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Clinical Trials/CTRI/2011/09/002023
CTRI/2011/09/002023CompletedPhase 4

Treatment of Early Neuropathy in Leprosy (TENLEP).Trial 2-randomized, double- blind,placebo-controlled trial to determine whether steroid treatment of 32 weeks duration is more effective than treatment with 20 week duration in restoring nerve function in patients with clinical neuropathy and or motor NFI of recent onset (less than 6 months) - TENLEP

Royal Tropical Institute KIT0 sites655 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
655

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

Sponsor
Royal Tropical Institute KIT

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