Health Condition 1: null- Tuberculosis, Drug induced liver injury
Conditions
Interventions
Intervention1: Drug Picroliv + antitubercular Drug Therapy: Dose of Picroliv 100mg twice daily for six months.
Route of administration oral
dose and duration of antitubercular drugs are as per Revised
Sponsors
CSIR Central Drug research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients over the age of 16 years. 2 Willing to give informed consent and comply with protocol requirements and follow up. 3 Diagnosed as Category I, II or III tuberculosis of the RNTCP (Revised National Tuberculosis Control Program). 4 Receiving treatment with at least 3 anti tubercular drugs or as per the RNTCP guidelines.
Exclusion criteria
Exclusion criteria: 1 Unwilling to comply with protocol requirements and duration of follow up. 2 History of jaundice in the past 6 months. 3 History of having received any drug from the non allopathic systems of medicine in the past 3 months. 4 Pregnancy. 5 Severe hepatic, renal or cardiac disease. Lactation. 6 H/o consuming alcohol daily.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To detect the number of patients who develop hepatotoxicity in each groupTimepoint: 0, 2week, 1,2,3,4,5,6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed by laboratory, clinical findings and the number of patients who develop adverse events other than hepatotoxicity in each group and compared.Timepoint: 0, 2week, 1,2,3,4,5,6 month | — |
Countries
India
Contacts
Public ContactDr Vivek Bhosale
CSIR-Central Drug research Institute, lucknow
Outcome results
None listed