Health Condition 1: A303- Borderline leprosy
Conditions
Interventions
Intervention1: Clofazimine: In Borderline Lepromatous and Lepromatous Leprosy (BL/LL) patients on Multibacillary Multidrug Therapy (MBMDT) or within 12 months of Release from Treatment (RFT), who have
Sponsors
Leprosy Research Initiative
Eligibility
Inclusion criteria
Inclusion criteria: 1) Smear positives cases, i.e. smear positive at diagnosis within 24 months of starting Multibacillary Multidrug Therapy (MBMDT)(as new case, returned defaulter or relapse), i.e. on 12 m fixed duration MBMDT or within 12m of completion of 12m Fixed Duration (FDMBMDT) or on 24m FDMBMDT. 2) People who have or previously had ENL, ENL as defined in ENLIST publications, at any time in past, confirmed by Doctor (physical exam or clinic records), or currently. 3) 1st episode of ENL or recurrent episode (after interval without treatment of >27 days), i.e. exclude chronic ENL (symptoms of ENL and /or treatment for ENL for 24 weeks or more without any interval of >27days) 4) over 18 years old up to 60 years 5)minimum weight 40 kg or BMI >18.5
Exclusion criteria
Exclusion criteria: 1)Type 1 reaction, i.e. currently (may occur in BB, BL cases) A past history of type one reaction already fully treated and resolved would not exclude case. 2)Cannot understand about study or lives too far away to attend regularly for follow up, i.e. unable to give truly informed voluntary consent or to cooperate with all assessments 3) Chronic bowel disorder, (e.g. chronic amebic dysentery, ulcerative colitis, irritable bowel syndrome, suspected intestinal TB, malabsorption syndrome etc). 4) Other serious illness likely to interfere with safety or compliance, e.g. HIV, chronic moderate/severe renal impairment, Tb, cancer, uncontrolled type 1 diabetes. 5) Serious adverse effects of steroids in past such as standard regimen in field would not be safe (e.g. GI haemorrhage, glaucoma, steroid-induced psychosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m, 2. to compare the proportion who have recurrence and severity and of ENL over 24 months observation, in those who receive additional clofazimine (at least 100mg/day for 6-12m) with that in those who receive only clofazimine at 50mg /day (or none if RFT). Timepoint: 12,24,36,48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare proportion with increased nerve function impairment in same two groups. 2. To compare the change in health-related quality of life in same two groups. Timepoint: 12,24,36,48 months | — |
Countries
Bangladesh, India
Contacts
Public ContactMr Rahul Kumar Gupta
Bombay Leprosy Project
Outcome results
None listed