<?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>IRCT20190122042458N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-04</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Grape Seed Extract  Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome</public_title>
      <acronym>GSE-PCOS</acronym>
      <scientific_title>The Effect of Grape Seed Extract (GSE) Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome (PCOS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants Do not know Which Control Groups or Witness Group are Located.
Investigator and Attending Medical Personnel and Data Collectors Do not know the Presence of Participants In the Witness Group or Control Group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic Ovary Syndrome(PCOS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Includes 25 Patients Who Will be Randomly Selected and Treated With Placebo Orally For Two Months. Intervention 2: Control Group: Includes 25 Patients Who Will be Treated With Grape Seed Dupplements For Two Months, Supplemented By Grape Seed Purchased From Shari Drug Company, Which Will Be Given 250 mg Orally Daily.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After Collecting the Data in the Form of the Final Report of the Dissertation, it Will be Available to Ahwaz University of Medical Sciences.

When:
Start of Access 3 Months After Printing Results

To whom:
Project Implementers

Conditions:
Based on the laws of Ahwaz University of Medical Sciences

Where to obtain:
Ahwaz University of Medical Sciences

How to obtain:
Ahwaz University of Medical Sciences Assistant Professor of Nutrition

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pegah Sedighii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Hospital</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1859313336</zip>
        <telephone>+98 21 3360 5280</telephone>
        <email>Amiraryan89@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pegah Sedighii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Haspitan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1859313336</zip>
        <telephone>+98 21 3360 5280</telephone>
        <email>amiraryan89@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of Admission 25 to 60 Years
Body Mass Index Less than or Equal to 30
Diagnosis of Women with Polycystic Ovarian Syndrome Defined as Presence of 2 Characteristics of the Following 3 Characteristics: Oligoavulation or non Ovulation, Biochemical and / or Clinical Evidence of Hyperandrogenism, Features of Transvaginal Ultrasonography Representing More than 12 Immature Follicles Less than 10 mm Per Ovary</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness of Patients to Participate in the Study
Kidney Disease, Coronary Arteries, Acute and Chronic Pulmonary Inflammation, Short Stomach and Intestine Syndrome, Allergies
Pregnancy and Lactation
Traveling for More than 2 Weeks
Smokers
Use of Food Supplements
Anti-Inflammatory Drugs
Use of any Antioxidant Supplement in the Last 3 Months
Use of Immunosuppressive Drugs
Follow Certain Diets
Change the Diet or Decide to Lose Weight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P05.08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Newborn light for gestational age, 2000-2499 grams</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Includes 25 Patients Who Will be Randomly Selected and Treated With Placebo Orally For Two Months.</i_keyword>
      <i_keyword>Control Group: Includes 25 Patients Who Will be Treated With Grape Seed Dupplements For Two Months, Supplemented By Grape Seed Purchased From Shari Drug Company, Which Will Be Given 250 mg Orally Daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HDL. Timepoint: 0-60. Method of measurement: Laboratory Kits.</prim_outcome>
      <prim_outcome>LDL. Timepoint: 0-60. Method of measurement: Laboratory Kits.</prim_outcome>
      <prim_outcome>T.G. Timepoint: 0-60. Method of measurement: Laboratory Kits.</prim_outcome>
      <prim_outcome>FBS. Timepoint: 0-60. Method of measurement: Laboratory Kits.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: 0-60. Method of measurement: Laboratory Kits.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: 0-60. Method of measurement: Laboratory Kits.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-24</approval_date>
        <contact_name>IR.AJUMS.REC.1398.236</contact_name>
        <contact_address>Golestan -hospital Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
