The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
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|ClinicalTrials.gov Identifier: NCT01800487|
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : December 24, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Drug: silymarin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: silymarin
Silymarin 140 mg three times a day for 4 weeks
140 mg three times a day for 4 weeks
Placebo Comparator: placebo
1 tab three times a day for 4 weeks
Placebo (silymarin) 1 tab three times a day for 4 weeks
- The number of patients who develop drug-induced liver injury (DILI) at 4 weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800487
|Gastroenterology and Hepatology, Ramathibodi hospital|
|Bangkok, Thailand, 10400|
|Study Director:||Abhasnee Sobhonslidsuk, MD||Ramathibodi Hospital|
|Principal Investigator:||Chote Luangchosiri, MD||Ramathibodi|