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Icariin to Prevent Corticosteroid-related Memory Changes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02112123
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
the Pharmacokinetic Profile of Icariin in Humans Drug: Icariin Dietary Supplement: Matching placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Icariin to Prevent Corticosteroid-related Memory Changes
Study Start Date : April 2014
Primary Completion Date : September 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Blood concentration levels of icariin [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. A-SEX [ Time Frame: 5 days ]
    Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.

  2. SAFTEE [ Time Frame: 5 days ]
    Systematic Assessment for Treatment Emergent Events - to assess general side effects

  3. PT/PTT levels [ Time Frame: 5 days ]
    Prothrombin time/Partial thromboplastin time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112123


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center

Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02112123     History of Changes
Other Study ID Numbers: 102012-052
1R21AT007869-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Sherwood Brown, University of Texas Southwestern Medical Center:
icariin
pharmacokinetics
healthy participants