Prevention of hepatotoxicity due to anti tuberculosis treatment: A novel integrative approach

Table 1 Protocol for selection of patients for recruitment

Protocol for selection of patients for recruitment
Criteria for selection
Evidence of active pulmonary or extra-pulmonary tuberculosis
Age between 15 and 85 years
Readiness to comply with randomization, treatment and follow-up protocols
Patients giving written informed consent
Absence of diseases warranting treatment with systemic steroids, antimetabolites or warfarin
Concomitant conditions allowed
Patients with relapse, multiple relapse, treatment failure of DOTS regimen
Patients with hypertension, diabetes mellitus, COPD (chronic obstructive pulmonary disease) with continuation of required medications
Patients with asthma on inhalational steroid
Skin conditions requiring topical small area steroid application
Patients with HIV positivity but without symptoms suggestive of AIDS
Hepatitis B/C virus carrier
Criteria for rejection
Presumptive diagnosis or lack of evidence of active tuberculosis
Age < 15 or > 85
Patients taking other alternative therapies for tuberculosis
Patients declining to give consent or comply with protocol
Pregnant females
Heavy alcoholism history, > 80 g of alcohol/d for males and > 20 g of alcohol/d for females[50]
Concomitant conditions not allowed
Preexisting liver disease with AST, ALT raised > twice upper normal, evidence of portal hypertension.
Preexisting renal disease with S. Creatinine raised > twice upper normal
Sickle cell disease with history of crisis, anemia and jaundice
History of gout
Recent drop-outs from other TB centers due to complications and side effects
Patients on steroid and/or antimetabolite for other collagen, auto-immune or neoplastic diseases