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Vascular Effect of CIMICIFUGA RACEMOSA (CRDILA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786809
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Symptoms Drug: Cimifuga Racemosa Drug: Placebo Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : May 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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
 Drug: Cimifuga Racemosa
Experimental group will use 160mg of Cimifuga Racemosa for 28 days
Other Names:
  • Clifemin
  • Acteia
Placebo Comparator: Placebo
Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment
 Drug: Placebo
patients of the placebo group will use placebo once a day for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. Frequency of symptoms and side effects [ Time Frame: 28 days ]
    Patients symptoms before and after the use of Cimifuga Racemosa


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only postmenopausal women will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with postmenopausal vascular symptoms
  • Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH) > 30 International Units(IU)/Litre
  • Women that were not using drugs with potential vascular effect within the last 1 year
  • Women that were not using hormone replacement therapy within the last 1 year

Exclusion Criteria:

  • Smoking
  • Blood Pressure > 160/90 mm Hg.
  • Breast and or endometrial cancer
  • History of acute myocardial infarction
  • Diabetes
  • Vaginal bleeding of any origin
  • Hepatic disease
  • Thrombophlebitis or thromboembolic disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786809


Locations
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Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Selmo Geber, MD PhD Universidde Federal de Minas Gerais
More Information
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Responsible Party: Selmo Geber, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03786809    
Other Study ID Numbers: ETIC - CR-0417.0.203.000-09
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selmo Geber, Federal University of Minas Gerais:
postmenopause
vascular effects
CIMICIFUGA RACEMOSA