Single-Dose Study of Black Cohosh and Red Clover

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2002-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Menopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cimicifuga racemosa

Intervention Type DRUG

Trifolium pratense

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes