The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
Trial Parameters
Brief Summary
This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of primary nephrotic syndrome (PNS) in children.
Eligibility Criteria
Inclusion Criteria: * Age from 1.5 to 18 years; * According to the Evidence-based Guideline for Diagnosis and Treatment of Hormone-sensitive, Relapsed/dependent Nephrotic Syndrome in Children (2016), children diagnosed with PNS; * At enrollment, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2； * At enrollment, serum albumin level below 30g/L, and morning urine protein is 4+ or urinary albumin/creatinine ratio (ACR)≥2.0g/g; * Volunteered to participate in this study and signed informed consent. For children less than 8 years, legal guardians need to sign the informed consent. Exclusion Criteria: * Children who were diagnosed as steroid-resistant NS; * Patients who received Prednisone, other corticosteroids (like Prednisolone, Methylprednisolone), or immunosuppressants (Tacrolimus, Mycophenolate Mofetil, Cyclosporine A, Rituximab, Cyclophosphamide) within 3 months before enrollment; * Secondary NS caused by lupus nephritis, hepatitis B associated nephritis, purpura nephritis,