Vascular Effect of CIMICIFUGA RACEMOSA

Postmenopausal Symptoms Clinical Trial

— CRDILA  

Official title:

Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786809
• Other study ID #: ETIC - CR-0417.0.203.000-09
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmenopausal Symptoms

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of symptoms and side effects	Patients symptoms before and after the use of Cimifuga Racemosa	28 days