Vascular Effect of CIMICIFUGA RACEMOSA

NCT ID: NCT03786809

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postmenopausal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Cimifuga Racemosa

Intervention Type DRUG

Experimental group will use 160mg of Cimifuga Racemosa for 28 days

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patients of the placebo group will use placebo once a day for 28 days

Interventions

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Cimifuga Racemosa

Experimental group will use 160mg of Cimifuga Racemosa for 28 days

Intervention Type DRUG

Placebo

patients of the placebo group will use placebo once a day for 28 days

Intervention Type DRUG

Other Intervention Names

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Clifemin Acteia

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Selmo Geber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selmo Geber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidde Federal de Minas Gerais

Locations

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Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ETIC - CR-0417.0.203.000-09

Identifier Type: -

Identifier Source: org_study_id

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