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Screening Herbs for Drug Interactions
This study has been completed.
Study NCT00029263   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: January 9, 2002   Last Updated: August 17, 2006   History of Changes

January 9, 2002
August 17, 2006
August 2001
 
 
 
Complete list of historical versions of study NCT00029263 on ClinicalTrials.gov Archive Site
 
 
 
Screening Herbs for Drug Interactions
R-21 Project: Screening Herbs for Drug Interference

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

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.

Phase II
Interventional
Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Healthy
Drug: herbals
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
140
May 2004
 

Inclusion Criteria:

  • Normal healthy volunteers who are taking no medications.
  • Must be non-smokers.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029263
 
R21 AT000511-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: John Markowitz, MD Medical University of South Carolina
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP