Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms (BCOMS)

September 23, 2014 updated by: Patsama Vichinsartvichai, Navamindradhiraj University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Recruiting
        • Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
        • Contact:
        • Sub-Investigator:
          • Lookwai Kutheerawong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Soy bean oil
Active Comparator: Black cohosh extract
black cohosh extract 80 mg daily
Drug: black cohosh extract
Black cohosh extract 80 mg
Other Names:
  • Femosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in Kupperman Index
Time Frame: baseline, week 4, week 8 and week 12
Kupperman index questionnaire at baseline, 4, 8 and 12 weeks
baseline, week 4, week 8 and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in MENQOL
Time Frame: baseline and week 12
MENQOL questionnaire measurement at baseline and 12 weeks
baseline and week 12
The changes in daily hot flushes frequency
Time Frame: baseline, week 4, week 8 and week 12
Daily hot flushes frequency over 12 weeks treatment
baseline, week 4, week 8 and week 12
Global satisfaction
Time Frame: week 12
Overall patient satisfaction 0 - 10 scale
week 12
A change in liver function test
Time Frame: baseline and week 12
Changes in liver function test from baseline and 12 weeks
baseline and week 12
adverse events
Time Frame: week 4, week 8 and week 12
frequency of adverse events
week 4, week 8 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navamindradhiraj University

Investigators

  • Principal Investigator: Patsama Vichinsartvichai, MD, Faculty of Medicine Vajira Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 081/56
  • TCTR20140318001 (Registry Identifier: Thai Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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