Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029263
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-09
Brief Title:
Screening Herbs for Drug Interactions
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
R-21 Project Screening Herbs for Drug Interference
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to detect potential herb-drug interactions in volunteers
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None