Effect of Prophylactic Use of Silymarin on Hepatotoxicity... | NCT01436929

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

NCT01436929

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 17, 2012Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Tuberculosis

Interventions

Silymarin
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BRMH-06-2011-75	Other Identifier	SeoulNUH

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 16, 2011

First Submission Date that Met QC Criteria

Sep 19, 2011

First Posted Date

Sep 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silymarin	Experimental	Silymarin: prophylactic administration of silymarin with anti-TB drugs Placebo: prophylactic administration of placebo with anti-TB drugs	Drug: Silymarin
Placebo	Placebo Comparator	administration of placebo with anti-TB drugs	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silymarin	Drug	Silymarin 140mg 1tab bid for 8 weeks	Silymarin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
incidence of hepatotoxicity by genotypic variants		8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Deog Kyeom Kim, M.D.	Contact	82-2-870-2228		kimdkmd@gmail.com

Overall Officials

Name	Affiliation	Role
Deog Kyeom Kim, M.D.	SMG-SNUH Bormae Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deog Kyeom Kim	Recruiting	Seoul		156-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012838	Silymarin

Ancestor Terms

ID	Term
D044947	Flavonolignans
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

Browse Leaves

Not provided

Browse Branches

Not provided