Health Condition 1: null- Leprosy
Conditions
Interventions
Intervention1: ROM
: Single dose of rifampicin (600 mg), ofloxacin (400 mg) and minocycline (100 mg)
Control Intervention1: WHO-PB-MDT: Rifampicin (600mg) once a month and dapsone (100mg) daily for
Sponsors
WHO
Eligibility
Inclusion criteria
Inclusion criteria: PB leprosy patients with two to five lesions, who were untreated, smear-negative and who did not have more than one peripheral nerve trunk involvement.
Exclusion criteria
Exclusion criteria: Children below five years of age, those with reversal reaction and / or neuritis requiring treatment with corticosteriods, those who were pregnant at the time of intake, those known to be allergic to any of the proposed drugs or their derivatives and those who were HIV positive (if tested) at intake.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome was clinical improvement. We defined efficacy if there was complete disappearance of all lesions. We also assessed each patient clinically and a clinical score was given based on defined criteria and any decline from the base-line was also considered as improvement.Timepoint: Every six months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| RelapseTimepoint: Every six months post-treatment | — |
Countries
India
Contacts
Public ContactProf MD Gupte
National Institute of Epidemiology
Outcome results
None listed