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Single-Dose Study of Black Cohosh and Red Clover

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00010959
First Posted: February 5, 2001
Last Update Posted: March 2, 2007
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.
Collaborators:
National Institute of General Medical Sciences (NIGMS)
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  Purpose
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.

Condition Intervention Phase
Menopause Drug: Cimicifuga racemosa Drug: Trifolium pratense Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:
  • safety

Estimated Enrollment: 30
Study Start Date: February 2001
Estimated Study Completion Date: February 2002
Detailed Description:
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. The study will be randomized, double-blinded, and placebo-controlled. Study duration will be one year.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy menopausal women
  • Average body weight
  • Able to give informed consent

Exclusion Criteria:

  • Smoker
  • Use of any prescription medicine within the last 2 months
  • Obesity > 30% above ideal body weight
  • Previous history of breast or reproductive cancer
  • Alcohol abuse or consumption above 5 glasses of wine per week or equivalent
  • Chronic disease such as diabetes or hypertension
  • Concurrent non-dietary phytoestrogens or hormone use; Vegans (vegetarians who tend to consume greater than average dose of phytoestrogens)
  • Concurrent participation in other clinical trial(s)
  • Unavailable for followup
  Contacts and Locations
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): NCT00010959


Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
National Institute of General Medical Sciences (NIGMS)
Office of Dietary Supplements (ODS)
Investigators
Study Director: Suzanne Banuvar, MHSA, CCRC University of Illinois at Chicago
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00010959     History of Changes
Obsolete Identifiers: NCT00008970
Other Study ID Numbers: P50AT000155-01P4 ( U.S. NIH Grant/Contract )
P50AT000155-01 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2001
First Posted: February 5, 2001
Last Update Posted: March 2, 2007
Last Verified: March 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
menopause
hot flashes
botanicals