<?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>IRCT20210217050393N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-28</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supplementation beetroot capsul with or without vitamin C on oxidative stress factors in patients with chronic coronary heart disease</public_title>
      <acronym></acronym>
      <scientific_title>Effect of supplementation beetroot capsul with or without vitamin C on serum fatty acids and oxidative stress factors in patients with chronic coronary heart disease. Double blind Randomized trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization
To apply randomization, the method of permuted block randomization with quadruple blocks will be used. In order to apply concealment in the randomization process, unique codes will be used on drug boxes, and the desired code will also be used by the online site. it is produced.
Concealed allocation using opaque envelopes, in closed, sealed and sequential, Blinding description: Concealed allocation using opaque envelopes, in closed, sealed and sequential.
Participants (lack of knowledge of intervention groups), Care providers (lack of knowledge of sample type assignment to groups), Investigator.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: 30 men and women with coronary heart disease received three 500 mg red beet capsules daily for 4 weeks each. Intervention 2: Intervention group 2 : 30 men and women with coronary heart disease received three 500 mg capsules of red beets and vitamin C daily for 4 weeks each. Intervention 3: Control group: Control group: 30 men and women with coronary heart disease received three placebo capsules a day for 4 weeks each, which is very similar in appearance and volume to the drug capsule.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Rezvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad university of medical sciences, Azadi squre</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>rezvanir@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Rezvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad university of medical sciences, Azadi squre</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>rezvanir@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Age 30 to 65 years
2.  Men and women with chronic coronary artery disease
3. Willingness to participate in research</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Do not consume more than 10% of capsules
2. The occurrence of any accident that affects a person's health
3. Having any acute illness during the study
4. Reluctance to continue cooperation in research
5. Body Mass Index more than 30 kg / m2
6. Acute heart accident in the past year
7.Taking any medicine outside the treatment protocol
8. Consumption of any herbal medicines
9. Allergy to red beet
10. Nitrate-containing drugs (such as nitroglycerin, isosorbide)
11. Using oral and injectable nutritional supplements for at least the last 4 months (vitamins D, C, E, calcium, magnesium, potassium and multivitamin-mineral, omega 3)
12. Disease (diabetes, kidney stones, gallstones, cancer and other chronic diseases)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_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 group1: 30 men and women with coronary heart disease received three 500 mg red beet capsules daily for 4 weeks each.</i_keyword>
      <i_keyword>Intervention group 2 : 30 men and women with coronary heart disease received three 500 mg capsules of red beets and vitamin C daily for 4 weeks each.</i_keyword>
      <i_keyword>Control group: Control group: 30 men and women with coronary heart disease received three placebo capsules a day for 4 weeks each, which is very similar in appearance and volume to the drug capsule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: At the beginning of the study and 28 days after consume red beet capsules. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>Myeloperoxidase. Timepoint: At the beginning of the study and 28 days after consume red beet capsules. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: At the beginning of the study and 28 days after consume red beet capsules. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>Total Oxidant Status. Timepoint: At the beginning of the study and 28 days after consume red beet capsules. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>Saturated fatty acids. Timepoint: At the beginning of the study and 28 days after consume red beet. Method of measurement: Gas Chromatography.</prim_outcome>
      <prim_outcome>Polyunsaturated fatty acids. Timepoint: At the beginning of the study and 28 days after consume red beet. Method of measurement: Gas Chromatography.</prim_outcome>
      <prim_outcome>Monounsaturated fatty acids. Timepoint: At the beginning of the study and 28 days after consume red beet. Method of measurement: Gas Chromatography.</prim_outcome>
      <prim_outcome>Fatty acid indices. Timepoint: At the beginning of the study and 28 days after consume red beet. Method of measurement: Calculation through other fatty acids.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist circumference. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: tape measure.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: tape measure.</sec_outcome>
      <sec_outcome>Neck circumference. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: tape measure.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: Bioelectrical Impedance Analysis(BIA).</sec_outcome>
      <sec_outcome>Fat mass. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: Bioelectrical Impedance Analysis(BIA).</sec_outcome>
      <sec_outcome>Free fat mass. Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: Bioelectrical Impedance Analysis(BIA).</sec_outcome>
      <sec_outcome>Body Mass Index(BMI). Timepoint: At the beginning of the study and 28 days after the intervention. Method of measurement: Bioelectrical Impedance Analysis(BIA).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-31</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>faculty of Medicine, East door of Ferdowsi University, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
