<?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>IRCT20150905023897N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-09</date_registration>
      <primary_sponsor>Tarbiat modares University</primary_sponsor>
      <public_title>To evaluate the effect of garlic tablet on metabolic syndrome in PCOS patients : A Randomized Double-blind Placebo-controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>To evaluate the effect of garlic tablet on metabolic syndrome in PCOS patients : A Randomized Double-blind Placebo-controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42316</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups according to the blocking method and double blind, Blinding description: The researcher and patient will be unaware of the treatment and grouping of the study. For this purpose, Garlic tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form, and the researcher who completes the information form will not be informed of the type of treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Metabolic syndrome in PCOS patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment by garlic tab 500 mg. Intervention 2: Control group: treatment by placebo of garlic tab.</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 on the main outcome of the study

When:
1400

To whom:
Academic researchers

Conditions:
Use for further research in the future

Where to obtain:
Email Addressing Responsible for Study

How to obtain:
Submit a request to study and follow up

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahideh Jahanian Sadatmahalleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal E Al Ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۱۷۱۳۱۱۶</zip>
        <telephone>+98 21 2230 6480</telephone>
        <email>Shahideh.jahanian@modares.ac.ir</email>
        <affiliation>Tarbiat modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahideh Jahanian Sadatmahalleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal E Al Ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۱۷۱۳۱۱۶</zip>
        <telephone>+98 21 2230 6480</telephone>
        <email>shahideh.jahanian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People are willing to participate in the study
fertility age between 15-49 years
Iranian women
no pregnancy
have at least literacy for read and write
no Mellitus Diabets according to primary FBS
no chronic and coagulation disorders
lack of consumption Anti lipids and Anti hypertensive and anti coagulative drugs
no consuming garlic in a daily diet more than one cubit</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with drug side effects.Individuals unwilling to continue to participate in the study failure to comply with treatment protocol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Treatment by garlic tab 500 mg</i_keyword>
      <i_keyword>Control group: treatment by placebo of garlic tab</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Triglyceride. Timepoint: First of study and 8 weeks after intervention. Method of measurement: blood biochemistry test.</prim_outcome>
      <prim_outcome>Level of cholesterol. Timepoint: First of study and 8 weeks after intervention. Method of measurement: blood biochemistry test.</prim_outcome>
      <prim_outcome>Blood level of HDL. Timepoint: First of study and 8 weeks after intervention. Method of measurement: blood biochemistry test.</prim_outcome>
      <prim_outcome>Blood level of FBS. Timepoint: First of study and 8 weeks after intervention. Method of measurement: blood biochemistry test.</prim_outcome>
      <prim_outcome>Level of systolic and diastolic blood pressure. Timepoint: First of study and 8 weeks after intervention. Method of measurement: Use of mercury barometer.</prim_outcome>
      <prim_outcome>Waist to hip ratio. Timepoint: First of study and 8 weeks after intervention. Method of measurement: Use of meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of CRP. Timepoint: First of study and 8 weeks after intervention. Method of measurement: Blood biochemistry test.</sec_outcome>
      <sec_outcome>Menstrual dysfunction such as: Oligomenorrhea and amenorrhea. Timepoint: First of study and 8 weeks after intervention. Method of measurement: patient statements.</sec_outcome>
      <sec_outcome>Clinical hyperandrogenemia. Timepoint: First of study and 8 weeks after intervention. Method of measurement: Blood biochemistry test and clinical symptom.</sec_outcome>
      <sec_outcome>Ultrasound view of the ovaries. Timepoint: First of study and 8 weeks after intervention. Method of measurement: Use of ultrasound.</sec_outcome>
      <sec_outcome>Sexual function. Timepoint: First of study and 8 weeks after intervention. Method of measurement: FSFI questionnaire.</sec_outcome>
      <sec_outcome>Quality Of life. Timepoint: First of study and 8 weeks after intervention. Method of measurement: MPCOSQ questionnaire.</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>2019-11-02</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares university</contact_name>
        <contact_address>Jalal E Al Ahmad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
