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

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ClinicalTrials.gov Identifier: NCT02093650
Recruitment Status : Unknown
Verified September 2014 by Patsama Vichinsartvichai, Navamindradhiraj University.
Recruitment status was:  Recruiting
First Posted : March 21, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Patsama Vichinsartvichai, Navamindradhiraj University

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

Condition or disease Intervention/treatment Phase
Menopause Quality of Life Drug: black cohosh extract Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : March 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. A change in MENQOL [ Time Frame: baseline and week 12 ]
    MENQOL questionnaire measurement at baseline and 12 weeks

  2. 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

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

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

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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093650


Contacts
Contact: Patsama Vichinsartvichai, MD. +66877905656 pat_si109@hotmail.com
Contact: Lookwai Kutheerawong, MD. +66820886464 lookwaik@yahoo.com

Locations
Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University Recruiting
Dusit, Bangkok, Thailand, 10300
Contact: Patsama Vichinsartvichai, MD    +66877905656    pat_si109@hotmail.com   
Principal Investigator: Patsama Vichinsartvichai, MD         
Sub-Investigator: Lookwai Kutheerawong, MD         
Sponsors and Collaborators
Navamindradhiraj University
Investigators
Principal Investigator: Patsama Vichinsartvichai, MD Faculty of Medicine Vajira Hospital

Responsible Party: Patsama Vichinsartvichai, MD., Navamindradhiraj University
ClinicalTrials.gov Identifier: NCT02093650     History of Changes
Other Study ID Numbers: 081/56
TCTR20140318001 ( Registry Identifier: Thai Clinical Trials Registry )
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Patsama Vichinsartvichai, Navamindradhiraj University:
Menopausal symptoms
menopause related quality of life
black cohosh
cimicifuga racemosa
MENQOL
Kupperman index
KI
liver function tests