To find out the usefulness of colchicine in the treatment of leprosy reactio
Not Applicable
- Conditions
- Health Condition 1: A305- Lepromatous leprosy
- Registration Number
- CTRI/2021/05/033765
- Lead Sponsor
- Dr Namrata Chhabra Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 32 weeks <br/ ><br>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. <br/ ><br>Timepoint: At baseline, at 32 weeks
- Secondary Outcome Measures
Name Time Method 1.Change in ENLIST ENL severity scale score at follow up visits <br/ ><br>2.Number and severity of ENL flares during the study period <br/ ><br>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 <br/ ><br>4.Adverse effects: Proportion of individuals with treatment related adverse effects <br/ ><br>5.The cumulative dosage and duration of prednisolone required during the study period <br/ ><br>Timepoint: 32 weeks