Evaluation of the effect of the combination of coenzyme Q10, alpha-lipoic acid, and acetyl-L-carnitine in the prevention of anti-tuberculosis drugs-induced hepatic adverse effect
Phase 2
- Conditions
- Anti-tuberculosis drugs-induced hepatotoxicity.Toxic liver disease
- Registration Number
- IRCT20150721023282N11
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Age = 18 years
Pulmonary or extrapulmonary tuberculosis
Taking first-line 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 any supplements containing coenzyme Q10 or alpha-lipoic acid or L-carnitine 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 alanine aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of aspartate aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of alkaline phosphatase. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of total bilirubin. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;The number of cases of drug-induced liver injury. Timepoint: End of intervention. Method of measurement: Based on defined criteria.
- Secondary Outcome Measures
Name Time Method