Combination of two drugs in tuberculosis treatment
- Conditions
- New sputum positive patients
- Registration Number
- CTRI/2015/01/005475
- Lead Sponsor
- Department of Pulmonary Medicine
- Brief Summary
Rifampicin containing fixed-dosecombinations are the currently approved treatments against TB in India and worldover. Rifampicin is a potent drug to fight TB but it has some unpleasantside-effects that often forces the patients discontinue with the medicine. Risorineis a combination of currently used antitubercular drugs isoniazid andrifampicin mixed with a new ingredient piperine (an extract of black pepper). Thecombination tablet uses only 200 mg of rifampicin instead of 450 mg, butmaintains the same efficacy and therefore reduces the need for high doses. However there is lack of evidence for Risorine in south Indian population. The present study will be an evidence based report.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Patient who is willing to give informed consent and sputum positive patient.
Pregnant and lactating women and Patient who is unwilling to participate in the trial.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sputum conversion rate, improvement in lung function, chest x ray one year
- Secondary Outcome Measures
Name Time Method Improvement in QoL and cognitive function 6 months
Trial Locations
- Locations (1)
Department of Pulmonary Medicine
🇮🇳Kancheepuram, TAMIL NADU, India
Department of Pulmonary Medicine🇮🇳Kancheepuram, TAMIL NADU, IndiaDr AD NageswariPrincipal investigator9940044571dradnageswari@yahoo.com