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Screening Herbs for Drug Interactions - Article


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Clinical Trial: Screening Herbs for Drug Interactions

This study is no longer recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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

Condition Treatment or Intervention Phase
Healthy
 Drug: herbals
Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study

Official Title: R-21 Project: Screening Herbs for Drug Interference

Further Study Details: 

Expected Total Enrollment:  140

Study start: August 2001;  Study completion: November 2003

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.

Eligibility

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Normal healthy volunteers who are taking no medications.
  • Must be non-smokers.

Location Information


South Carolina
      Institute of Psychiatry, Medical University of SC, Charleston,  South Carolina,  29425,  United States

More Information

Study ID Numbers:  1 R21 AT00511-01
Record last reviewed:  January 2005
Last Updated:  January 19, 2005
Record first received:  January 9, 2002
ClinicalTrials.gov Identifier:  NCT00029263
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

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December 2, 2009



Page Updated: June 20, 2006
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