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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Menopause

Intervention / Treatment
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* Drug: Cimicifuga racemosa extract for the group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: black cohosh extract, liver<br>100 postmenopausal women | Drug: Cimicifuga racemosa extract for the group<br>* 40 mg of Cimicifuga racemosa extract daily dor 12 months<br>* Other names: Klimadynon®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on hepatic perfusion and liver functions |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and tolerability |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cimicifuga racemosa, liver blood flow and functions