Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver

Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00794690

Acronym

CR-LIVER

Enrollment

100

Registered

2008-11-20

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2009-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

cimicifuga racemosa, liver blood flow and functions

Brief summary

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.

Detailed description

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.

Interventions

DRUGCimicifuga racemosa extract for the group

40 mg of Cimicifuga racemosa extract daily dor 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* an age over 40 years * with a lapse of one year after the last menstruation * symptomatic women without gynecological illness * after naturally occurring menopause * had never used hormonal therapy or had stopped using them for \>6 months * accepting to participate after receiving adequate description of the study * accessible for regular follow-up.

Exclusion criteria

* vaginal bleeding * active or chronic liver disease and /or abnormal liver functions * present or past thromboembolic disease * present or past neoplasia of the breast or uterus * an endometrial thickness \>5 mm by TVS * use of alternative or complementary medicines or herbs for menopausal symptoms within the previous three months

Design outcomes

Primary

Measure	Time frame
Effect on hepatic perfusion and liver functions	12 months

Secondary

Measure	Time frame
Efficacy and tolerability	12 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026