Treatment of Early Neuropathy in Leprosy

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/002023

Enrollment

655

Registered

2011-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A309- Leprosy, unspecified Health Condition 2: null- New confirmed cases of leprosy

Interventions

Intervention1: Corticosteroids: Trial 2 ? Two parallel arms with corticosteroids (1mg/kg body weight OD) given orally, one arm for 20 weeks + 12 weeks of placebo and other arm for 32 weeks Corticoster

Eligibility

Inclusion criteria

Inclusion criteria: All newly detected leprosy patients

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Trial 2:Using univariate analysis 1) recovered nerve function 2) improved nerve function 3) deteriorated nerve function 3) recovered Salsa and P scale 4) improved salsa and P scale 5) deteriorated salsa and P scale 6) proportion requiring additional steroids at the end of 18 months.Timepoint: 32 weeks and at 12 and 18 months from start of treatment.	—

Secondary

Measure	Time frame
1) Cumulative incidence of additional sub-clinical NFI assessed by nerve conduction or thermal sensation testing 2) Spontaneous recovery of nerve function assessed by nerve conduction or thermal sensation testing 3) Patients / nerves that did not change at the end of treatment i.e. 32weeks and at 12 and 18 months from start of treatment. Timepoint: 32 weeks and at 12 and 18 months from start of treatment.	—

Measure

Time frame

1) Cumulative incidence of additional sub-clinical NFI assessed by nerve conduction or thermal sensation testing 2) Spontaneous recovery of nerve function assessed by nerve conduction or thermal sensation testing 3) Patients / nerves that did not change at the end of treatment i.e. 32weeks and at 12 and 18 months from start of treatment. Timepoint: 32 weeks and at 12 and 18 months from start of treatment.

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Countries

Bangladesh, India, Indonesia, Nepal

Contacts

Public ContactDr Nerges F Mistry

The Foundation for Medical Research

fmr@fmrindia.org02224934989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026