Tuberculosis
Conditions
Keywords
silymarin, hepatotoxicity, tuberculosis, HREZ
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.
Interventions
DRUGSilymarin
Silymarin 140mg 1tab bid for 8 weeks
DRUGPlacebo
Placebo 1tab bid
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| incidence of hepatotoxicity by genotypic variants | 8 weeks |
Countries
South Korea
Contacts
Primary ContactDeog Kyeom Kim, M.D.
Outcome results
None listed