<?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>IRCT20191126045514N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-14</date_registration>
      <primary_sponsor>Tarbiat modares University</primary_sponsor>
      <public_title>The effect of turmeric on the treatment of women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The survery of Turmeric Extract effect on Serum Adiponectin Levels and the FerrimanGallwey Scoring System of Hirsutism in PCOS Women; a Randomized Double-blind ClinicalTrial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43821</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization of an individual with an envelope in dividing the groups into two groups A and B. In this method, we selected a number of cards or letters as the intervention group and the same number of cards for the control group, then merged the cards together. One card was taken out and its allocation was recorded, and after the card was taken out, we returned it again to all the other cards. Then the cards are merged again and we take out another card. This process continues until a random sequence is reached according to the sample size, Blinding description: The present study is a double-blind study and the researcher and the patient will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by a third party. The main researcher intervenes patients in a double-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form.
 Intervention in the PCOS target group will be using the usual treatment (metformin) with turmeric extract for 8 weeks at a rate of 100 kg / mg
Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups
A venous blood sample will be taken.</study_design>
      <phase>2</phase>
      <hc_freetext>PCOS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The usual treatment (metformin) with turmeric extract will be 100 mg / kg for 8 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran. Intervention 2: Control group: the usual treatment (metformin) and placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using , women in both groups will have venous blood sampling again.</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:
Only part of the information

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Scientific and research studies

Where to obtain:
Mobarakeh.mazareei@modares.ac.ir
mobarakeh72mazareei@gmail.com

How to obtain:
one week until one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Tehranian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Jalal Al Ahmad, Paul Nasr, Tarbiat Modarres University</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8800 6544</telephone>
        <email>tehranian@modares.ac.ir</email>
        <affiliation>tarbiat modares university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh tehranian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Jalal Al Ahmad, Paul Nasr, Tarbiat Modarres University</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8800 6544</telephone>
        <email>tehranian@modares.ac.ir</email>
        <affiliation>tarbiat modares university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 35-18 years
Be Iranian and Persian language 
Satisfaction of the person to enter the study
Without any history of abortion and cesarean delivery
No medical problems such as diabetes and high blood pressure, psychological diseases, infections and other pelvic pathologies and other medical problems.
Have spent the past six months without severe psychological stress
Diagnosis of polycystic ovary syndrome based on Rotterdam criteria and approval by a gynecologist
No alcoholism and no history of alcohol and drug use
The diet is normal.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A person with polycystic ovary disease is taking a drug other than metformin</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The usual treatment (metformin) with turmeric extract will be 100 mg / kg for 8 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran</i_keyword>
      <i_keyword>Control group: the usual treatment (metformin) and placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using , women in both groups will have venous blood sampling again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum adiponectin levels. Timepoint: Befor and 8 WEEKS After intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Hirsutism status based on Freeman Galloway score. Timepoint: Befor and 8 WEEKS After intervention. Method of measurement: View and score based on Freeman Galloway score.</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>Tarbiat modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Ethics committee of Tarbiat modares University</contact_name>
        <contact_address>Tehran jalal al ahmad Ave tarbiat modares university TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
