Menopause Clinical Trial
Official title:
Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.
The aim of this prospective longitudinal clinical trial is to evaluate changes in total
hepatic blood flow and liver functions among postmenopausal women using black cohosh
(cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor
symptoms.
Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa
(Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color
Doppler ultrasound. Moreover, prothrombin time & concentration, serum albumin, bilirubin,
gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) will also be measured.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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