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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

NCT07058090 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-07-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Liaquat National Hospital & Medical College

    lead OTHER

Principal Investigators

  • Ariba Sultan · Liaquat National Hospital & Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2025-12-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058090 on ClinicalTrials.gov