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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT007869-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.
24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo given for 5 days (qd po) |
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| Icariin - 100 mg/day | Active Comparator | Icariin given at 100 mg/day (qd po) for 5 days |
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| Icariin - 200 mg/day | Active Comparator | Icariin given at 200 mg/day (qd po) for 5 days |
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| Icariin - 400 mg/day | Active Comparator | Icariin given at 400 mg/day (qd po) for 5 days |
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| Icariin - 840 mg/day | Active Comparator | Icariin given at 840 mg/day (qd po) for 5 days |
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| Icariin - 1680 mg/day | Active Comparator | Icariin given at 1680 mg/day (qd po) for 5 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icariin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration levels of icariin | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| A-SEX | Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning. | 5 days |
| SAFTEE | Systematic Assessment for Treatment Emergent Events - to assess general side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Sherwood Brown, M.D., Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| C056599 | icariin |
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| Matching placebo | Dietary Supplement |
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| 5 days |
| PT/PTT levels | Prothrombin time/Partial thromboplastin time | 5 days |