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

Not Applicable

Not yet recruiting

• Conditions: Drug Induced Liver Injury; Tuberculosis (TB)
• Interventions: Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z); Drug: Silymarin 420 mg; Drug: N Acetyl Cysteine

• Registration Number: NCT07058090
• Lead Sponsor: Liaquat National Hospital & Medical College

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-12
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

• Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age
• either gender.

Exclusion Criteria

• History of malignancy.
• Patients with history of seropositive, seronegative, connective tissue disorder or vasculitis, congestive cardiac failure.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)	patients taking antituberculous drugs only
group A	Silymarin 420 mg	patients taking antituberculous drugs with silymarin
group B	N Acetyl Cysteine	patients taking antituberculous drugs with N-acetylcysteine

Primary Outcome Measures

Name	Time	Method
Anti-Tuberculous Drug induced Hepatotoxicity	14 days	Outcome will be assessed in patients developing Anti-tuberculous Drug-Induced Hepatotoxicity. Patients diagnosed with TB and started on a regimen based on isoniazid, rifampicin, pyrazinamide, and ethambutol will be labeled as having Anti-tuberculous Drug-Induced Hepatotoxicity using liver function tests. It will be labeled if any one of the following criteria is met: * Rise in alanine aminotransferase (ALT) more than or equal to a fivefold increase from the upper limit of normal (\>37 IU/L); * Rise in alkaline phosphatase (ALP) more than or equal to twofold increase from the upper limit of normal (\>147 IU/L).; * An increase in alanine aminotransferase (ALT) to three or more times the upper normal limit (greater than 37 IU/L), accompanied by a simultaneous rise in bilirubin levels to more than twice the upper normal limit (exceeding 1.5 mg/dL), will be considered significant.