Vascular Effect of CIMICIFUGA RACEMOSA

Overview

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.

Full Title of Study: “Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2019

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.

Interventions

  • Drug: Cimifuga Racemosa
    • Experimental group will use 160mg of Cimifuga Racemosa for 28 days
  • Drug: Placebo
    • patients of the placebo group will use placebo once a day for 28 days

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Frequency of symptoms and side effects
    • Time Frame: 28 days
    • Patients symptoms before and after the use of Cimifuga Racemosa

Participating in This Clinical Trial

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

Gender Eligibility: Female

only postmenopausal women will be included

Minimum Age: 45 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Selmo Geber, Professor – Federal University of Minas Gerais
  • Overall Official(s)
    • Selmo Geber, MD PhD, Principal Investigator, Universidde Federal de Minas Gerais

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