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Screening Herbs for Drug Interactions

Sponsor
National Center for Complementary and Integrative Health (NCCIH) (NIH)
Overall Status
Completed
CT.gov ID
NCT00029263
Collaborator
(none)
140
Enrollment
1
Location
33
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to detect potential herb-drug interactions in volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The use of herbal medicines in the treatment of various medical and psychiatric conditions has accelerated in the last decade. It has also become evident that herbal medications are being used concomitantly with conventional prescription and over-the-counter medications. However, the systematic evaluation of the potential of these agents to interact with conventional medications has been generally neglected. Compounding this problem is the fact that even single entity herbal products can contain a multitude of naturally occurring chemicals which serve as candidates for potential herb-drug interactions by inhibiting or inducing specific hepatic isozymes. Numerous reports document the importance of pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP) enzyme system. In this study, the ten most commonly used herbal products in the US will be systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4. Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all marketed medications.

Participants in this study will receive a single dose of the prescription drug alprazolam and the over-the-counter cough suppressant, dextromethorphan on two occasions. A combination of probe drugs will be given to normal volunteers both in the absence and presence of herbal medications. The plasma and urine concentration of these agents and their respective metabolites will be determined in order to evaluate individual herbal products degree and specificity of enzyme inhibitory or inductive effects.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
R-21 Project: Screening Herbs for Drug Interference
Study Start Date :
Aug 1, 2001
Study Completion Date :
May 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    • Normal healthy volunteers who are taking no medications.

    • Must be non-smokers.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Psychiatry, Medical University of SC Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: John Markowitz, MD, Medical University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00029263
    Other Study ID Numbers:
    • R21AT000511-01
    First Posted:
    Jan 10, 2002
    Last Update Posted:
    Aug 18, 2006
    Last Verified:
    Jul 1, 2006

    Study Results

    No Results Posted as of Aug 18, 2006