NCT07058090

Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Liaquat National Hospital & Medical College · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi. SAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea) ,Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke will be excluded

Conditions

• Drug Induced Liver Injury
• Tuberculosis (TB)

Interventions

Type	Name	Description
DRUG	Silymarin 420 mg	silymarin group received silymarin 140mg thrice daily along with antituberculous drugs for 14 days
DRUG	N Acetyl Cysteine	N- acetylcysteine group will receive N-acetylcysteine 900mg once daily with antituberculous drugs for 14 days
DRUG	Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)	Antituberculous drugs only

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2025-07-10
• Last updated: 2025-07-10