Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver (CR-LIVER)
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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 |
- Effect on hepatic perfusion and liver functions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 23, 2013