Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver (CR-LIVER)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions|
- Effect on hepatic perfusion and liver functions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Efficacy and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: black cohosh extract, liver
100 postmenopausal women
Drug: Cimicifuga racemosa extract for the group
40 mg of Cimicifuga racemosa extract daily dor 12 months
Other Name: Klimadynon®
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.