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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Institute of General Medical Sciences (NIGMS) Office of Dietary Supplements (ODS) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00010959 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age |
Estimated Enrollment: | 30 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | February 2002 |
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.
Ages Eligible for Study: | 45 Years to 59 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P50 AT000155-01P4, P50 AT000155-01 |
Study First Received: | February 2, 2001 |
Last Updated: | March 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00010959 |
Health Authority: | United States: Federal Government |
menopause hot flashes botanicals |
Hot Flashes Healthy Menopause |