Effect of N-ACETYLCYSTEINE In Treatment of Antitubercular drug induced liver injury.

EFFICACY OF N-ACETYL CYSTEINE IN ANTITUBERCULAR DRUG INDUCED HEPATOTOXICITY – A RANDOMISED CONTROL STUDY - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061627

Enrollment

Registered

2024-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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: Tab. N-ACETYLCYSTEINE 600mg twice daily after food till reintroduction of ATT or maximum till 28th day Control Intervention1: standard of care: till reintroduction of

Eligibility

Inclusion criteria

Inclusion criteria: Patient diagnosed with antitubercular drug induced hepatotoxicity. Patients Age >18 year of either sex and meet the all / any of the following criteria: (i) a rise of five times the upper limit of normal levels of serum AST and/or ALT without symptom of hepatotoxicity. (ii) a rise of two times the upper limit of normal level of serum bilirubin. (iii) More than 3 times increase in AST and/or ALT levels together with the hepatitis symptoms

Exclusion criteria

Exclusion criteria: 1.History of alcoholism and known case of alcoholic liver disease. 2. Known case of HIV, HBV, HCV. 3. Liver injury due to drugs other than ATT. 4. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Difference in mean duration to restart the therapy in NAC group and standard care group.Timepoint: 3,7,14,21,28 days	—

Secondary

Measure	Time frame
Change in TB composite score.Timepoint: 0,28 day;Improvement in symptoms of hepatitis from baseline (at time of DILI) till restart of therapy.Timepoint: 0,3,7,14,21,28 days;Recurrence of drug induced liver injury.Timepoint: till the completion of Antitubercular therapy;safety of N - ACETYLCYSTEINETimepoint: 3,7,14,21,28 DAY;To assess the plasma concentration of NAC using HPLC (High performance liquid chromatography).Timepoint: till reintroduction of antitubercular therapy or 0,3,7,28 days maximum	—

Measure

Time frame

Change in TB composite score.Timepoint: 0,28 day;Improvement in symptoms of hepatitis from baseline (at time of DILI) till restart of therapy.Timepoint: 0,3,7,14,21,28 days;Recurrence of drug induced liver injury.Timepoint: till the completion of Antitubercular therapy;safety of N - ACETYLCYSTEINETimepoint: 3,7,14,21,28 DAY;To assess the plasma concentration of NAC using HPLC (High performance liquid chromatography).Timepoint: till reintroduction of antitubercular therapy or 0,3,7,28 days maximum

—

Countries

India

Contacts

Public ContactDr.Mohit dadhich

AIIMS Jodhpur

sr_ambwani@yahoo.com9414912698

Outcome results

None listed

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