niform treatment regimen for all types of leprosy patients
Phase 3
Completed
- Conditions
- Health Condition 1: null- Leprosy
- Registration Number
- CTRI/2012/05/002696
- Lead Sponsor
- WHOTDR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3500
Inclusion Criteria
All the newly detected and treatment-naive leprosy patients will be eligible for inclusion. It is suggested the following categories of patients may be included in the study: easily accessible to the clinic, available for long-term follow-up and for receiving supervised dose of drug.
Exclusion Criteria
Newly detected pure neuritic patients, old patients, who are already receiving PB or MB-MDT, returned defaulters, and those who relapse subsequent to the earlier therapy will not be eligible for inclusion for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess treatment response to 6 monthsâ?? Uniform MDT (UMDT) for all types of leprosy patients in terms of relapse rate not exceeding a maximum acceptable cumulative level of 8% at the end of 8 years <br/ ><br>Timepoint: Every one year post treatment
- Secondary Outcome Measures
Name Time Method To assess acceptability, safety and compliance of UMDTTimepoint: At the end of treatment completion