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

Seoul National University Hospital600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

600

Conditions

Tuberculosis

Interventions

Silymarin

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

incidence of hepatotoxicity

the presence of hepatotoxicity will be evaluated at 2weeks, 4weeks, and 8weeks after initiation of anti-TB drugs. An interim analysis will be done after enrolling first 300 subjects.

Time frame: 8 weeks

Secondary Outcomes

incidence of hepatotoxicity by genotypic variants