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

Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01487694

Enrollment

Registered

2011-12-07

Start date

2011-12-31

Completion date

2012-10-31

Last updated

2011-12-29

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

Conditions

Hot Flashes

Keywords

back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL

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 symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.

Interventions

DRUGcimicifuga racemosa

Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)

DRUGplacebo

matching placebo without active ingredient 1 tab daily for 12 weeks

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

* 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)

Design outcomes

Primary

Measure	Time frame
Mean differences of Kupperman index	12 weeks

Secondary

Measure	Time frame	Description
Compliance	12 weeks	—
adverse events	12 weeks	—
Frequencies of menopausal symptoms	12 weeks	—
quality of life	12 weeks	Thai MENQOL measurement
Overall satisfaction	12 weeks	—
Mean differences of liver function test	12 weeks	—

Countries

Thailand

Contacts

Primary ContactPatsama Vichinsartvichai, MD

pat_si109@hotmail.com664194657-8

Outcome results

None listed

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