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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Navamindradhiraj University
Sponsor:
Information provided by (Responsible Party):
Patsama Vichinsartvichai, Navamindradhiraj University
ClinicalTrials.gov Identifier:
NCT02093650
First received: March 19, 2014
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Kupperman index questionnaire at baseline, 4, 8 and 12 weeks


Secondary Outcome Measures:
  • A change in MENQOL [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily hot flushes frequency over 12 weeks treatment

  • Global satisfaction [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Overall patient satisfaction 0 - 10 scale

  • A change in liver function test [ Time Frame: baseline and week 12 ] [ Designated as safety issue: Yes ]
    Changes in liver function test from baseline and 12 weeks

  • adverse events [ Time Frame: week 4, week 8 and week 12 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Patsama Vichinsartvichai, MD., Navamindradhiraj University
ClinicalTrials.gov Identifier: NCT02093650     History of Changes
Other Study ID Numbers: 081/56, TCTR20140318001
Study First Received: March 19, 2014
Last Updated: September 23, 2014
Health Authority: Thailand: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014