Drug Induced Liver Injury, Tuberculosis (TB)
Conditions
Keywords
prevention of Antituberculous drugs induced liver injury
Brief summary
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
DRUGSilymarin 420 mg
silymarin group received silymarin 140mg thrice daily along with antituberculous drugs for 14 days
N- acetylcysteine group will receive N-acetylcysteine 900mg once daily with antituberculous drugs for 14 days
Antituberculous drugs only
Sponsors
Liaquat National Hospital & Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Tuberculous Drug induced Hepatotoxicity | 14 days | Outcome will be assessed in patients developing Anti-tuberculous Drug-Induced Hepatotoxicity. Patients diagnosed with TB and started on a regimen based on isoniazid, rifampicin, pyrazinamide, and ethambutol will be labeled as having Anti-tuberculous Drug-Induced Hepatotoxicity using liver function tests. It will be labeled if any one of the following criteria is met: * Rise in alanine aminotransferase (ALT) more than or equal to a fivefold increase from the upper limit of normal (\>37 IU/L) * Rise in alkaline phosphatase (ALP) more than or equal to twofold increase from the upper limit of normal (\>147 IU/L). * An increase in alanine aminotransferase (ALT) to three or more times the upper normal limit (greater than 37 IU/L), accompanied by a simultaneous rise in bilirubin levels to more than twice the upper normal limit (exceeding 1.5 mg/dL), will be considered significant. |
Contacts
Primary ContactAriba Sultan, MBBS
Backup Contactshameem behram khan, fcps
Outcome results
None listed