<?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>IRCT20100408003664N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-07</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of cinnamon supplementation on antioxidant status in patients with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cinnamon supplementation on antioxidant status in patients with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables, Blinding description: A placebo and supplement will be packed in the same number in similar envelopes. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic Ovarian Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3 capsules of 500 mg cinnamon daily for 8 weeks. Intervention 2: Control group: Plasebo: 3 capsule 500 mg daily, 8 weeks.</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 The final decision will be taken after the end of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Borzoie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+41 33357581</telephone>
        <email>s_borzoie@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Borzoie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sience, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7581</telephone>
        <email>s_borzoie@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Female:20-38 years old, 25≤BMI&gt;40; At least two standard measurement  of amenorrhea or oligomenorrhea; Clinical or laboratory hyperandrogenism and polycystic ovary  on ultrasonography .</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: Thyroid disorders; Hyperprolactinemia, Cushing's syndrome;  Liver and kidney diseases; Cardiovascular disease; High blood pressure and diabetes; Pregnant and lactation women;  Consumers of anti-obesity  and blood lipid-lowering drugs;  Anticoagulants and glucocorticoids drugs; Loss wieght diet; smokers; Very active and athletes; Allergic to cinnamon; Seizure and epilepsy disorders ; Cerebrovascular disorders; Individuals undergoing infertility treatments  and beta-blockers.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 3 capsules of 500 mg cinnamon daily for 8 weeks.</i_keyword>
      <i_keyword>Control group: Plasebo: 3 capsule 500 mg daily, 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde (MDA). Timepoint: Begining and end of the intervention. Method of measurement: Serum kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity(TAC). Timepoint: Begining and end of the intervention. Method of measurement: Serum kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity. Timepoint: Beginning and end of intervention. Method of measurement: questioner.</sec_outcome>
      <sec_outcome>Diet. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: 3-day food record.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-10</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
