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

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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.

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
(214) 645-8300
Principal Investigator: E. Sherwood Brown, M.D., Ph.D.
Phone: 214-645-6954
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