Single-Dose Study of Black Cohosh and Red Clover - Full Text View

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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Menopause

Drug Information available for: Cimicifuga Red clover

U.S. FDA Resources

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

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

Ages Eligible for Study:	45 Years to 59 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010959

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Institute of General Medical Sciences (NIGMS)

Office of Dietary Supplements (ODS)

Investigators

Study Director:

Suzanne Banuvar, MHSA, CCRC

University of Illinois

More Information

Additional Information:

Click here for information on the UIC/NIH Center for Botanical Dietary Supplements Research This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00010959 History of Changes
Obsolete Identifiers:	NCT00008970
Other Study ID Numbers:	P50 AT000155-01P4, P50 AT000155-01
Study First Received:	February 2, 2001
Last Updated:	March 1, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

menopause
hot flashes
botanicals

ClinicalTrials.gov processed this record on May 16, 2013