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

Seoul National University

Status: Unknown

Conditions: Tuberculosis

Treatments: Drug: Placebo; Drug: Silymarin

Study type: Interventional

Funder types: Other

Identifiers

NCT01436929

BRMH-06-2011-75 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Silymarin

Experimental group

Description:

Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs

Treatment:

Drug: Silymarin

Placebo

Placebo Comparator group

Description:

administration of placebo with anti-TB drugs

Treatment:

Drug: Placebo