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

Liaquat National Hospital & Medical College

Status and phase: Not yet enrolling; Phase 1

Conditions: Drug Induced Liver Injury; Tuberculosis (TB)

Treatments: Drug: Silymarin 420 mg; Drug: N Acetyl Cysteine; Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Study type: Interventional

Funder types: Other

Identifiers

NCT07058090

1188-2025-LNH-ERC

Details and patient eligibility

About

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

Enrollment: 410 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 3 patient groups

group C

Active Comparator group

Description:

patients taking antituberculous drugs only

Treatment:

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

group A

Experimental group

Description:

patients taking antituberculous drugs with silymarin

Treatment:

Drug: Silymarin 420 mg

group B

Experimental group

Description:

patients taking antituberculous drugs with N-acetylcysteine

Treatment:

Drug: N Acetyl Cysteine