Vascular Effect of CIMICIFUGA RACEMOSA

Not Applicable

Completed

• Conditions: Postmenopausal Symptoms
• Interventions: Drug: Cimifuga Racemosa; Drug: Placebo

• Registration Number: NCT03786809
• Lead Sponsor: Federal University of Minas Gerais

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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Primary Completion: 2019-04
• Study Completion: 2019-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Cimifuga Racemosa	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	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

Primary Outcome Measures

Name	Time	Method
Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa	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

Name	Time	Method
Frequency of symptoms and side effects	28 days	Patients symptoms before and after the use of Cimifuga Racemosa

Trial Locations

Locations (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil