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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800487
• Other study ID #: Ramathibodi_silymarin
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: December 23, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/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
140 mg three times a day for 4 weeks
• Placebo
Placebo (silymarin) 1 tab three times a day for 4 weeks

Locations

Country	Name	City	State
Thailand	Gastroenterology and Hepatology, Ramathibodi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients who develop drug-induced liver injury (DILI) at 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.	4 weeks	No