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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00010712 |
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 | Intervention | Phase |
---|---|---|
Postmenopause Hot Flashes Osteoporosis, Postmenopausal |
Drug: Black Cohosh |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Effects of Black Cohosh on Menopausal Hot Flashes |
Study Start Date: | September 1999 |
Estimated Study Completion Date: | July 2005 |
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.
Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, New York | |
Columbia University Rosenthal Center for CAM | |
New York, New York, United States, 10032 |
Principal Investigator: | Dr. Fredi Kronenberg | Columbia University |
Study ID Numbers: | P50 AT000090-01P3, P50 AT000090-01 |
Study First Received: | February 2, 2001 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00010712 |
Health Authority: | United States: Federal Government |
Menopause Hot Flashes Osteoporosis Postmenopausal |
Signs and Symptoms Musculoskeletal Diseases Hot Flashes Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Menopause |