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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78545137

Enrollment

Registered

2002-11-06

Start date

2003-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug interactions Not Applicable

Interventions

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], alani

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026