Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Menopause Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Black cohosh extract

black cohosh extract 80 mg daily

Group Type ACTIVE_COMPARATOR

black cohosh extract

Intervention Type DRUG

Black cohosh extract 80 mg

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Soy bean oil

Interventions

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black cohosh extract

Black cohosh extract 80 mg

Intervention Type DRUG

Placebo

Soy bean oil

Intervention Type DRUG

Other Intervention Names

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Femosa

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes