Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010712
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Effects of Black Cohosh on Menopausal Hot Flashes
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effects of Black Cohosh on Menopausal Hot Flashes
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 womens 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
For centuries black cohosh Cimicifuga racemosa has been used worldwide for womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT000090-01 | NIH | None | httpsreporternihgovquickSearchP50AT000090-01 |