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Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women

This study is currently recruiting participants.
Verified December 2011 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01487694
First received: December 5, 2011
Last updated: December 24, 2011
Last verified: December 2011
History of Changes
  Purpose

Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.


Condition Intervention Phase
Hot Flashes
 Drug: cimicifuga racemosa
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Menopause
Drug Information available for: Cimicifuga
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Mean differences of Kupperman index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequencies of menopausal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mean differences of liver function test [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Thai MENQOL measurement

  • Overall satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cimicifuga racemosa
patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)
 Drug: cimicifuga racemosa
Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)
Placebo Comparator: Placebo
Placebo containing no active ingredient which match the drug in bottle, shape, color and smell
 Drug: placebo
matching placebo without active ingredient 1 tab daily for 12 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Thai women, aged ≥ 40 years
  • Peri- or postmenopause
  • Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20

Exclusion Criteria:

  • Using any drugs or hormonal treatment within 1 month before enrollment
  • BMI ≥ 30 kg/m2
  • Allergic to drugs or any ingredient
  • Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
  • Psychiatric disease
  • Alcohol consumption or any elicit drug use
  • Vegetarian (may consume more phytoestrogen)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487694

Contacts
Contact: Patsama Vichinsartvichai, MD 664194657-8 pat_si109@hotmail.com

Locations
Thailand
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Sub-Investigator: Prasong Tanmahasamut, MD            
Principal Investigator: Patsama Vichinsartvichai, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Patsama Vichinsartvichai, MD Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01487694     History of Changes
Other Study ID Numbers: Si573/2011
Study First Received: December 5, 2011
Last Updated: December 24, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
back cohosh
cimicifuga racemosa
menopausal symptoms
 hot flashes
Kupperman index
MENQOL

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013