Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093650

Acronym

BCOMS

Enrollment

Registered

2014-03-21

Start date

2014-03-31

Completion date

2016-07-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Quality of Life

Keywords

Menopausal symptoms, menopause related quality of life, black cohosh, cimicifuga racemosa, MENQOL, Kupperman index, KI, liver function tests

Brief summary

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

Detailed 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

Interventions

DRUGblack cohosh extract

Black cohosh extract 80 mg

DRUGPlacebo

Soy bean oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The changes in Kupperman Index	baseline, week 4, week 8 and week 12	Kupperman index questionnaire at baseline, 4, 8 and 12 weeks

Secondary

Measure	Time frame	Description
A change in MENQOL	baseline and week 12	MENQOL questionnaire measurement at baseline and 12 weeks
The changes in daily hot flushes frequency	baseline, week 4, week 8 and week 12	Daily hot flushes frequency over 12 weeks treatment
Global satisfaction	week 12	Overall patient satisfaction 0 - 10 scale
A change in liver function test	baseline and week 12	Changes in liver function test from baseline and 12 weeks
adverse events	week 4, week 8 and week 12	frequency of adverse events

Countries

Thailand

Contacts

Primary ContactPatsama Vichinsartvichai, MD.

pat_si109@hotmail.com+66877905656

Backup ContactLookwai Kutheerawong, MD.

lookwaik@yahoo.com+66820886464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026