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Not yet recruiting NCT07058090

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

Phase I Interventional Drug Induced Liver Injury Tuberculosis (TB)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silymarin 420 mg, N Acetyl Cysteine, Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z).
Who it may be relevant to
Registry conditions: Drug Induced Liver Injury, Tuberculosis (TB). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Silymarin 420 mg
    silymarin group received silymarin 140mg thrice daily along with antituberculous drugs for 14 days
  • Drug N Acetyl Cysteine
    N- acetylcysteine group will receive N-acetylcysteine 900mg once daily with antituberculous drugs for 14 days
  • Drug Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
    Antituberculous drugs only

Primary outcome measures

  • Anti-Tuberculous Drug induced Hepatotoxicity [Time frame: 14 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ejigu DA, Abay SM. N-Acetyl Cysteine as an Adjunct in the Treatment of Tuberculosis. Tuberc Res Treat. 2020 Apr 30;2020:5907839. doi: 10.1155/2020/5907839. eCollection 2020. PMID 32411461
  • Safe IP, Lacerda MVG, Printes VS, Praia Marins AF, Rebelo Rabelo AL, Costa AA, Tavares MA, Jesus JS, Souza AB, Beraldi-Magalhaes F, Neves CP, Monteiro WM, Sampaio VS, Amaral EP, Gomes RS, Andrade BB, Cordeiro-Santos M. Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study). PLoS One. 2020 Jun 26 PMID 32589648
  • Mahakalkar SM, Nagrale D, Gaur S, Urade C, Murhar B, Turankar A. N-acetylcysteine as an add-on to Directly Observed Therapy Short-I therapy in fresh pulmonary tuberculosis patients: A randomized, placebo-controlled, double-blinded study. Perspect Clin Res. 2017 Jul-Sep;8(3):132-136. doi: 10.4103/2229-3485.210450. PMID 28828308
  • Luangchosiri C, Thakkinstian A, Chitphuk S, Stitchantrakul W, Petraksa S, Sobhonslidsuk A. A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury. BMC Complement Altern Med. 2015 Sep 23;15:334. doi: 10.1186/s12906-015-0861-7. PMID 26400476

Identifiers

NCT: NCT07058090 · 1188-2025-LNH-ERC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗