Postmenopausal Symptoms
Conditions
Keywords
postmenopause, vascular effects, CIMICIFUGA RACEMOSA
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.
Interventions
DRUGCimifuga Racemosa
Experimental group will use 160mg of Cimifuga Racemosa for 28 days
DRUGPlacebo
patients of the placebo group will use placebo once a day for 28 days
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of symptoms and side effects | 28 days | Patients symptoms before and after the use of Cimifuga Racemosa |
Countries
Brazil
Outcome results
None listed