Status:
UNKNOWN
Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women
Lead Sponsor:
Mahidol University
Conditions:
Hot Flashes
Eligibility:
FEMALE
40+ years
Phase:
PHASE3
Brief Summary
Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal sy...
Eligibility Criteria
Inclusion
- Thai women, aged ≥ 40 years
- Peri- or postmenopause
- Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
Exclusion
- Using any drugs or hormonal treatment within 1 month before enrollment
- BMI ≥ 30 kg/m2
- Allergic to drugs or any ingredient
- Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
- Psychiatric disease
- Alcohol consumption or any elicit drug use
- Vegetarian (may consume more phytoestrogen)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01487694
Start Date
December 1 2011
End Date
October 1 2012
Last Update
December 29 2011
Active Locations (1)
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1
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700