Evaluation of hepatoprotective effect of picroliv in patients receiving multi drug therapy of tuberculosis.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Tuberculosis, Drug induced liver injury
- Registration Number
- CTRI/2012/08/002850
- Lead Sponsor
- CSIR Central Drug research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 260
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To detect the number of patients who develop hepatotoxicity in each groupTimepoint: 0, 2week, 1,2,3,4,5,6 month
- Secondary Outcome Measures
Name Time Method 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