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Effect of silymarin in prevention of adverse effects of anti tuberculosis drugs.

Evaluation of Silymarin in prevention of anti tuberculosis drug induced hepatitis in patients newly diagnosed with tuberculosis.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000621011
Enrollment
72
Registered
2010-07-29
Start date
2010-08-01
Completion date
2010-11-09
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One of most important adverse effects of anti tuberculosis drugs is drug induced hepatitis. Adverse effects of drugs are one of causes for treatment interruption. Purpose of this study is prevention or decreasing incidence of drug induced hepatitis.

Interventions

Silymarin 420 mg per day, for the first 2 weeks of anti-tuberculosis treatment, as oral tablets

Sponsors

National Institute of Tuberculosis and Lung Disease (NRITLD)
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

New cases of tuberculosis

Exclusion criteria

1. Infection with Human Immune deficiency virus 2. Infection with hepatitis B virus 3. Infection with hepatitis c virus 4. Abnormal liver function tests in the base 5. Patients treated with the regimens other than Isoniazide, Rifampin, Pyrazinamide.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026