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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorLiaquat National Hospital & Medical College

About this trial

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

Eligibility criteria

Qualifiers

Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age

either gender.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Silymarin 420 mg
  • N Acetyl Cysteine
  • Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Treatment groups

410 Participants
are divided into 3 treatment groups

Locations

This trial has no locations