Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms (BCOMS)

Navamindradhiraj University

Status and phase: Unknown; Phase 3

Conditions: Quality of Life; Menopause

Treatments: Drug: black cohosh extract; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02093650

081/56

TCTR20140318001 (Registry Identifier)

Details and patient eligibility

About

Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

Full description

Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL

Enrollment: 60 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age at least 40 years
• Peri or post menopause
• Moderate to severe menopausal symptoms (Kupperman index at least 20)

Exclusion criteria

• Use hormonal treatment or other treatments within 4 weeks
• Use atorvastatin azathioprine or cyclosporin within 4 weeks
• BMI at least 30 kg m2
• Allergic to drug or components
• Liver disease or abnormal liver function test
• Psychiatric disease
• Alcoholic or drug abuse
• Vegetarian

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Black cohosh extract

Active Comparator group

Description:

black cohosh extract 80 mg daily

Treatment:

Drug: black cohosh extract

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo