Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs
PESOHHERZ
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 17, 2012
December 1, 2012
2.1 years
September 16, 2011
December 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of hepatotoxicity
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.
8 weeks
Secondary Outcomes (1)
incidence of hepatotoxicity by genotypic variants
8 weeks
Study Arms (2)
Silymarin
EXPERIMENTALSilymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs
Placebo
PLACEBO COMPARATORadministration of placebo with anti-TB drugs
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- basal AST \>40 IU/uL or ALT \>40 IU/uL
- pregnancy
- lactating women
- cases with history of adverse events to silymarin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deog Kyeom Kim
Seoul, 156-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Deog Kyeom Kim, M.D.
SMG-SNUH Bormae Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
September 20, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
December 17, 2012
Record last verified: 2012-12