Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs (PESOHHERZ)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs|
- incidence of hepatotoxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- incidence of hepatotoxicity by genotypic variants [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs
Silymarin 140mg 1tab bid for 8 weeks
Placebo Comparator: Placebo
administration of placebo with anti-TB drugs
Placebo 1tab bid
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436929
|Contact: Deog Kyeom Kim, M.D.||email@example.com|
|Korea, Republic of|
|Deog Kyeom Kim||Recruiting|
|Seoul, Korea, Republic of, 156-707|
|Contact: Deog Kyeom Kim, M.D. 82-2-870-2228 firstname.lastname@example.org|
|Sub-Investigator: Chang-Hoon Lee, M.D|
|Sub-Investigator: Eun-young Heo, M.D.|
|Sub-Investigator: Seo-Yoon Kim, M.D.|
|Study Director:||Deog Kyeom Kim, M.D.||SMG-SNUH Bormae Medical Center|