Health Condition 1: null- Type 2 Lepra reaction occuring in patients suffering from Leprosy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult patients above 18 years of age presenting with type 2 lepra reaction 2. patients giving informed written consent
Exclusion criteria
Exclusion criteria: 1. Patient under 18 yrs. 2. Patient not giving informed written consent 3. Patients suffering from cardiac, hepatic, renal, neurological diseases, bleeding disorder, mental diseases, diabetes and/or immune-deficiencies related to HIV or not. 4. Patients having any or history ofcerebrovascular disease 5. Patients having history of hypersensitivity to methyl xanthine derivatives or Clofazimine. 6. patients showing abnormal baseline laboratory parameters 7. patients manifesting significant adverse effect of any drugs warranting discontinuation of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days required for complete remission of skin lesions in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Days required for complete remission of systemic symptoms in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks;Laboratory safety parameters (Routine haemogram, LFT, Serum urea, creatinine, fasting blood glucoseTimepoint: 0, 12 weeks;Number and Interval of relapse (if any) in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks;Spontaneously reported and clinically elicited side effectsTimepoint: 1, 2, 4, 6, 8, 10, 12 weeks | — |
Countries
India
Contacts
Medical College, Kolkata