Skip to main content
OpenTrials
Completed

NCT Number: NCT00794690

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menopause

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept. Obstetrics and Gynecology, Assiut University

Asyut, Asyut Governorate, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cimicifuga racemosa extract for the group

Drug

40 mg of Cimicifuga racemosa extract daily dor 12 months

Other names: Klimadynon®

Primary outcomes

  1. Effect on hepatic perfusion and liver functions

    Time frame: 12 months

Secondary outcomes

  1. Efficacy and tolerability

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: CR-LIVER

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Nov 20, 2008
Registry last updated
Aug 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.