CTRI/2011/09/002022RecruitingPhase 4
Treatment of Early Neuropathy in Leprosy (TENLEP). Trial 1-randomized , double-blind, placebo -controlled trial to determine whether steroid treatment of early sub clinical nerve function impairment (NFI) would benefit patients in terms of the prevention of clinical sensory or motor function impairment. - TENLEP
Royal Tropical Institute KIT0 sites790 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 790
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •All newly detected leprosy patients
Exclusion Criteria
- •1) Any leprosy patient with single lesion on the trunk as the only sign of leprosy
- •2) Any patient over 60 or under 15 on the basis of legal document
- •3) Women with known pregnancy at the time of diagnosis
- •4) People with known other conditions that may affect the peripheral nervous system (e.g. diabetes, alcohol abuse, HIV/Aids, carpel tunnel syndrome , nerve injuries) through specific history talking DM test, PICT for HIV, liver function tests.
- •5) Any patient refusing informed consent.
- •6) Any patient for whom full dose of steroid would be indicated for reasons other than recent nerve function impairment.
Investigators
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