Vascular Effect of CIMICIFUGA RACEMOSA (CRDILA)

Federal University of Minas Gerais

Status: Completed

Conditions: Postmenopausal Symptoms

Treatments: Drug: Placebo; Drug: Cimifuga Racemosa

Study type: Interventional

Funder types: Other

Identifiers

NCT03786809

ETIC - CR-0417.0.203.000-09

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Drug: Cimifuga Racemosa

Placebo

Placebo Comparator group

Description:

Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment

Treatment:

Drug: Placebo