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

Primary Purpose

Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silymarin
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring silymarin, hepatotoxicity, tuberculosis, HREZ

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deog Kyeom KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silymarin

Placebo

Arm Description

Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs

administration of placebo with anti-TB drugs

Outcomes

Primary Outcome Measures

incidence of hepatotoxicity
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

Full Information

First Posted
September 16, 2011
Last Updated
December 13, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01436929
Brief Title
Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs
Acronym
PESOHHERZ
Official Title
Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
silymarin, hepatotoxicity, tuberculosis, HREZ

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silymarin
Arm Type
Experimental
Arm Description
Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
administration of placebo with anti-TB drugs
Intervention Type
Drug
Intervention Name(s)
Silymarin
Intervention Description
Silymarin 140mg 1tab bid for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1tab bid
Primary Outcome Measure Information:
Title
incidence of hepatotoxicity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
incidence of hepatotoxicity by genotypic variants
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Kyeom Kim, M.D.
Phone
82-2-870-2228
Email
kimdkmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Kyeom Kim, M.D.
Organizational Affiliation
SMG-SNUH Bormae Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Deog Kyeom Kim
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Kyeom Kim, M.D.
Phone
82-2-870-2228
Email
kimdkmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, M.D
First Name & Middle Initial & Last Name & Degree
Eun-young Heo, M.D.
First Name & Middle Initial & Last Name & Degree
Seo-Yoon Kim, M.D.

12. IPD Sharing Statement

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

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