Overview

Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women

Status:
Unknown status
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
Female
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 symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mahidol University
Criteria
Inclusion Criteria:

- Thai women, aged ≥ 40 years

- Peri- or postmenopause

- Moderate to severe menopausal symptoms from Kupperman menopausal index score at least
20

Exclusion Criteria:

- 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)