NCT02093650

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

March 19, 2014

Last Update Submit

September 23, 2014

Conditions

MenopauseQuality of Life

Keywords

Menopausal symptomsmenopause related quality of lifeblack cohoshcimicifuga racemosaMENQOLKupperman indexKIliver function tests

Outcome Measures

Primary Outcomes (1)

  • The changes in Kupperman Index

    Kupperman index questionnaire at baseline, 4, 8 and 12 weeks

    baseline, week 4, week 8 and week 12

Secondary Outcomes (5)

  • A change in MENQOL

    baseline and week 12

  • The changes in daily hot flushes frequency

    baseline, week 4, week 8 and week 12

  • Global satisfaction

    week 12

  • A change in liver function test

    baseline and week 12

  • adverse events

    week 4, week 8 and week 12

Study Arms (2)

Black cohosh extract

ACTIVE COMPARATOR

black cohosh extract 80 mg daily

Drug: black cohosh extract

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

black cohosh extractDRUG

Black cohosh extract 80 mg

Also known as: Femosa
Black cohosh extract
PlaceboDRUG

Soy bean oil

Placebo

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 40 years
  • Peri or post menopause
  • Moderate to severe menopausal symptoms (Kupperman index at least 20)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

RECRUITING

MeSH Terms

Interventions

black cohosh root extract

Study Officials

  • Patsama Vichinsartvichai, MD

    Faculty of Medicine Vajira Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patsama Vichinsartvichai, MD.

CONTACT

+66877905656pat_si109@hotmail.com

Lookwai Kutheerawong, MD.

CONTACT

+66820886464lookwaik@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

TH(1)