Single-Dose Study of Black Cohosh and Red Clover

March 1, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

National Institute of General Medical Sciences (NIGMS)
Office of Dietary Supplements (ODS)

Investigators

  • Study Director: Suzanne Banuvar, MHSA, CCRC, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion

February 1, 2002

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (ESTIMATE)

February 5, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2007

Last Update Submitted That Met QC Criteria

March 1, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P50AT000155-01P4 (NIH)
  • P50AT000155-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menopause

Clinical Trials on Cimicifuga racemosa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe