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Can N-Acetylcysteine prevent liver problems in TB patients?

Role of N-Acetylcysteine as prophylactic drug for Antitubercular drug induced hepatitis - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086686
Enrollment
100
Registered
2025-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15-A19- Tuberculosis

Interventions

Intervention1: N-Acetylcysteine with standard antitubercular therapy: N-Acetylcysteine at a dose of 600 mg two oral tablets daily for one month upon clinicoradiological and or microbiological evidence

Sponsors

Department of Internal Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed TB. 2. Started on standard dose of anti-TB drugs regimen. 3. Patient with normal hepatic transaminases and bilirubin values at baseline. 4. Patient with clinical and radiological and/or microbiological evidence of tuberculosis

Exclusion criteria

Exclusion criteria: 1. Patient with age less than 18 years. 2. Previous TB infection or Multi Drug Resistant TB. 3.Not willing to consent for the study. 4. Hypersensitivity to N-Acetylcysteine. 5. Pregnant females. 6. Patients with Glasgow Comma Scale score less than 8. 7. Patients with deranged hepatic transaminases and or bilirubin at baseline. 8. Patient with peptic ulcer disease

Design outcomes

Primary

MeasureTime frame
1. To calculate the difference in incidence of DILI in both treatment arms. Timepoint: 2 weeks,4 weeks and 8 weeks and if participant becomes symptomatic for ATT induced hepatitis.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Neha Sood

PGIMER Chandigarh

atulsaroch@gmail.com7289873798

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026