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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01436929

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Months)

22.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Drug: Silymarin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

incidence of hepatotoxicity [8 weeks]
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 [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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