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

Phase 3

• Conditions: Hot Flashes
• Interventions: Drug: placebo; Drug: cimicifuga racemosa

• Registration Number: NCT01487694
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Last Update Submitted: 2011-12-24
• Last Update Posted: 2011-12-29
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo containing no active ingredient which match the drug in bottle, shape, color and smell
Cimicifuga racemosa	cimicifuga racemosa	patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)

Primary Outcome Measures

Name	Time	Method
Mean differences of Kupperman index	12 weeks

Secondary Outcome Measures

Name	Time	Method
Frequencies of menopausal symptoms	12 weeks
Compliance	12 weeks
adverse events	12 weeks
Mean differences of liver function test	12 weeks
quality of life	12 weeks	Thai MENQOL measurement
Overall satisfaction	12 weeks

Trial Locations

Locations (1)

Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand