Status:
COMPLETED
Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver
Lead Sponsor:
Assiut University
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 po...
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) extra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00794690
Start Date
January 1 2008
End Date
January 1 2009
Last Update
August 3 2009
Active Locations (1)
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1
Dept. Obstetrics and Gynecology, Assiut University
Asyut, Asyut Governorate, Egypt, 71516