Determining if ingestion of silybum marianum (milk thistle) influences the metabolisation of indinavir in healthy subjects: a randomised controlled phase I study

ISRCTN	ISRCTN78545137
DOI	https://doi.org/10.1186/ISRCTN78545137
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Edward Mills
Scientific

Director of Research, Canadian College of Naturopathic Medicine
1255 Sheppard Ave East
North York, Ontario
M2K 1E2
Canada

Phone	+1 416 498 1255 ext 324
Email	emills@ccnm.edu

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Drug interactions
Intervention	Milk thistle (silybum marianum) and indinavir. Twenty-four healthy male participants: All individuals will receive a HIV test and Liver Function Tests (LFTs - aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT]) to exclude HIV and liver disease, and also a Complete Blood Count (CBC). Subjects are requested to discontinue all medications, alcohol, caffeine, nicotine and other known CYP 3A4 inducers and inhibitors. Informed consent will be obtained from all participants.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Milk thistle, indinavir
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2003
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	24
Key inclusion criteria	1. Documented Enzyme-Linked Immunosorbent Assay (ELISA) and Western Blot results negative for Human Immunodeficiency Virus (HIV) 2. Aged 18 - 35 years 3. Sex male, race Caucasian, and normal findings of laboratory and physical examinations
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2005

Director of Research, Canadian College of Naturopathic Medicine

North York, Ontario
M2K 1E2
Canada

Ontario HIV Treatment Network
Not defined

1300 Yonge Street
Suite 308
Toronto, Ontario
M4T 1X3
Canada

Research organisation

Ontario HIV Treatment Network (Canada)
Government organisation / Local government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/03/2005		Yes	No