An Assessment of Milk Thistle Pharmacokinetics and Drug Interactions

NCT00200798 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2018-07-17

No results posted yet for this study

Summary

There is accumulating evidence from various sources that extracts from the milk thistle plant can be useful in the treatment of a variety of liver ailments as well as other disorders. This investigation will essentially be composed of two individual normal volunteer studies of milk thistle. The first study will assess the rate and extent of absorption of components of a standardized botanical extract obtained from the milk thistle plant. This first study is termed a bioavailability study. This investigation will take approximately 8 weeks and involve 10 clinic visits. Secondly, a drug interaction study will be performed. This is an assessment study of the potential for this botanical extract to interact with other prescription or over-the-counter medications. This study is also expected to take approximately 8 weeks but will involve 18 clinic visits. In both studies all subjects will receive the same milk thistle supplement and no placebo will be administered.

Conditions

  • Healthy

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • Office of Dietary Supplements (ODS)

    collaborator NIH
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • John S. Markowitz, Pharm.D. · Medical University of South Carolina

  • Thomas W Uhde, MD · Medical University of South Carolina

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00200798 on ClinicalTrials.gov