Vascular Effect of CIMICIFUGA RACEMOSA

NCT03786809 | Completed

• 1 other identifier: ETIC - CR-0417.0.203.000-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Symptoms

Keywords

postmenopause; vascular effects; CIMICIFUGA RACEMOSA

Outcome Measures

Primary Outcomes (1)

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

  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.

  28 days

Secondary Outcomes (1)

• Frequency of symptoms and side effects

  28 days

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Cimifuga Racemosa DRUG

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

Also known as: Clifemin, Acteia

Experimental

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: only postmenopausal women will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

Study Officials

• Selmo Geber, MD PhD

  Universidde Federal de Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: June 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

BR (1)