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

This study has been completed.
Sponsor:
Information provided by:
Assiut University
ClinicalTrials.gov Identifier:
NCT00794690
First received: November 19, 2008
Last updated: July 31, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Menopause
Drug: Cimicifuga racemosa extract for the group

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Effect on hepatic perfusion and liver functions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794690

Locations
Egypt
Dept. Obstetrics and Gynecology, Assiut University
Assiut, Egypt, 71516
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: AHMED M NASR, MD ASSIUT UNIVERSITY, EGYPT
  More Information

Publications:
Responsible Party: Prof. Ezat Hamed Sayed, Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT00794690     History of Changes
Other Study ID Numbers: CR and the liver
Study First Received: November 19, 2008
Last Updated: July 31, 2009
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Assiut University:
cimicifuga racemosa
liver blood flow and functions

ClinicalTrials.gov processed this record on September 30, 2014