Health Condition 1: A305- Lepromatous leprosy
Conditions
Interventions
Intervention1: Colchicine and Prednisolone: Prednisolone scheme will be as per standard protocol of treatment. In addition oral colchicine will be given at dose of 0.5 mg thrice daily for the duration
Sponsors
Dr Namrata Chhabra Sharma
Eligibility
Inclusion criteria
Inclusion criteria: All patients with MB leprosy and older than 18 years with moderate and severe ENL (ENLIST ENL severity score �9) at the time of the OPD visit.
Exclusion criteria
Exclusion criteria: 1. Absolute contraindications for steroids including hypersensitivity to drug or components of formulation, active tuberculosis, systemic fungal infection 2. In group II, absolute contraindications of colchicine, i.e. patients with severe renal or hepatic dysfunction will be excluded 3. Pregnant or breastfeeding women 4. Individuals unable to attend regularly for assessment or monitoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 32 weeks 2. Proportion of individuals who have not required additional prednisolone during the study period. The aim is to evaluate if individuals in the colchicine arm will need less prednisolone than the control arm. Timepoint: At baseline, at 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in ENLIST ENL severity scale score at follow up visits 2. Number and severity of ENL flares during the study period 3. Time to the first flare of ENL: How long it takes to a participant who has an ENL flare to present with first episode of recurrent ENL after enrolment 4. Adverse effects: Proportion of individuals with treatment related adverse effects 5. The cumulative dosage and duration of prednisolone required during the study period Timepoint: 32 weeks | — |
Countries
India
Contacts
Public ContactNamrata Chhabra Sharma
All India Institute of Medical Sciences, Raipur
Outcome results
None listed