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

Menopause Clinical Trial

— CR-LIVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794690
• Other study ID #: CR and the liver
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: July 31, 2009
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2009
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Cimicifuga racemosa extract for the group
40 mg of Cimicifuga racemosa extract daily dor 12 months

Locations

Country	Name	City	State
Egypt	Dept. Obstetrics and Gynecology, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Chow EC, Teo M, Ring JA, Chen JW. Liver failure associated with the use of black cohosh for menopausal symptoms. Med J Aust. 2008 Apr 7;188(7):420-2. — View Citation

Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, Marles RJ, Pellicore LS, Giancaspro GI, Sarma DN. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause. 2008 Jul-Aug;15(4 Pt 1):628-38. doi: 10.1097/gme.0b013e31816054bf. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on hepatic perfusion and liver functions		12 months	Yes
Secondary	Efficacy and tolerability		12 months	No