Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

Quality of Life Clinical Trial

— BCOMS  

Official title:

Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02093650
• Other study ID #: 081/56
• Secondary ID: TCTR20140318001
• Status: Recruiting
• Phase: Phase 3
• First received: March 19, 2014
• Last updated: September 23, 2014
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2014
• Source: Navamindradhiraj University
• Contact: Patsama Vichinsartvichai, MD.
• Phone: +66877905656
• Email: pat_si109[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause
• Quality of Life

Intervention

Drug:
• black cohosh extract
Black cohosh extract 80 mg
• Placebo
Soy bean oil

Locations

Country	Name	City	State
Thailand	Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in Kupperman Index	Kupperman index questionnaire at baseline, 4, 8 and 12 weeks	baseline, week 4, week 8 and week 12	No
Secondary	A change in MENQOL	MENQOL questionnaire measurement at baseline and 12 weeks	baseline and week 12	No
Secondary	The changes in daily hot flushes frequency	Daily hot flushes frequency over 12 weeks treatment	baseline, week 4, week 8 and week 12	No
Secondary	Global satisfaction	Overall patient satisfaction 0 - 10 scale	week 12	No
Secondary	A change in liver function test	Changes in liver function test from baseline and 12 weeks	baseline and week 12	Yes
Secondary	adverse events	frequency of adverse events	week 4, week 8 and week 12	Yes