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

Not Applicable

• Conditions: Tuberculosis
• Interventions: Drug: Placebo; Drug: Silymarin

• Registration Number: NCT01436929
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
incidence of hepatotoxicity	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
incidence of hepatotoxicity by genotypic variants	8 weeks

Trial Locations

Locations (1)

Deog Kyeom Kim; 🇰🇷 Seoul, Korea, Republic of