<?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>IRCT20210515051298N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-09</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index</public_title>
      <acronym></acronym>
      <scientific_title>Effect of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index, insulin sensitivity and depression, anxiety and stress in polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56333</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher will use a table of random numbers to select the sample. It randomly starts from a point in the table in the direction of a row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. The movement does not differ in the direction of the row or column, and this is up to the researcher. But according to the type of code digits (one digit, two digits, three digits, etc.) he must select the same number of digits in the row or column direction. It then controls the route numbers. He will inevitably encounter two types of numbers, one of which is smaller than the number of the population of the study and the other of which is larger than the number of the population. He should only consider and select smaller numbers. The selected number is in fact the individual code of the community that is selected as a sample. This should be continued until a small number can be selected based on the number of sample people. After completing the sample size, the sampling work is completed.For this study, 80 sealed ‎envelopes will be numbered 1-120 according to the randomization list. Group allocation ‎will be kept separate until the study is completed. with 40 ‎envelopes allocated to each group, Blinding description: This study is double-blind ,after completing the study and collecting the results, the relevant codes will be provided to each patient team and the method of performing the double-blind nature of the study was such that neither the patient nor the researcher were aware of patient allocation. They were similarly packaged to avoid identification.</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Chromium supplement 400 micrograms of CENTURY company daily orally for two months. Intervention 2: Intervention group 2: Chromium supplement 600 micrograms daily of CENTURY company orally for two months. Intervention 3: Control group: Oral placebo tablets once daily for two months of Darupakhsh Company.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Belghese Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>mohammadi.b@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Belghese Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>009891332220016</telephone>
        <email>mohammadi.b@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction of patients aged 16 to 40 years
Polycystic Ovary Syndrome</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Take chromium picolinate supplement regularlyHydroxy
Progesterone above 2</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Chromium supplement 400 micrograms of CENTURY company daily orally for two months</i_keyword>
      <i_keyword>Intervention group 2: Chromium supplement 600 micrograms daily of CENTURY company orally for two months</i_keyword>
      <i_keyword>Control group: Oral placebo tablets once daily for two months of Darupakhsh Company</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body mass index. Timepoint: Two months after the start of the intervention. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Insulin sensitivity. Timepoint: Two months after the start of the intervention. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Two months after the start of the intervention. Method of measurement: Questionaire.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-20</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
