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

NCT01436929 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2012-12-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Silymarin

Silymarin 140mg 1tab bid for 8 weeks

DRUG

Placebo

Placebo 1tab bid

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Deog Kyeom Kim, M.D. · SMG-SNUH Bormae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436929 on ClinicalTrials.gov