<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786809</url>
  </required_header>
  <id_info>
    <org_study_id>ETIC - CR-0417.0.203.000-09</org_study_id>
    <nct_id>NCT03786809</nct_id>
  </id_info>
  <brief_title>Vascular Effect of CIMICIFUGA RACEMOSA</brief_title>
  <acronym>CRDILA</acronym>
  <official_title>Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the&#xD;
      effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The interruption of the secretion of ovarian steroids after menopause, determines a change in&#xD;
      the vascular pattern in several levels. Thus, several vascular effects might interfere with&#xD;
      women's health. The use of hormone replacement therapy has contributed to the improvement in&#xD;
      these effects. In previous studies, the investigators observed the effects of hormonal&#xD;
      replacement therapy in improving such effects in postmenopausal women. The aim of the present&#xD;
      study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of&#xD;
      the brachial artery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa</measure>
    <time_frame>28 days</time_frame>
    <description>We will evaluate the vascular effect of Cimifuga Racemosa on the brachial artery. The diameter of the artery will be measured before and one month after use of Cimifuga Racemosa and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of symptoms and side effects</measure>
    <time_frame>28 days</time_frame>
    <description>Patients symptoms before and after the use of Cimifuga Racemosa</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postmenopausal Symptoms</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will use Cimifuga Racemosa for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cimifuga Racemosa</intervention_name>
    <description>Experimental group will use 160mg of Cimifuga Racemosa for 28 days</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Clifemin</other_name>
    <other_name>Acteia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>patients of the placebo group will use placebo once a day for 28 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with postmenopausal vascular symptoms&#xD;
&#xD;
          -  Women without menstrual cycles within the last 12 months and follicle stimulating&#xD;
             hormone (FSH) &gt; 30 International Units(IU)/Litre&#xD;
&#xD;
          -  Women that were not using drugs with potential vascular effect within the last 1 year&#xD;
&#xD;
          -  Women that were not using hormone replacement therapy within the last 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Blood Pressure &gt; 160/90 mm Hg.&#xD;
&#xD;
          -  Breast and or endometrial cancer&#xD;
&#xD;
          -  History of acute myocardial infarction&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Vaginal bleeding of any origin&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  Thrombophlebitis or thromboembolic disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only postmenopausal women will be included</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Selmo Geber, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidde Federal de Minas Gerais</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clinicas - Universidade Federal de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Selmo Geber</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>postmenopause</keyword>
  <keyword>vascular effects</keyword>
  <keyword>CIMICIFUGA RACEMOSA</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786809
org study id: ETIC - CR-0417.0.203.000-09
nct id: NCT03786809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the
      effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.
The interruption of the secretion of ovarian steroids after menopause, determines a change in
      the vascular pattern in several levels. Thus, several vascular effects might interfere with
      women's health. The use of hormone replacement therapy has contributed to the improvement in
      these effects. In previous studies, the investigators observed the effects of hormonal
      replacement therapy in improving such effects in postmenopausal women. The aim of the present
      study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of
      the brachial artery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa
time frame: 28 days
description: We will evaluate the vascular effect of Cimifuga Racemosa on the brachial artery. The diameter of the artery will be measured before and one month after use of Cimifuga Racemosa and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.
measure: Frequency of symptoms and side effects
time frame: 28 days
description: Patients symptoms before and after the use of Cimifuga Racemosa
arm group label: Experimental
arm group type: Experimental
description: Women will use Cimifuga Racemosa for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment
arm group label: Placebo
arm group type: Placebo Comparator
description: Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment
intervention type: Drug
intervention name: Cimifuga Racemosa
description: Experimental group will use 160mg of Cimifuga Racemosa for 28 days
arm group label: Experimental
other name: Clifemin
other name: Acteia
intervention type: Drug
intervention name: Placebo
description: patients of the placebo group will use placebo once a day for 28 days
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: only postmenopausal women will be included
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Selmo Geber, MD PhD
role: Principal Investigator
affiliation: Universidde Federal de Minas Gerais
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Selmo Geber
investigator title: Professor