drugset / Trial / NCT01436929

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

NCT01436929

Unknown 600 enrolled Seoul National University Hospital
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2011-09
Primary completion
2013-10
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 140 mg

Indications