<?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>IRCT20181210041911N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the The Effect Of Evening Primrose On Blood Sugar And Lipid Profile In Pre-Diabetic Menopausal Women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the The Effect Of Evening Primrose On Blood Sugar And Lipid Profile In Pre-Diabetic Menopausal Women  Referred To Rafsanjan Comprehensive Health Services Centers In 1397</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization is performed in this study by simple randomization. To assign individuals to each drug and drug group, participants who have signed a consent form to participate in the study are asked to draw in one. Be divided into groups A and B, Blinding description: In order to inform the participants, researcher and analyst, the pharmaceutical manufacturer (Barij Essen) will receive information about the shape, size and color of the capsule and will be asked from the placebo company (Zahrawi) to make placebo capsules in accordance with the characteristics Drug should be provided. Then, the person who is not involved in the research is asked to pack the capsules in two different types, identifying each category with letters A and B. After completing the sampling and doing the analysis, the person is asked to specify the type of each categories.</study_design>
      <phase>3</phase>
      <hc_freetext>Blood sugar and lipids in  pre-diabetic menopausal women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After measuring the levels of FBS, HbA1C, HDL, LDL, TG and cholesterol, the participants consumed 2 of Evening Primrose capsules for 3 months ( At night and in the morning a capsule).After 3 months of intake, blood sugar and lipids are measured again. Intervention 2: Control group: After measuring the levels of FBS, HbA1C, HDL, LDL, TG and cholesterol, the participants consumed 2 of placebo capsules for 3 months ( At night and in the morning a capsule).After 3 months of intake, blood sugar and lipids are measured 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asma Absalan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Ave, Motaahhari Blvd Faculty of Nursing,Midwifery,Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>asma.absalan.a@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyedeh MarymLotfipour Rafsanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Ave, Motaahhari Blvd Faculty of Nursing,Midwifery,Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>maryam_lotfypur@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>written consent of the company in the study
Pre-diabetic women (fasting blood glucose 125-100 mg / dl)
Non-use of alcohol, tobacco and narcotics
. Lack of HRT at present
Non-use of supplementary extract of Maghrib flower
Women who have been at least 12 months since their last menstruation
Lack of chronic mental illness
No use of blood glucose suppressants</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Need to use insulin
No proper use of the capsule
Sensitization to the capsule
Mistake in the dosage of medication for 2 consecutive days
Unwillingness to continue participating in the study at any time of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</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: After measuring the levels of FBS, HbA1C, HDL, LDL, TG and cholesterol, the participants consumed 2 of Evening Primrose capsules for 3 months ( At night and in the morning a capsule).After 3 months of intake, blood sugar and lipids are measured again.</i_keyword>
      <i_keyword>Control group: After measuring the levels of FBS, HbA1C, HDL, LDL, TG and cholesterol, the participants consumed 2 of placebo capsules for 3 months ( At night and in the morning a capsule).After 3 months of intake, blood sugar and lipids are measured again</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with abnormal HDL. Timepoint: Measurement of  before intervention and 3 months after intervention. Method of measurement: Laboratory values.</prim_outcome>
      <prim_outcome>Percentage of people with abnormal LDL. Timepoint: Measurement of  before intervention and 3 months after intervention. Method of measurement: Laboratory values.</prim_outcome>
      <prim_outcome>Percentage of people with abnormal TG. Timepoint: Measurement of  before intervention and 3 months after intervention. Method of measurement: Laboratory values.</prim_outcome>
      <prim_outcome>Percentage of people with abnormal Cholesterol. Timepoint: Measurement of  before intervention and 3 months after intervention. Method of measurement: Laboratory values.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>FBS levels. Timepoint: 3 month after intervention. Method of measurement: Laboratory values.</sec_outcome>
      <sec_outcome>HDL  levels. Timepoint: 3 month after intervention. Method of measurement: Laboratory values.</sec_outcome>
      <sec_outcome>LDL levels. Timepoint: 3 month after intervention. Method of measurement: Laboratory values.</sec_outcome>
      <sec_outcome>TG levels. Timepoint: 3 month after intervention. Method of measurement: Laboratory values.</sec_outcome>
      <sec_outcome>Cholesterol levels. Timepoint: 3 month after intervention. Method of measurement: Laboratory values.</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>Vice chancellor for research, Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Nursing avenue, Rafsanjan University of Medical Sciences rafsangan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
