Leprosy
Conditions
Brief summary
Erythema nodosum leprosum (ENL) is characterized by painful nodules and systemic compromising. It is usually recurrent and/or chronic and has both physical and economic impact on the patient, being a very important cause of morbidity and mortality. In addition, ENL is a major health problem in developing countries like Bangladesh where leprosy is endemic. Therefore, adequate control of this condition is important to reduce morbidity and mortality. The treatment of ENL is usually started with steroids which have many adverse effects when given for prolonged periods and in high doses. However, recently in some case reports MTX appears to have a beneficial effect in cases of ENL. Also, MTX may provide a cheaper and convenient option in management of ENL. However, there is paucity of well-designed randomized controlled trial on the effectiveness of MTX in the treatment of ENL. In this context such studies are needed. The investigator therefore designed this randomize trial to evaluate the efficacy and safety of combined MTX and Prednisolone over Prednisolone monotherapy in local setting. The investigator combined reducing doses of Prednisolone with a low dose MTX to minimize dose related complications, while maximizing benefit in controlling ENL. If the study results would show the superiority of combined regimen as found elsewhere in the World, it would be helpful to reduce the morbidity of ENL Patients.
Interventions
DRUGEfficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
For Group A: Each of the selected patients of group A received Tablet Methotrexate 2.5 mg 3 doses (12 hour apart), 7.5mg per week for 6 months and Tablet Prednisolone (40mg/day) tapering over 3 months. Reducing 5 mg of prednisolone every 2 weekly up to 20 mg/day then 5 mg every week for 1 month. And Methotrexate was used 7.5 mg weekly as maintenance dose. For Group B: Patients of group B received Prednisolone (40mg/day) tapering over 6 months. Reducing 5 mg every 2 weeks up to 20 mg (2 months) then 20 mg continued for 10 weeks. Then reduced 5 mg every 2 weeks up to 24 weeks.
Sponsors
Chittagong Medical College
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patient with ENL had crops of tender subcutaneous skin lesions with systemic features including fever (temperature \>38°C), neuritis, joint pain, bone tenderness, orchitis, iritis, oedema, malaise, anorexia and lymphadenopathy. 2. Patients of both sexes with age ranging 18 years to 65 years.
Exclusion criteria
1. Erythema nodosum associated with other disorder. 2. Pregnant and lactating women. 3. Diagnosed case of chronic hepatic, renal, hematological or other connective tissue disorders, Osteoporosis. 4. Severely ill, immune-suppressed patients like HIV/AIDS and patients of internal malignancy. 5. Patients or guardians not willing to participate in the study by signing informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) | 01.06.2018 to 31.12.2019 total 18 months | Primary outcome: Improvement in Reaction severity assessment score by observing signs and symptoms like tender skin ENL nodules. |
Countries
Bangladesh
Outcome results
None listed