Icariin to Prevent Corticosteroid-related Memory Changes

August 15, 2017 updated by: Sherwood Brown, University of Texas Southwestern Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo given for 5 days (qd po)
Dietary supplement: Matching placebo
Active Comparator: Icariin - 100 mg/day
Icariin given at 100 mg/day (qd po) for 5 days
Drug: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 200 mg/day
Icariin given at 200 mg/day (qd po) for 5 days
Drug: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 400 mg/day
Icariin given at 400 mg/day (qd po) for 5 days
Drug: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 840 mg/day
Icariin given at 840 mg/day (qd po) for 5 days
Drug: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 1680 mg/day
Icariin given at 1680 mg/day (qd po) for 5 days
Drug: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood concentration levels of icariin
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A-SEX
Time Frame: 5 days
Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.
5 days
SAFTEE
Time Frame: 5 days
Systematic Assessment for Treatment Emergent Events - to assess general side effects
5 days
PT/PTT levels
Time Frame: 5 days
Prothrombin time/Partial thromboplastin time
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 102012-052
  • 1R21AT007869-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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