Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention1: METHOTREXATE: The intervention arm will receive methotrexate tablet starting from 0.15mg/kg/week for 2 weeks, then 0.3mg/kg/week for 2 weeks, then tapered to 5mg/week over 2 months, to
Sponsors
Professor Jayantee Kalita
Eligibility
Inclusion criteria
Inclusion criteria: Patients with leprosy neuropathy within one year of symptoms will be recruited. The diagnosis of leprosy will be confirmed by characteristic clinical (hypopigmented anaesthetic patch, infiltrative lesion, thickened nerve, mononeuropathy or mononeuropathy multiplex.
Exclusion criteria
Exclusion criteria: Patients with Interstitial lung disease, vasculitis, rheumatoid arthritis, organ failure (Liver, kidney, heart), malignancy, pregnancy, lactating mothers, likely to be pregnant within a year, history of allergy to Mtx and organ transplant will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportions of the patients with restored or improved nerve functions in composite score. Restored- All nerves functions are normal Improved- 3 points improvement in monofilament and 1 point improvement in MRC scale Deteriorated- Deterioration in 3 points in monofilament and 1 point in MRC scale. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with leprosy reaction using standard criteria. 2. Improvement in neuropathic scale 3. Improvement in SALSA scale 4. Proportion of patients with SAE 5. Proportion of patients needing adjunctive immunosuppression. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactProfessor Jayantee Kalita
Sanjay Gandhi Post Graduate Institute of medical Sciences
Outcome results
None listed