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N-acetylcysteine as an add-on to antituberculosis chemotherapy and QB-Spot as an efficacy monitoring method in pulmonary tuberculosis patients: a prospective, single center, open label, randomized controlled trial

N-acetylcysteine as an add-on to antituberculosis chemotherapy and QB-Spot as an efficacy monitoring method in pulmonary tuberculosis patients: a prospective, single center, open label, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058813
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-05-01
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

Pulmonary tuberculosis

Interventions

Experimental group:N-acetylcysteine as an add-on to antituberculosis chemotherapy
Control group:Antituberculosis chemotherapy

Sponsors

Henan Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subject age: >= 18 years, , male or female; 2. Pulmonary tuberculosis patients confirmed by two positive sputum smear results or positive sputum cultures or positive results of Xpert; 3. Sensitivity to rifampicin (confirmed by DST and/or Xpert); 4. Active lesions in the lungs, with or without cavitation, confirmed on chest x-ray; 5. Absence of hemoptysis; 6. Normal liver function prior to treatment (ALT, AST, T-BiL all within normal limits); 7. Absence of chronic respiratory disease (COPD, asthma, etc.); 8. Absence of chronic liver or kidney disease (viral hepatitis, liver tuberculosis, nephritis, etc.); 9. Absence of mental illness or epilepsy; 10. Absence of immunocompromised and immunosuppressive drugs within the last 3 months; 11. Fully understand the purpose and requirements of this test and voluntarily sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients taking other hepatotoxic drugs (overdose of acetaminophen, etc.); 2. Patients with non-tuberculous mycobacteria (NTM) infections; 3. HIV positive patient; 4. Patients with concomitant malignancies; 5. Patients who do not take their medication regularly as planned or who do not complete their course of treatment; 6. Patients who forced discontinuation due to allergy or adverse reactions (hepatic impairment, etc.); 7. Lost to follow-up.

Design outcomes

Primary

MeasureTime frame
Negative conversion rate of bacteria;QB-Spot;Radiological indicators (X-ray, CT);Body immune state;Treatment failure condition;Recurrent condition;Acquired drug resistance (ADR) situation;Drug induced liver injury (DILI);Liver function index;

Countries

China

Contacts

Public ContactHu Xu

Henan Chest Hospital

19850040@163.com+86 18003811014

Outcome results

None listed

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