Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Drug Induced Liver Injury Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Gram-Positive Bacterial Infections Infections Liver Diseases Mycobacterium Infections Poisoning Tuberculosis Tuberculosis (TB)

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silymarin 420 mg

Drug

silymarin group received silymarin 140mg thrice daily along with antituberculous drugs for 14 days

n acetyl cysteine

Drug

N- acetylcysteine group will receive N-acetylcysteine 900mg once daily with antituberculous drugs for 14 days

Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Drug

Antituberculous drugs only

Primary outcomes

  1. Anti-Tuberculous Drug induced Hepatotoxicity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariba Sultan, MBBS

CONTACT

[email protected]

+92 302 9887711

shameem behram khan, fcps

CONTACT

[email protected]

+92 332 2397924

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.