Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

Phase 3

• Conditions: Menopause; Quality of Life
• Interventions: Drug: black cohosh extract; Drug: Placebo

• Registration Number: NCT02093650
• Lead Sponsor: Navamindradhiraj University

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-21
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25
• Primary Completion: 2016-03
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Black cohosh extract	black cohosh extract	black cohosh extract 80 mg daily
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
The changes in Kupperman Index	baseline, week 4, week 8 and week 12	Kupperman index questionnaire at baseline, 4, 8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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
adverse events	week 4, week 8 and week 12	frequency of adverse events
A change in liver function test	baseline and week 12	Changes in liver function test from baseline and 12 weeks

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University; 🇹🇭 Dusit, Bangkok, Thailand