Icariin to Prevent Corticosteroid-related Memory Changes
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 4/21/2016 |
Start Date: | April 2014 |
End Date: | December 2016 |
Contact: | Collette B. Bice, MS |
Email: | collette.bice@utsouthwestern.edu |
Phone: | 214-645-6954 |
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.
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.
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.
Inclusion Criteria:
- Healthy men and women
- Ages 18 - 50 years
- BMI between 18.5 and 30
- Ability to read and speak English
- Education of 12 or more years or equivalent (at least GED received)
Exclusion Criteria:
- Medication changes in the past 30 days
- History of psychotropic medication therapy in the past 30 days
- Current or past 30 days opioid therapy
- Current or past 30 days erectile dysfunction therapy
- Significant medical conditions
- Hypertensive blood pressure, defined as either systolic pressure > 140 or diastolic
pressure > 90
- Baseline heart rate > 100 bpm or < 50 bpm
- History of major psychiatric illness
- History of drug/alcohol abuse or current tobacco use
- Vulnerable populations including pregnant or nursing women, the incarcerated, or
individuals with severe cognitive disorders
- History of allergic reaction or contraindication to icariin
- Baseline QIDS score > 7, current suicidal ideation, or history of suicide attempt
- Education history that includes Special Education or history of mental disability
- Clinically significant abnormalities on baseline labs and ECG results
- Current participation in any other pharmacotherapy studies
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: E. Sherwood Brown, M.D., Ph.D.
Phone: 214-645-6954
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