The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Drug: silymarin; Drug: Placebo

• Registration Number: NCT01800487
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed its efficacy to decreased serum alanine transaminase enzyme in animal models from recent study. No confirmed this efficacy was performed in human.

A prospective, double-blind, placebo-controlled trial was carried out according to Good Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study. New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily. Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the level of ALT by week 4 and the number of patients who developed atb-DILI.

Statistical analysis is used to compare the differences in ALT and number of atb-DILI

Detailed Description

- Prevention of antituberculosis-related drug induced liver injury with silymarin is investigated.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-27
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• tuberculosis cases
• treated with isoniazid, rifampicin, ethambutol and pyrazinamide

Exclusion Criteria

• no known liver disease (HBV, HCV), and HIV infection
• normal ALT level before enrollment
• refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silymarin	silymarin	Silymarin 140 mg three times a day for 4 weeks
placebo	Placebo	Placeo 1 tab three times a day for 4 weeks

Primary Outcome Measures

Name	Time	Method
The number of patients who develop drug-induced liver injury (DILI) at 4 weeks	4 weeks	DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of total bilirubin more than 2 mg/dl with or without ALT elevation.

Trial Locations

Locations (1)

Gastroenterology and Hepatology, Ramathibodi hospital; 🇹🇭 Bangkok, Thailand