Evaluation of the effect of Milk Thistle in the prevention of anti-tuberculosis drugs-induced hepatotoxicity: A randomized controlled clinical trial
Not Applicable
- Conditions
- Anti-tuberculosis drugs-induced hepatotoxicity.Toxic liver disease
- Registration Number
- IRCT20150721023282N9
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
Age = 18 years
Pulmonary or outer pulmonary tuberculosis
Taking first line of anti-TB drugs (Isoniazid, Rifampin and Pyrazinamide)
No use of first-line anti-TB drugs within the last 8 weeks
Exclusion Criteria
Use of known hepatotoxic drugs (e.g., sodium valproate, methotrexate, sulfonamides)
Regular use of acetaminophen
Use of systemic glucocorticoids
Use of Silymarin-containing supplements within the last 4 weeks
Alcoholism
Use of antioxidant agents (e.g., vitamins E and C)
Having chronic hepatic or renal disease
Pregnancy
Lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum level of ALT. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of AST. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of ALP. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of bilirubin(direct/total). Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.
- Secondary Outcome Measures
Name Time Method