Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver (CR-LIVER)

July 31, 2009 updated by: Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71516
        • Dept. Obstetrics and Gynecology, Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Klimadynon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on hepatic perfusion and liver functions
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy and tolerability
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: AHMED M NASR, MD, Assiut university, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR and the liver

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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