<?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>IRCT20180503039511N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-21</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Curcumin on Polycystic Ovary Syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Curcumin supplementation on Mood Disorders, Lipid, Glycemic and Oxidative Stress Indexes, High-Sensitivity C-reactive Protein, in Women with Polycystic Ovary Syndrome(PCOS).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31036</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Use the randomized block model (random number table) and place each referral in the intervention or control group, Blinding description: In this study, the patients and the physician and the people who will perform the tests will not be aware of the fact that the person is using Curcumin supplement or placebo, and only the investigator and data analyst will know how to blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For 30 patients with Polycystic Ovarian Syndrome, selected by a specialist based on the Rotterdam index, a written consent is given after explaining the topic of the study. In this double-blind clinical trial, 500 mg Curcumin supplement, Karen Yazd, a pure extract of 95% turmeric, are recommended to take two capsules daily (1 g / day) with food.The duration of the intervention is 6 weeks and patients are taken from the patients at the beginning and the end of the intervention by fasting blood samples.Meanwhile, people respond to fill in short international physical activity questionnaires and depression, anxiety and stress personally, as well as the form of food intake, and after explaining how to write their diet, we ask them to bring them in next time. Intervention 2: Control group: Control group:  For 30 patients with Polycystic Ovarian Syndrome, selected by a specialist based on the Rotterdam index, a written consent is given after explaining the topic of the study. In this double-blind clinical trial, Placebo (starch) in the same shape and packaging, Iran, Karen Yazd, recommends daily consumption of two capsules (1 g / day) with food.The duration of the intervention is 6 weeks and patients are taken from the patients at the beginning and the end of the intervention by fasting blood samples.Meanwhile, people respond to fill in short international physical activity questionnaires and depression, anxiety and stress  personally, as well as the form of food intake, and after explaining how to write their diet, we ask them to bring them in next time.</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:
Information about Depression  Anxiety Stress Scale Questionnaire.

When:
6 months after printing results

To whom:
Researchers of Scientific references.

Conditions:
Data will only be used in the area of their subject matter.

Where to obtain:
s.sohaei@nutr.ac.ir
09058798237
983136681378+
Sara Sohaei
Isfahan, Azadi Square, School of Nutrition

How to obtain:
They will send the message to the email after 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Sohaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, School of Nutrition</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3773 5516</telephone>
        <email>s.sohaei@nutr.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Sohaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, School of Nutrition</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3773 5516</telephone>
        <email>s.sohaei@nutr.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>PCOS diagnosis by a Specialist (Base on Rotterdam benchmark)
Women aged 18 to 40 Years Old (It is preferable not to be at the Age of Development or Menopause).
Body mass index larger equal to 25, smaller and equal to 35.
stability in the type and dose of medication in the last 6 months.
Lack of acute heart disease, Increased Prolactin levels, Liver, Kidney, Digestive, Thyroid and Diabetes, Androgens secreting Tumors.
Use of antioxidant supplements and drugs that affect inflammatory and oxidative stress factors.
Drug in the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwilling to participate in the study
Pregnancy
Misdiagnosis of demographic or anthropometric information</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: For 30 patients with Polycystic Ovarian Syndrome, selected by a specialist based on the Rotterdam index, a written consent is given after explaining the topic of the study. In this double-blind clinical trial, 500 mg Curcumin supplement, Karen Yazd, a pure extract of 95% turmeric, are recommended to take two capsules daily (1 g / day) with food.The duration of the intervention is 6 weeks and patients are taken from the patients at the beginning and the end of the intervention by fasting blood samples.Meanwhile, people respond to fill in short international physical activity questionnaires and depression, anxiety and stress personally, as well as the form of food intake, and after explaining how to write their diet, we ask them to bring them in next time.</i_keyword>
      <i_keyword>Control group: Control group:  For 30 patients with Polycystic Ovarian Syndrome, selected by a specialist based on the Rotterdam index, a written consent is given after explaining the topic of the study. In this double-blind clinical trial, Placebo (starch) in the same shape and packaging, Iran, Karen Yazd, recommends daily consumption of two capsules (1 g / day) with food.The duration of the intervention is 6 weeks and patients are taken from the patients at the beginning and the end of the intervention by fasting blood samples.Meanwhile, people respond to fill in short international physical activity questionnaires and depression, anxiety and stress  personally, as well as the form of food intake, and after explaining how to write their diet, we ask them to bring them in next time</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: The beginning and the end of the study. Method of measurement: Biochemistry.</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity. Timepoint: The beginning and the end of the study. Method of measurement: Biochemistry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean changes in the level of the C reactive protein. Timepoint: The beginning and the end of the study. Method of measurement: Biochemistry.</sec_outcome>
      <sec_outcome>Depression anxiety stress score. Timepoint: The beginning and the end of the study. Method of measurement: Stress Anxiety Depression Questionnaire 7 question.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-09</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nutrition and Food Sciences., Hezar-Jerib St.,  Azad Square. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
