Health Condition 1: A309- Leprosy, unspecified
Conditions
Interventions
Intervention1: Thalidomide,Azathioprine,Prednisolone: Group 1: The patients will receive prednisolone 1mg/kg/day or a maximum dose of 60mg at baseline along with thalidomide 100mg four times daily for
Sponsors
Deepak Kumar Sahu
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients with severe ENL of any gender and age >18 years. ii. Patients willing to participate and willing to follow up for nine months
Exclusion criteria
Exclusion criteria: i. Patients with known immunosuppression ii. Patients with severe ENL on any steroid-sparing agents within the last one month iii. Pregnancy and lactation iv. Patients with a history of hypersensitivity to thalidomide or azathioprine v. Patients with hemoglobin less than 10 gm/dl vi. Patients with HIV, Hepatitis B and C infection. vii. Patients who will deny giving consent to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving remission at six month and nine months (Remission is defined as subsidence of all features of ENL with ENL International Study Group Severity Scale score of zero when the patient is off prednisolone or minimal prednisolone dose of 10mg or less)Timepoint: six month and nine months | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative dose of prednisoloneTimepoint: nine months; Number of ENL flaresTimepoint: Nine months;Time to initial remissionTimepoint: within nine months;Time to ENL flareTimepoint: within nine months;The correlation between EESS( ENLIST ENL Severity Score) and serum interferon-gamma levels NB: Optional subject to thesis grant approveTimepoint: nine months;Side effect profiles (frequency, nature and severity)Timepoint: within nine months;Change in DLQI from the baselineTimepoint: end of nine month;Pathological differences between acute versus chronic/recurrent ENLTimepoint: nine months | — |
Countries
India
Contacts
Public ContactDeepak Kumar Sahu
Chief guide
Outcome results
None listed