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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
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Silymarin Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Silymarin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Silymarin
Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs
Drug: Silymarin
Silymarin 140mg 1tab bid for 8 weeks
Placebo Comparator: Placebo
administration of placebo with anti-TB drugs
Drug: Placebo
Placebo 1tab bid



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. incidence of hepatotoxicity by genotypic variants [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Deog Kyeom Kim, M.D. 82-2-870-2228 kimdkmd@gmail.com

Locations
Korea, Republic of
Deog Kyeom Kim Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Deog Kyeom Kim, M.D.    82-2-870-2228    kimdkmd@gmail.com   
Sub-Investigator: Chang-Hoon Lee, M.D         
Sub-Investigator: Eun-young Heo, M.D.         
Sub-Investigator: Seo-Yoon Kim, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Deog Kyeom Kim, M.D. SMG-SNUH Bormae Medical Center

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01436929     History of Changes
Other Study ID Numbers: BRMH-06-2011-75
BRMH-06-2011-75 ( Other Identifier: SeoulNUH )
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Seoul National University Hospital:
silymarin
hepatotoxicity
tuberculosis
HREZ

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Silymarin
Antitubercular Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents