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

Not Applicable

Completed

• Conditions: Menopause
• Interventions: Drug: Cimicifuga racemosa extract for the group

• Registration Number: NCT00794690
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
black cohosh extract, liver	Cimicifuga racemosa extract for the group	100 postmenopausal women

Primary Outcome Measures

Name	Time	Method
Effect on hepatic perfusion and liver functions	12 months

Secondary Outcome Measures

Name	Time	Method
Efficacy and tolerability	12 months

Trial Locations

Locations (1)

Dept. Obstetrics and Gynecology, Assiut University; 🇪🇬 Assiut, Egypt