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EVALUATION OF EFFECTS OF N- ACETYL CYSTEINE ON THE PREVENTION OF LIVER INJURY AND QUALITY OF LIFE IN PATIENTS TAKING TREATMENT FOR TUBERCULOSIS.

A STUDY TO EVALUATE THE HEPATOPROTECTIVE EFFECT OF N - ACETYLCYSTEINE ON ANTI TUBERCULOSIS DRUG INDUCED HEPATOTOXICITY AND QUALITY OF LIFE.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/024995
Enrollment
60
Registered
2020-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: N - acetyl cysteine tablet: In one arm, patients will receive the drug, N-acetyl cysteine in the form of tablets two times daily. Control Intervention1: Placebo tablet: In second arm pa

Sponsors

Dr Deepasree Sukumaran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed with pulmonary or extrapulmonary tuberculosis based on symptoms, radiological features and/or laboratory evidence and requiring first line ATT. 2.LFT values less than or equal to 3 times of the normal reference values (SGOT less than or equal to 105 U/L, SGPT less than or equal to 120 U/L, ALP less than or equal to 390 U/L) and Total bilirubin less than or equal to 2 mg/dl). 3. Subjects who agree to comply with the study procedures

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women. 2.History of hypersensitivity to the study drug. 3.Subjects with history of liver disease, kidney disease, COPD, asthma and HIV. 4.History of chronic smoking or chronic alcoholism. 5.Patients on any concomitant medications known to affect hepatic function within the past 3 months. 6.Patients with any comorbidities that is known to affect the study outcome. 7.Patients with any contraindications to the study medications.

Design outcomes

Primary

MeasureTime frame
1.Comparison of proportion of patients developing DILI between treatment and control groups. (DILI defined as per ATS criteria). 2.Change in oxidative stress markers (Malondialdehyde, Nitric oxide and total glutathione levels) from baseline.Timepoint: 0 weeks, 2 weeks, 4 weeks, 8 weeks.—

Secondary

MeasureTime frame
1.Comparison of the quality of life between treatment and control group using SF â?? 12 questionnaire. 2.Comparison of time to development of DILI between treatment and control groups. 3.Incidence of adverse effects in the study population.Timepoint: 0 weeks, 2 weeks, 4 weeks, 8 weeks.—

Countries

India

Contacts

Public ContactDr Deepasree Sukumaran

Nizams institute of medical sciences

ushapingali@yahoo.com9849574143

Outcome results

None listed

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