<?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>IRCT20170227032795N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-26</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women refer to Kamali hospital in 1396</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple random sampling method was used to randomize distribution of subjects in two groups of intervention and control group.
The numbers 1 to 60 were written in the same color and shape paper. The paper was put in a pot after folding. Then the bowl components were stirred. By the person who did not have a role in this project, the paper was taken randomly. The first 30 numbers that came out of the bowl were intended for people who are supposed to be in the blue group.The 30 numbers remained in the bowl, the red group was considered, Blinding description: By the person who does not play a role in this project, the coordination of drug and placebo packaging is performed in two packages with different color schemes. Supervisors and project students, as well as those involved in clinical trials, are unaware of the nature of these packages until the end of the design and receiving the latest test results and analysis of the data.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Menopause.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Elaeagnus angustifolia L powder, 15 g / day longer 10 weeks. Intervention 2: Control group(placebo):7.5 g isomalt and 7.5 g corn starch longer 10 weeks.</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 We will not disclose the private information of the participants in the project.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Emami Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of Biology, University of Damghan, Damghan</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۱۶۷ - ۳۶۷۱۶</zip>
        <telephone>+98 22001395</telephone>
        <email>Farzaneh.Emaminia@gmail.com</email>
        <affiliation>University of Damghan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Arezoo Rezaei/Dr.Bita Badehnoosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of Biology, University of Damghan, Damghan Square ,Damghan / Alborz University of Medical Sciences, North Taleghani avenue, Taleghni Square , Karaj, Alborz</address>
        <city>Damghan/Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 912 332 5792</telephone>
        <email>arezaei@du.ac.ir</email>
        <affiliation>Damghan university/Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Postmenopausal women aged 40-70.
Serum lipid level of 200-300 mg / ml.
No risk factor for using the drug to lower this lipid level.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular diseases.
Renal diseases.
Metabolic disorders such as diabetes.
Those using psychiatric drugs.
Having destructive habits like cigarettes, hookahs, consuming alcohol and drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and perimenopausal disorder, unspecified.</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: Elaeagnus angustifolia L powder, 15 g / day longer 10 weeks.</i_keyword>
      <i_keyword>Control group(placebo):7.5 g isomalt and 7.5 g corn starch longer 10 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LDL. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Total Protein. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Estradiol. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Progesterone. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Testosterone. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>FSH (Follicle stimulating hormone). Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>LH (Luteinizing hormone). Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>DHEA-SO4. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>TSH. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Urinalysis and culture. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Heart beat. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Vitamin D3. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Pap smear. Timepoint: Before the start of the trial. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Prolactin. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Vaginal culture. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>Cortisol. Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
      <prim_outcome>FBS(Fasting blood sugar). Timepoint: Before the start of the trial and 10 weeks after taking the drug or placebo. Method of measurement: Standards of medical diagnostic laboratories.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Constipation, Abdominal Pain. Timepoint: End of the course after 10 weeks. Method of measurement: Standards of medical diagnostic laboratories.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Damghan university</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Karaj University of Medical Sciences</source_name>
      <source_name>Damghan university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-10</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, administrative city, north Taleghani avenue, Karaj, Alborz Alborz Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
