Black cohosh extract for the treatment of moderate to severe menopausal symptoms: a randomized placebo controlled trial

Phase 3

Recruiting

• Conditions: Menopausal symptomsMenopause related quality of lifeNumber of hot flushes per dayGlobal patient satisfactionAdverse eventLiver function test changes; black cohosh; menopausal symptoms; hot flushes; MENQOL; Kupperman index; Liver function; satisfaction

• Registration Number: TCTR20140318001
• Lead Sponsor: Cerebos Research Award 2013

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-18
• Study Completion: 2015-03-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Age at least 40 years
Peri- or post menopause
Moderate to severe menopausal symptoms (KI 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: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Kupperman Index 12 weeks Score

Secondary Outcome Measures

Name	Time	Method
Menopause specific quality of lilfe 12 weeks Score,Daily hot flushes frequency 12 weeks times,Liver function test 12 weeks Serum measurement,Global satisfaction 12 weeks score,Adverse events 12 weeks events