The Effect of Curcumin on the Clinical Outcome of Pediatric Patients With Active Lupus Nephritis
Lupus Nephritis, SLE Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring curcumin, herbal medicine, lupus nephritis, paediatric onset SLE
Eligibility Criteria
Inclusion Criteria: 1- Lupus nephritis patients both genders aged 16 or younger 2- Biopsy specimens confirmed active lesions or active and chronic lesions defined as nephritis according to WHO classification 3- Children on standard treatment (mycophenolate mofetil + hydroxychloroquine + steroids) 4- Children on another standard regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids Exclusion Criteria: Dialysis or B cell-targeted therapy (including belimumab) within the preceding year Patients with other comorbidities Smokers Previous failures of both MMF and CYC induction therapy, Estimated glomerular filtration rate (eGFR) of less than 30 ml/min per 1.73 m2 of body surface area.
Sites / Locations
- Outpatients Clinic of Pediatric Rheumatology department - Children's Hospital, Ain Shams University, Cairo, Egypt.Recruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
standard of care
Curcumin Oral Capsule group
patients will receive oral MMF initial dose of 1200 mg/m2/day, no more than 2000 mg/day, increased to 1800 mg/m2/day, no more than 3000 mg/day, if response is not good + corticosteroid protocols are: intravenous pulse of methylprednisolone (30 mg/kg/dose for three consecutive days, no more than de 1000 mg/dose), followed by oral prednisolone/prednisone (0.5-1.0 mg/kg/day); or high dosage oral prednisone/prednisolone (1-2 mg/kg/day, no more than 60 mg/day) + hydroxychloroquine 4.0-5.5 mg/kg/day second regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids
patients will receive oral 1000 mg of curcumin capsules daily in addition to their standard treatment for three months. Standard treatment includes: oral MMF initial dose of 1200 mg/m2/day, no more than 2000 m g/day, increased to 1800 mg/m2/day, no more than 3000 mg/day, if response is not good + corticosteroid protocols are: intravenous pulse of methylprednisolone (30 mg/kg/dose for three consecutive days, no more than de 1000 mg/dose), followed by oral prednisolone/prednisone (0.5-1.0 mg/kg/day); or high dosage oral prednisone/prednisolone (1-2 mg/kg/day, no more than 60 mg/day) + hydroxychloroquine 4.0-5.5 mg/kg/day second regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids