Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs (PESOHHERZ)

This study is currently recruiting participants.
Verified December 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01436929
First received: September 16, 2011
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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 Intervention
Tuberculosis
Drug: Silymarin
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • incidence of hepatotoxicity by genotypic variants [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 16, 2011
Last Updated: December 13, 2012
Health Authority: Korea: Food and Drug Administration

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
Antitubercular Agents
Silymarin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014