Effects of Black Cohosh on Menopausal Hot Flashes

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010712
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Effects of Black Cohosh on Menopausal Hot Flashes

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1999
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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
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: NCT00010712

Locations
United States, New York
Columbia University Rosenthal Center for CAM
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Fredi Kronenberg Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010712     History of Changes
Obsolete Identifiers: NCT00009386
Other Study ID Numbers: P50 AT000090-01P3, P50 AT000090-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Menopause
Hot Flashes
Osteoporosis
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Hot Flashes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014