Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules (NCT04623866) | Clinical Trial Compass
UnknownEarly Phase 1
Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
China10 participantsStarted 2020-11-01
Plain-language summary
About 20% children with allergic purpura develop nephritis syndrome or nephrotic syndrome, 1% to 7% to kidney failure or end-stage renal disease. Children with serious damage to health, significantly reduced quality of life and caused heavy economic burden to the family . As the pathogenesis of HSPN is complex, it is difficult to formulate an exact individualized treatment plan.
Who can participate
Age range6 Years – 14 Years
SexALL
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Inclusion criteria
✓. For children diagnosed with purpura nephritis, the diagnostic criteria for purpura nephritis shall refer to the 2016 edition of Evidence-based Guideline for diagnosis and Treatment of Purpura Nephritis published by the Nephrology Group of The Chinese Medical Association Pediatrics Branch, specifically as follows: Hematuria and/or proteinuria occur within 6 months of the course of allergic purpura. The diagnostic criteria for hematuria and proteinuria are as follows: A. Hematuria: gross hematuria or ≥3 RBC/high-power field (HP) under 3 times of microscope within 1 week. B. Proteinuria: if meeting any of the following conditions: 3 routine urine tests within 1 week qualitatively indicate positive urine protein; 24h quantitative urine protein \>150 mg or urine protein/creatinine (mg/mg)\>0.2; Urinary microalbumin was higher than normal for 3 times within 1 week. Very few children in the acute course of allergic purpura 6 months later, recurrent purpura, hematuria and/or proteinuria for the first time, should be sought for renal biopsy, such as IgA mesangial mesangial proliferative glomerulonephritis, can still be diagnosed as purpura nephritis.
✓. 24-hour urinary protein quantification of 0.5 to 1.0g/1.73m2, and the total amount does not exceed 1.0g (to be quantified in non-infectious conditions);
✓. Age: 6-14 years old;
✓. Normal renal function: eGFR≥90ml/min/1.73m2;
✓. Other manifestations of allergic purpura: skin purpura, abdominal pain, blood stool and joint swelling and pain have been relieved, and the use of hormone or immunosuppressive agents has been stopped for 2 weeks.
✕. Serious diseases of the heart, liver and other important organs, as well as diseases of the blood and endocrine system;
✕. Patients who are known to be allergic to any component of Locust and wolfberry yellow or ACEI/ARB;
✕. Patients who have participated in other clinical trials within three months before enrollment;
✕. The investigator judged that the patient was not fit to participate in the study;(7) renal purpura nephritis wear results indicate Ⅲ magnitude or hints chronic purpura nephritis.