Erythema Nodosum Leprosum | Montelukast in ENL Reaction
Erythema Nodosum Leprosum research study
What is the primary objective of this study?
Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in combination with prednisolone or alone. Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary leprosy patients without causing an unacceptably high incidence of adverse effects. Design is a multicentre hospital-based single-blind prospective trial for leprosy patients with ENL reaction. prior written consent will be taken from the patients who will undergo the trial. Endpoints are decrease in severity of ENL and absence of new nerve function impairment
Who is eligible to participate?
Inclusion Criteria: - MB leprosy - ENL reaction - age 15-65 - weight >35kg - patient willing to participate,including agrees to investigations and admission - adequate past records - no steroid received in past 4 weeks Exclusion Criteria: - pregnant or breast feeding - other active serious infection - history of intolerance to concerned drug - known or suspected immunodeficiency - needs high dose steroid for other condition - recent new nerve funcion impairment - recent hepatitis or impaired liver function - thrombocytopenia, moderate or severe renal impairment - received high dose clofazimine in past 3 months
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Erythema Nodosum Leprosum
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:montelukast in treatment of ENL reaction
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 2006
Completed Date: June 2009
Primary Outcome: decrease in ENL score
Study sponsors, principal investigator, and references
Principal Investigator: Abdul H Salim, MBBS
Lead Sponsor: The Leprosy Mission Bangladesh