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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Drug Induced Liver Injury Tuberculosis (TB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group C

patients taking antituberculous drugs only

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Antituberculous drugs only

group A

patients taking antituberculous drugs with silymarin

Group Type EXPERIMENTAL

Silymarin 420 mg

Intervention Type DRUG

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

group B

patients taking antituberculous drugs with N-acetylcysteine

Group Type EXPERIMENTAL

N Acetyl Cysteine

Intervention Type DRUG

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

Interventions

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Silymarin 420 mg

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

Intervention Type DRUG

N Acetyl Cysteine

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

Intervention Type DRUG

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

Antituberculous drugs only

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No