Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs (PESOHHERZ)
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|ClinicalTrials.gov Identifier: NCT01436929|
Recruitment Status : Unknown
Verified December 2012 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : September 20, 2011
Last Update Posted : December 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Drug: Silymarin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
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
- incidence of hepatotoxicity [ Time Frame: 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.
- incidence of hepatotoxicity by genotypic variants [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436929
|Contact: Deog Kyeom Kim, M.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Deog Kyeom Kim||Recruiting|
|Seoul, Korea, Republic of, 156-707|
|Contact: Deog Kyeom Kim, M.D. 82-2-870-2228 email@example.com|
|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|