<?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>IRCT20120913010826N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of high protein-low carbohydrate weight loss diet with fennel supplement in women with polycystic ovary syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of high protein-low carbohydrate weight loss diet with fennel supplement on androgens and anthropometric indices in overweight and obese women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11256</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Individuals were randomly assigned to four intervention groups using a randomized table: 1-high proteine- low carohydrate diet weight loss diet with fennel, 2-high proteine- low carohydrate diet weight loss diet with placebo 3-standard weight loss diet with fennel, 4-standard weight loss diet with 
placebo, Blinding description: Prescribing supplement and placebo by a researcher without knowledge of its type, as well as taking it by the participants in the study without their 
knowledge. There is no possibility of blindness for the diet.In order to minimize bias in the intervention, one researcher randomly assigns random access to the patient in a randomized manner, without any knowledge of the patient's condition, and the other investigator who is associated with the patient, will place that person in the designated group.</study_design>
      <phase>3</phase>
      <hc_freetext>polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Prescribe high protein- low carbohydrate weight loss diet with 2 fennel capsule per day. Intervention 2: Intervention group 2: prescribe high protein-low carbohydrate weight loss diet with 2 placebo capsule per day. Intervention 3: Control  group 1: prescribe Standard weight loss diet (The amount of energy needed by each individual will be calculated using an ideal weight of BMI 22 to 23 kg / m2, and 500 calories will be deducted from the total energy required with 2 fennel capsule per day. Intervention 4: Control group 2: prescribe Standard weight loss diet with 2 pelacebo capsul per day.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Data report will be shared after publishing the paper.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Hosseini Marnani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>Elham_Hosseini1993@yahoo.com</email>
        <affiliation>دانشگاه علوم پزشکی یزد</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Azadeh Nadjarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>azadehnajarzadeh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>polycystic ovary syndrome based on the Rotterdam criteria, at least two criteria of the three following criteria: 1) anovulation or oligo- ovulation or menstrual cycle less than 6 times in 12 months. 2) Clinical or biochemical increase in androgens, including the presence of acne, hirsutism, alopecia or serum levels of androgens . 3) Polycystic view with 12 or more follicles in each ovary with a diameter of between 3-2Myly meters or ovarian volume increased more than 11 cm
overweight or obese (BMI greater than or equal to 25)
aged 18-45 years
willing to participate in this study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The other causes of hyperandrogenism، Congenital adrenal hyperplasia، Cushing, hypothyroidism, hyperprolactinemia, and Androgen-secreting tumors and those with hirsutism, acne or severe hair loss
Allergy to anise or any of its components
pregnant women and people who desire to pregnancy
allergic asthma
seizures
liver and renal (urea and creatinine above the normal range) disease
cancer</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>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Prescribe high protein- low carbohydrate weight loss diet with 2 fennel capsule per day</i_keyword>
      <i_keyword>Intervention group 2: prescribe high protein-low carbohydrate weight loss diet with 2 placebo capsule per day</i_keyword>
      <i_keyword>Control  group 1: prescribe Standard weight loss diet (The amount of energy needed by each individual will be calculated using an ideal weight of BMI 22 to 23 kg / m2, and 500 calories will be deducted from the total energy required with 2 fennel capsule per day.</i_keyword>
      <i_keyword>Control group 2: prescribe Standard weight loss diet with 2 pelacebo capsul per day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total Testosterone. Timepoint: befor and after 12 weeks treatment. Method of measurement: Using ELISA.</prim_outcome>
      <prim_outcome>SHBG(Sex hormone-binding globulin). Timepoint: befor and after 12 weeks treatment. Method of measurement: Using ELISA.</prim_outcome>
      <prim_outcome>Weight. Timepoint: befor and after 12 weeks treatment. Method of measurement: Scale.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: befor and after 12 weeks treatment. Method of measurement: Meter.</prim_outcome>
      <prim_outcome>Hip circumfernce. Timepoint: befor and after 12 weeks treatment. Method of measurement: Meter.</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>2017-07-17</approval_date>
        <contact_name>Yazd university of Medical Sciences</contact_name>
        <contact_address>Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-17</approval_date>
        <contact_name>Ethics committee of Yazd University of Sciences</contact_name>
        <contact_address>آدرس خیابان Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
