NCT00200798

Completed

An Assessment of Milk Thistle Pharmacokinetics and Drug Inte...

Medical University of South Carolina Source

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Other study identifiers

Sponsor study identifier

R21AT002817-01

NIH

Secondary identifiers

R21AT002817-01

NIH

Study Type

observational

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2007

Actual (reported)

Study Completion

August 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: August 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 13, 2005
Actual (reported)
First Posted
September 20, 2005
Actual (reported)
Study Start
May 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2007
Actual (reported)
Study Completion
August 2007
Actual (reported)

Last Updated: July 17, 2018
Status Verified: April 2018
Last Update Submitted: July 16, 2018

Conditions

Healthy

Keywords

Milk ThistleSilymarinpharmacokineticsdrug interactionsNormal volunteers

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Normal healthy volunteers

You may qualify if:

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.

Sponsors & Collaborators

Medical University of South Carolina
Otherlead
Office of Dietary Supplements (ODS)
NIHcollaborator

Study Sites (1)

Medical University of South Carolina, GCRC

Charleston, South Carolina, 29425, United States

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma \& urine

Study Officials

John S. Markowitz, Pharm.D.
Medical University of South Carolina
PRINCIPAL INVESTIGATOR
Thomas W Uhde, MD
Medical University of South Carolina
STUDY CHAIR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

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You may not qualify if:

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)

Contact the study team to confirm eligibility.

National Center for Complementary and Integrative Health (NCCIH)

NIHcollaborator

Primary Completion

August 2007

Actual (reported)

Study Completion

August 2007

Actual (reported)

Last Updated

July 17, 2018

Record last verified: 2018-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00200798
Data provider: ClinicalTrials.gov
Source updated: 2018-07-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:50 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations