Overview

Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs

Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
Tuberculosis is a worldwide common infectious disease and effective first line anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation of anti-TB drugs or changing anti-Tb drug regimen. Silymarin has been widely studied for the effect on hepatitis and it has been used in hepatology. Therefore, the investigators hypothesized that prophylactic administration of silymarin with anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB drugs.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Antitubercular Agents
Silymarin
Criteria
Inclusion Criteria:

- subjects who are diagnosed with tuberculosis based on microbiological, biomolecular,
pathological, or radiographical findings and are expecting to be administered with
anti-tuberculosis drugs including INH, RFP, or PZA.

- adults >=35 years old

Exclusion Criteria:

- basal AST >40 IU/uL or ALT >40 IU/uL

- pregnancy

- lactating women

- cases with history of adverse events to silymarin