<?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>IRCT20090422001836N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-21</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison The Therapeutic Effect Of Curcumin Nanomicelle And Metformin In Women With Polycystic Ovarian Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison The Therapeutic Effect of Curcumin Nanomicelle And Metformin In Women With Polycystic Ovarian Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41192</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation Software Was Used For Block Randomization And RANUNI And RANNOR Functions Were Used To Generate Random Numbers, Blinding description: Patients And Statistics Experts Are Kept Blind In This Study. It Should Be Noted That All Patients Received Current And Accepted Treatment For Their Disease, And No Patients Was Excluded From Conventional Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Polycystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: The First Group (50 Patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times). Times Per Day For Three Months). Intervention 2: Intervention Group: Second Group  (50 patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times And Nano-Micelles Of Curcumin 80 Mg Once Daily For Three Months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Publishing patient information before publishing an article does not seem to be ethical</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3820 3419</telephone>
        <email>Smsohrevardi@kmu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mojtaba Sohrevardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3820 3419</telephone>
        <email>Smsohrevardi@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 18 to 40
Observe 12 Follicles Or More In Size Of 2-9 Mm In The Ovary By Ultrasound
Oligomenorrhea or Amenorrhea In The Last 6 Months
Testosterone Levels Above 0.7 ng/dl
Serum Insulin Levels Above 16 U/ml</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy And Lactation During The Last 90 Days And Discontinuation Of Medication During Treatment
Liver And Kidney Failure During The Last 90 Days And Discontinuation Of Medication During Treatment
Thyroid Dysfunction During The Last 90 Days And Discontinuation Of Medication During Treatment
Hyper Prolactinemia During The last 90 Days And Discontinuation Of Medication During Treatment
Adrenal Dysfunction During The Last 90 Days And Discontinuation Of Medication During Treatment
Congenital Adrenal Hyper Plasia During The Last 90 Days And Discontinuation Of Medication During Treatment
Cushing's Syndrome During The Last 90 Days And Discontinuation Of Medication During Treatment
Use Of Contraceptives During The Last 90 Days And Discontinuation Of Medication During Treatment
Taking Estrogen And Progesterone In The Last 90 Days And Discontinuing Medication During Treatment
Ovulation Induce Medication For The Last 90 Days And Discontinue Medication During Treatment
Use Of Anti-Androgen Drugs During The Last 90 Days And Discontinuation Of Medication During Treatment
Insulin Use During The Last 90 Days And Discontinuation Of Medication During Treatment</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: The First Group (50 Patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times). Times Per Day For Three Months)</i_keyword>
      <i_keyword>Intervention Group: Second Group  (50 patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times And Nano-Micelles Of Curcumin 80 Mg Once Daily For Three Months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Insulin Level. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: µU/ml.</prim_outcome>
      <prim_outcome>Low Density Lipoprotein. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: Mili Gram Per Deciliter.</prim_outcome>
      <prim_outcome>High Density Lipoprotein. Timepoint: Before Lntervention And After Intervention( After Three Month). Method of measurement: Mili Gram Per Deciliter.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: Mililgram Per Deciliter.</prim_outcome>
      <prim_outcome>Fast Blood Suger. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: Milligram Per Deciliter.</prim_outcome>
      <prim_outcome>17hydroxyprogestrone. Timepoint: Before Intervention And After Intervention( after three month). Method of measurement: Miligram Per Liter.</prim_outcome>
      <prim_outcome>Total Testosterone. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: Microgram Per Liter.</prim_outcome>
      <prim_outcome>LH/FSH Ratio. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: IU Per Liter.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before Intervention And After Intervention( After Three Month). Method of measurement: Milligram Per Deciliter.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-29</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
