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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00794690
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : August 3, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Menopause Drug: Cimicifuga racemosa extract for the group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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 Name: Klimadynon®

Primary Outcome Measures :
  1. Effect on hepatic perfusion and liver functions [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Efficacy and tolerability [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00794690

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Dept. Obstetrics and Gynecology, Assiut University
Assiut, Egypt, 71516
Sponsors and Collaborators
Assiut University
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Responsible Party: Prof. Ezat Hamed Sayed, Department of Obstetrics & Gynecology Identifier: NCT00794690     History of Changes
Other Study ID Numbers: CR and the liver
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009
Keywords provided by Assiut University:
cimicifuga racemosa
liver blood flow and functions