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An Assessment of Milk Thistle Pharmacokinetics and Drug Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200798
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 17, 2018
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by:
Medical University of South Carolina

Brief 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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pharmacokinetics and Drug Interactions With Milk Thistle
Study Start Date : May 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Biospecimen Retention:   Samples Without DNA
plasma & urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal healthy volunteers

Inclusion Criteria:

  • Age range: 18-45 years old
  • Race or ethnicity: no restrictions
  • Health status: subjects must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
  • Must have no history of significant psychiatric illness or substance use.
  • Written Informed Consent as well as Health Insurance Portability and Accountability Act (HIPAA) authorization forms must be signed by the eligible subject prior to the initiation of any study procedures.

Exclusion Criteria:

Any of the following conditions are cause for exclusion and/or discontinuation from the study:

  • The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion.
  • A positive urine pregnancy test
  • The use of oral contraceptives
  • The lack of use of acceptable barrier methods of birth control unless abstinent
  • The use of any concomitant medication including herbal medications, over-the-counter (OTC) supplements, or a history of hypersensitivity to DM, ALPZ, TOL, or caffeine (CAF) and any history of sensitivity to milk thistle or any of its components.
  • Subjects genotyped as poor metabolizers of CYP2D6 at screening
  • Active smoking or use of CAF containing beverage (coffee, certain colas) for one week prior and during the study period due to known effects on CYP1A2 activity.
  • Subjects expressing inability to conform to dietary restrictions required for the study
  • The use of any illicit drugs or habitual consumption of large quantities of ethanol (> 3 drinks/day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200798

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United States, South Carolina
Medical University of South Carolina, GCRC
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
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Principal Investigator: John S. Markowitz, Pharm.D. Medical University of South Carolina
Study Chair: Thomas W Uhde, MD Medical University of South Carolina
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Responsible Party: John S. Markowitz, Pharm.D., MUSC Identifier: NCT00200798    
Other Study ID Numbers: R21AT002817-01 ( U.S. NIH Grant/Contract )
R21AT002817-01 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: April 2018
Keywords provided by Medical University of South Carolina:
Milk Thistle
drug interactions
Normal volunteers