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Effects of Black Cohosh on Menopausal Hot Flashes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00010712
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Condition or disease Intervention/treatment Phase
Postmenopause Hot Flashes Osteoporosis, Postmenopausal Drug: Black Cohosh Phase 2

Detailed Description:

Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT.

For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms.

Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Effects of Black Cohosh on Menopausal Hot Flashes
Study Start Date : September 1999
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident of the New York Metro Area
  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight
Contacts and Locations
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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): NCT00010712


Locations
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United States, New York
Columbia University Rosenthal Center for CAM
New York, New York, United States, 10032
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Dr. Fredi Kronenberg Columbia University
More Information
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ClinicalTrials.gov Identifier: NCT00010712    
Obsolete Identifiers: NCT00009386
Other Study ID Numbers: P50AT000090-01P3 ( U.S. NIH Grant/Contract )
P50AT000090-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Menopause
Hot Flashes
Osteoporosis
Postmenopausal
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Hot Flashes
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases