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A study to compare effectiveness, safety and benefit of methotrexate versus thalidomide as an alternative to steroid in treatment of erythema nodusum leprosum patients in a tertiary care hospital

An institution based comparative study evaluating the efficacy, tolerability and net benefit of methotrexate versus thalidomide as a corticosteroid sparing agent in treatment of erythema nodusum leprosum patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089639
Enrollment
70
Registered
2025-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Methotrexate and folic acid once in a week and Prednisolone daily: 1st week: Methotrexate and folic acid 5mg, Prednisolone 40 mg. 2nd week: Methotrexate and folic acid 10mg, Prednisolon

Sponsors

Bankura Sammilani Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving consent and clinically diagnosed cases of severe erythema nodosum leprosum value of ENLIST ENL severity scale is more than 8. Alcohol intake below national guideline. Patients unwilling to seek child birth and ready to follow at least 2 reliable contraceptive.

Exclusion criteria

Exclusion criteria: Pregnant and Lactating women. Patients with hypersensitivity to methotrexate or thalidomide or corticosteroid. Patients with contraindication to methotrexate or thalidomide or corticosteroid. Critically ill patients. Patients not on any of the following drugs: Immunosuppressant, pentoxifylline, chloroquine, colchicine or drugs known to interact with methotrexate or thalidomide or corticosteroid

Design outcomes

Primary

MeasureTime frame
Efficacy of methotrexate and thalidomide towards onset of dose tapering and maintenance of discontinuation of systemic corticosteroid. Relapse rate of ENL treated with methotrexate and thalidomide. Timepoint: Weekly monitoring for total 48 weeks period.

Secondary

MeasureTime frame
Adverse effects of methotrexate and thalidomide. Net benefits of treatment using methotrexate and thalidomide for the patients.Timepoint: Weekly monitoring for total 48 weeks period.

Countries

India

Contacts

Public ContactArghyaprasun Ghosh

Bankura Sammilani Medical College

arghyap_ghosh@yahoo.com09432443277

Outcome results

None listed

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