<?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>IRCT2013112515536N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of quercetin on PCOS patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of supplementation of quercetin on inflammatory factor and adiponectin and&#13;
gene expression of its receptors in women’s PBMC with polycystic ovary&#13;
syndrome(PCOS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: to the intervention group Quercetin supplements , 1 g daily for 12 weeks as the two tablets of 500 mg after 2 main meals (breakfast and lunch)and should not be taken on an empty stomach. Intervention 2: Patients in the placebo group will receive 12 weeks of placebo quercetin.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Rezvan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The fourth floor (Department of Nutrition and Biochemistry)-School of Public Health,Tehran Universit of Medical Sciences, Poursina St-Qods St-Enghelab St-tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8897 4463</telephone>
        <email>neda.rezvan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Javad Hosseinzadeh-Attar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health-Tehran University of Medical Sciences-Poursina St-ghods st-keshavarz blv-tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 1395</telephone>
        <email>hosseinzadeh.mdphd@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  BMI 25 to 40 - the age range of 20-40 years - according to the Rotterdam conference, at least two of the three criteria listed as having the disease. Features include menstrual irregularities, or clinical symptoms and the presence of polycystic ovaries on ultrasound – Hyperandrogenism.&#13;
donot use drugs; contraceptive drugs, antihypertensive drugs lower blood lipid and anti-inflammatory drug- and willing to cooperate.&#13;
Exclusion criteria: Endocrine and metabolic diseases such as hypothyroidism and hyperthyroidism, androgen producing cancer, diabetes mellitus, adrenal hyperplasia and Cushing, ovarian tumor and Hyperprolactinaemia  - Smoking - Pregnancy - allergic reaction to supplements - Cancel patient to cooperate in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sclerocystic ovary syndrome Stein-Leventhal syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>to the intervention group Quercetin supplements , 1 g daily for 12 weeks as the two tablets of 500 mg after 2 main meals (breakfast and lunch)and should not be taken on an empty stomach.</i_keyword>
      <i_keyword>Patients in the placebo group will receive 12 weeks of placebo quercetin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum adiponectin. Timepoint: Before and after intervention. Method of measurement: Adiponectin ELISA Kit μg / ml.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tumor necrosis factor. Timepoint: Before and after intervention. Method of measurement: Serum concentrations of TNFα ELISA kit.</sec_outcome>
      <sec_outcome>C-reactive protein. Timepoint: Before and after intervention. Method of measurement: Serum levels of hs-CRP ELISA Kit.</sec_outcome>
      <sec_outcome>High-molecular weight  adiponectin levels. Timepoint: Before and after intervention. Method of measurement: Adiponectin ELISA Kit μg / ml.</sec_outcome>
      <sec_outcome>Glucose. Timepoint: Before and after intervention. Method of measurement: Serum ELISA Kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Before and after intervention. Method of measurement: Serum ELISA kit micro mol / l.</sec_outcome>
      <sec_outcome>Adenosine monophosphate-activated protein kinase. Timepoint: Before and after intervention. Method of measurement: Serum ELISA Kit.</sec_outcome>
      <sec_outcome>Adiponectin receptor 1. Timepoint: Before and after intervention. Method of measurement: RT-PCR.</sec_outcome>
      <sec_outcome>Adiponectin receptor 2. Timepoint: Before and after intervention. Method of measurement: RT-PCR.</sec_outcome>
      <sec_outcome>Testosterone. Timepoint: Before and after intervention. Method of measurement: Serum Elisa kit.</sec_outcome>
      <sec_outcome>Progesterone. Timepoint: Before and after intervention. Method of measurement: serum Elisa kit.</sec_outcome>
      <sec_outcome>Luteinizing hormone. Timepoint: Before and after intervention. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Follicle stimulating hormone. Timepoint: Before and after intervention. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Sex Hormone Binding Globulin. Timepoint: Before and after intervention. Method of measurement: IRMA.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Pressure set.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Pressure set.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: Before and after intervention. Method of measurement: Serum total cholesterol concentration turbidometry mg / dl.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before and after intervention. Method of measurement: Serum triglyceride concentrations were enzymatically mg / dl.</sec_outcome>
      <sec_outcome>Low-density lipoprotein. Timepoint: Before and after intervention. Method of measurement: LDL-C levels.</sec_outcome>
      <sec_outcome>High-density lipoprotein. Timepoint: Before and after intervention. Method of measurement: Serum HDL cholesterol concentration.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tehran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-02-15</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth Floor-Central Tehran University-Qods St., Keshavarz Blvd-tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
