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| ID | Type | Description | Link |
|---|---|---|---|
| P50AT000155-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cimicifuga racemosa | Drug | |||
| Trifolium pratense | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Banuvar, MHSA, CCRC | University of Illinois at Chicago | Study Director |
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| Label | URL |
|---|---|
| Click here for information on the UIC/NIH Center for Botanical Dietary Supplements Research | View source |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713173 | black cohosh root extract |
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