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

Tuberculosis Clinical Trial

— PESOHHERZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01436929
• Other study ID #: BRMH-06-2011-75
• Secondary ID: BRMH-06-2011-75
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2011
• Last updated: December 13, 2012
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Seoul National University Hospital
• Contact: Deog Kyeom Kim, M.D.
• Phone: 82-2-870-2228
• Email: kimdkmd[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• Silymarin
Silymarin 140mg 1tab bid for 8 weeks
• Placebo
Placebo 1tab bid

Locations

Country	Name	City	State
Korea, Republic of	Deog Kyeom Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of hepatotoxicity by genotypic variants		8 weeks	No