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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014