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CompletedNCT00029263Updated Aug 18, 2006

Screening Herbs for Drug Interactions

A Phase 2 interventional study of herbals in Healthy, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-08-18.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Normal healthy volunteers who are taking no medications.
  • Must be non-smokers.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants

Interventions

  • Drugherbals
06

Study locations

1 site
  • Institute of Psychiatry, Medical University of SC
    Charleston, South Carolina 29425, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00029263
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
First posted
Jan 10, 2002
Start date
Aug 2001
Completion
May 2004
Last update
Aug 18, 2006

Study contacts

John Markowitz, MD
principal investigator · Medical University of South Carolina
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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