Clinical trial NCT01800487: The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
Official title: The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Drug-induced liver injury
Tuberculosis
Silymarin
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of patients who develop drug-induced liver injury (DILI) at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Gastroenterology and Hepatology, Ramathibodi hospital
Study officials:
affiliation: Ramathibodi Hospital
name: Abhasnee Sobhonslidsuk, MD
role: STUDY_DIRECTOR
affiliation: Ramathibodi
name: Chote Luangchosiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luangchosiri C, Thakkinstian A, Chitphuk S, Stitchantrakul W, Petraksa S, Sobhonslidsuk A. A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury. BMC Complement Altern Med. 2015 Sep 23;15:334. doi: 10.1186/s12906-015-0861-7.