NCT01800487

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	silymarin	140 mg three times a day for 4 weeks
DRUG	Placebo	Placebo (silymarin) 1 tab three times a day for 4 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2013-02-27
• Last updated: 2013-12-24

Locations

1 site across 1 country: Thailand