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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Navamindradhiraj University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Patsama Vichinsartvichai, Navamindradhiraj University Identifier:
First received: March 19, 2014
Last updated: September 23, 2014
Last verified: September 2014
Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

Condition Intervention Phase
Quality of Life
Drug: black cohosh extract
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by Navamindradhiraj University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • A change in MENQOL [ Time Frame: baseline and week 12 ]
    MENQOL questionnaire measurement at baseline and 12 weeks

  • 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

  • Global satisfaction [ Time Frame: week 12 ]
    Overall patient satisfaction 0 - 10 scale

  • A change in liver function test [ Time Frame: baseline and week 12 ]
    Changes in liver function test from baseline and 12 weeks

  • adverse events [ Time Frame: week 4, week 8 and week 12 ]
    frequency of adverse events

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Black cohosh extract
black cohosh extract 80 mg daily
Drug: black cohosh extract
Black cohosh extract 80 mg
Other Name: Femosa
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Soy bean oil

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02093650

Contact: Patsama Vichinsartvichai, MD. +66877905656
Contact: Lookwai Kutheerawong, MD. +66820886464

Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University Recruiting
Dusit, Bangkok, Thailand, 10300
Contact: Patsama Vichinsartvichai, MD    +66877905656   
Principal Investigator: Patsama Vichinsartvichai, MD         
Sub-Investigator: Lookwai Kutheerawong, MD         
Sponsors and Collaborators
Navamindradhiraj University
Principal Investigator: Patsama Vichinsartvichai, MD Faculty of Medicine Vajira Hospital
  More Information

Responsible Party: Patsama Vichinsartvichai, MD., Navamindradhiraj University Identifier: NCT02093650     History of Changes
Other Study ID Numbers: 081/56
TCTR20140318001 ( Registry Identifier: Thai Clinical Trials Registry )
Study First Received: March 19, 2014
Last Updated: September 23, 2014

Keywords provided by Navamindradhiraj University:
Menopausal symptoms
menopause related quality of life
black cohosh
cimicifuga racemosa
Kupperman index
liver function tests processed this record on May 23, 2017