The Effect of Curcumin on the Clinical Outcome of Pediatric Patients With Active Lupus Nephritis
Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
Pediatric Lupus nephritis which is a sever and common complication to childhood onset
systemic lupus erythematous is an aggressive inflammatory process triggered by the deposition
of antigen-antibody complex in kidney tissue. The complex stimulates production of multiple
immune cells, activating Inflammasome NLRP3 that plays massive role in stimulating various
cytokines like IL-6. The inflammation also causes elevation in proteinuria and serum
creatinine levels beside other inflammatory markers elevation (CRP )and (ESR). These children
are treated with a standard regimen consists of an immunomodulator (mycophenolate mofetil)
with strong steroid anti-inflammatory and also hydroxychloroquine is added to the regimen to
decrease the intensity of the flares and management of arthritis symptoms. In our study we
are introducing a powerful antioxidant and anti-inflammatory drug with nephroprotective
benefits which is curcumin capsules. The drug showed success in managing different autoimmune
and inflammatory diseases as rheumatoid arthritis and Crohn's disease, it also showed
dramatic improvement in lupus nephritis models in previous experimental study. The study
primary outcome is will be the composite of the effect of curcumin on Urine
protein-to-creatinine ratio and NLPR3 Inflammasome levels in blood. Patients meeting the
study inclusion criteria will be educated firmly about the disease details and all
information about the drug, then will be randomly assigned to one of two groups, the first
group receiving the standard therapy only while the second one receiving the standard therapy
beside the curcumin 1000 mg capsules orally daily, a third small group of healthy children as
a control for normal inflammasome levels. Patients in the first two groups will undergo
baseline evaluation at the beginning of the study including Patients' demographic data,
anthropometric measures and medication history. Moreover, collecting patients' medical
history which includes Duration of systemic lupus, Duration of lupus nephritis, other organs
involvement, past and current medical condition or prescribed and OTC medications. Laboratory
Evaluation and renal function assessment will include Inflammasome levels in blood using
ELISA technique using Human NLRP3 ELISA Kit, Serum creatinine levels, Protein in urine
levels, estimated glomerular filtration rate (eGFR) using Original Schwartz Equations,
Inflammatory biomarkers (ESR, CRP), anti-ds DNA, anti-ANA DNA and evaluating Hematuria.
Baseline Clinical evaluation includes Blood pressure measurement and Kidney structural damage
evaluation via biopsy. Then patients will be followed up monthly for three months for
assessing Patient Compliance with the prescribed medication regimens and the study drug,
Occurrence of side effect graded using monitoring of side effects scale (MOSES) and checking
for Allergic reactions against the drug. After the three months, all patients will be
reassessed for all laboratory and clinical evaluations. finally results will be statistically
analyzed Statistical analysis will be done using SPSS statistical software package