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

Assiut University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Menopause

Interventions

Cimicifuga racemosa extract for the groupDRUG

40 mg of Cimicifuga racemosa extract daily dor 12 months

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept. Obstetrics and Gynecology, Assiut University

Asyut, Asyut Governorate, Egypt

Outcomes

Primary Outcomes

Effect on hepatic perfusion and liver functions

Time frame: 12 months

Secondary Outcomes

Efficacy and tolerability

Time frame: 12 months

Data from ClinicalTrials.gov

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