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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Hot Flashes

Treatments: Drug: placebo; Drug: cimicifuga racemosa

Study type: Interventional

Funder types: Other

Identifiers

NCT01487694

Si573/2011

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Cimicifuga racemosa

Experimental group

Description:

patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)

Treatment:

Drug: cimicifuga racemosa

Placebo

Placebo Comparator group

Description:

Placebo containing no active ingredient which match the drug in bottle, shape, color and smell

Treatment:

Drug: placebo