome>
      <prim_outcome>Measurement of  Dehydroepiandroterone. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by Snible kit.</prim_outcome>
      <prim_outcome>Measurement of  Anti Mullerian hormone. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Insulin-like growth factor 1. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Interleukin 6. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Self-monitoring of blood glucose. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Testosterone. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of White Blood Cell. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by cell counter.</prim_outcome>
      <prim_outcome>Measurement of Lymphocyte. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by cell counter.</prim_outcome>
      <prim_outcome>Measurement of Neutrophil. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by cell counter.</prim_outcome>
      <prim_outcome>Measurement of Platelet. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by cell counter.</prim_outcome>
      <prim_outcome>Measurement of Body Mass Index. Timepoint: Before starting intervention and one month after intervention. Method of measurement: Weight (in kilograms) Divided by Height (in meters to the power of 2).</prim_outcome>
      <prim_outcome>Measurement of High-Sensitivity C-Reactive Protein. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by Rosh kit (in mg/dL).</prim_outcome>
      <prim_outcome>Measurement of Low-density lipoprotein. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of High-density lipoprotein. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Triglyceride. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Total Antioxidant. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Fasting Blood Sugar. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</prim_outcome>
      <prim_outcome>Measurement of Homeostatic Model Assessment for Insulin Resistance. Timepoint: Before starting intervention and one month after intervention. Method of measurement: At the beginning and end of the study, it will be measured by kit.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-15</approval_date>
        <contact_name>Qazvin university of medical sciences</contact_name>
        <contact_address>Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
