Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

Summary

Intervention - Subjects will be randomized to 2 groups Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine) Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h * Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals. * Stopping rule-Development of sepsis, worsening of Liver functions.

Timeline

Start

2016-03-01

Primary completion

2016-08-31

Completion

2016-08-31

Drugs

Indications