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Single-Dose Study of Black Cohosh and Red Clover

NCT00010959 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-03-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cimicifuga racemosa

DRUG

Trifolium pratense

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Suzanne Banuvar, MHSA, CCRC · University of Illinois at Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-02-28
Completion
2002-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010959 on ClinicalTrials.gov