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

NCT ID: NCT01436929

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Tuberculosis

Keywords

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silymarin hepatotoxicity tuberculosis HREZ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Silymarin

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

Group Type EXPERIMENTAL

Silymarin

Intervention Type DRUG

Silymarin 140mg 1tab bid for 8 weeks

Placebo

administration of placebo with anti-TB drugs

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1tab bid

Interventions

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Silymarin

Silymarin 140mg 1tab bid for 8 weeks

Intervention Type DRUG

Placebo

Placebo 1tab bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deog Kyeom Kim, M.D.

Role: STUDY_DIRECTOR

SMG-SNUH Bormae Medical Center

Locations

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Deog Kyeom Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Deog Kyeom Kim, M.D.

Role: CONTACT

Phone: 82-2-870-2228

Email: [email protected]

Facility Contacts

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Deog Kyeom Kim, M.D.

Role: primary

Other Identifiers

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BRMH-06-2011-75

Identifier Type: OTHER

Identifier Source: secondary_id

BRMH-06-2011-75

Identifier Type: -

Identifier Source: org_study_id