<?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>IRCT2017020732439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-17</date_registration>
      <primary_sponsor>Research Associate, Faculty of Nutrition and Food Sciences</primary_sponsor>
      <public_title>Evaluating the effect of consumption of synbiotic pomegranate juice in women with poly cystic ovarian syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of consumption of synbiotic pomegranate juice on glycemic markers, oxidative stress, inflammation and androgen profile of women with poly cystic ovarian syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25272</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: We randomly assigned patients to a ratio of 1: 1: 1: 1 to 4 groups. A scholar who did not have any clinical intervention in intervention,  randomly classified the patient by random blocking software with a fixed block size of 4 in randomized group&#13;
 In order to blind patients, the drinks in all groups are identical in appearance, color and taste. The drinks are coded deffrently in each group and then will be given to scholar to blinding the scholar. Finally, the data and information are also given to the analyzer by the special code for each group in order to be blinded analayzer.</study_design>
      <phase>N/A</phase>
      <hc_freetext>poly cystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: 1. Patients who receive 2 liters of pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks. Intervention 2: 2.  Patients who receive 2 liters of pomegranate juice each week, in the form of disposable bottles for 8 weeks. Intervention 3: 3.  Patients who receive 2 liters of synbiotic juice each week, which consists of  inulin, lactobacillus and pomegranate flavor, in the form of disposable bottles for 8 weeks. Intervention 4: 4.  Patients who receive 2 liters of placebo juice each week, which consists of pomegranate flavore, in the form of disposable bottles for 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Esmaeilinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East saheli</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3225 6271</telephone>
        <email>sahar.esnj8@gmail.com</email>
        <affiliation>Food and nutrion science university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Esmaeilinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East saheli</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3225 6271</telephone>
        <email>sahar.esnj8@gmail.com</email>
        <affiliation>Zahra Esmaeilinezhad, Department od clinical nutrition, Shiraz university of medical science, School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria&#13;
&#13;
PCOS could be diagnosed, according to the ROTTERDAM criteria, by two of the following three features: &#13;
1) Oligomenorrhea (Less Than 6-9 Menses per Year) or amenoria (Non-vaginal bleeding for at least 6 months)&#13;
2) Clinical Hyperandrogenism (Hirsutism score higher than 8 or obviose acne) or increase blood testosterone levels (Testosterone levels above2 nmo/l)&#13;
 3) Polycystic Ovaries on Ultrasound (The presence of 12 or more cysts with a diameter of 9.2 mm in one or both ovaries or the size of the ovary 10 cm3 or more)&#13;
&#13;
BMI&gt;18&#13;
Having permission the doctor and informed consent to participate in the study&#13;
&#13;
Not Inclusion criteria:&#13;
Other medical conditions related to excess androgens such as increased blood prolactin, nonclassical congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumors and acromegaly&#13;
wemon with severe diseases of the stomach, intestines, heart, kidney, liver, lung, chronic, autoimmune, inflammatory and AIDS&#13;
Patients undergoing chemotherapy&#13;
smokers&#13;
Lactating women&#13;
Patients treated with corticosteroids and antibiotics&#13;
The use of supplements of vitamins, minerals and antioxidants&#13;
Those taking hormone pills or supplements&#13;
Patients using insulin to treat diabetes&#13;
Patients with a special diet&#13;
Patients with specific exercise program&#13;
&#13;
Exclusion citeria:&#13;
Lack of any of the compounds at a rate of more than 4 days a week&#13;
The loss of any of the inclusion criteria</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>48 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>Polycystic ovarian syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. Patients who receive 2 liters of pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks.</i_keyword>
      <i_keyword>2.  Patients who receive 2 liters of pomegranate juice each week, in the form of disposable bottles for 8 weeks.</i_keyword>
      <i_keyword>3.  Patients who receive 2 liters of synbiotic juice each week, which consists of  inulin, lactobacillus and pomegranate flavor, in the form of disposable bottles for 8 weeks.</i_keyword>
      <i_keyword>4.  Patients who receive 2 liters of placebo juice each week, which consists of pomegranate flavore, in the form of disposable bottles for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric method.</prim_outcome>
      <prim_outcome>Fasting plasma insulin. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).</prim_outcome>
      <prim_outcome>Insulin resistante. Timepoint: before and 2 month after intervention. Method of measurement: HOMA-IR.</prim_outcome>
      <prim_outcome>Insulin sensivity. Timepoint: before and 2 month after intervention. Method of measurement: QUICKI.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).</prim_outcome>
      <prim_outcome>MDA. Timepoint: before and 2 month after intervention. Method of measurement: biochemichal method.</prim_outcome>
      <prim_outcome>TAC. Timepoint: before and 2 month after intervention. Method of measurement: calorimetric.</prim_outcome>
      <prim_outcome>DHEAS. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).</prim_outcome>
      <prim_outcome>Testosterone. Timepoint: before and 2 month after intervention. Method of measurement: Enzyme-linked immunosorbent assay ( ELISA ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mensturation cycle. Timepoint: before and 2 month after intervention. Method of measurement: questionare.</sec_outcome>
      <sec_outcome>Hirsutism. Timepoint: before and 2 month after intervention. Method of measurement: questionare.</sec_outcome>
      <sec_outcome>Alopecia. Timepoint: before and 2 month after intervention. Method of measurement: questionare.</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>Research Associate, Faculty of Nutrition and Food Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-22</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>razi street shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
