Clinical trial NCT00794690: Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver
Official title: Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: cimicifuga racemosa
liver blood flow and functions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2008-11-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Effect on hepatic perfusion and liver functions
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy and tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Dept. Obstetrics and Gynecology, Assiut University
Study officials:
affiliation: ASSIUT UNIVERSITY, EGYPT
name: AHMED M NASR, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.5694/j.1326-5377.2008.tb01691.x. No abstract available.