NCT04623866Unknown早期 1 期

A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules

The Children's Hospital of Zhejiang University School of Medicine2 个研究点分布在 1 个国家目标入组 10 人开始时间: 2020年11月1日最近更新: 2020年11月10日

适应症

干预措施

试验速览

阶段: 早期 1 期
发起方
入组人数: 10
试验地点: 2
主要终点: change of immunoglobulin + complement

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Children of Purpura nephritis with moderate protenuria(24 hours urinary protein quantitative 0.5 ~ 1.0 1.73 g/m2 and 24 hours urinary protein amount of not more than 1.0 g) in this study was choosed as participatant, plan randomly into the group of 10 cases, treated with huaiqihuang particles and valsartan for 24 weeks to analyze the curative effect and clinical value of single drug therapy for children with purpura nephritis in reducing proteinuria, protecting renal function and promoting rehabilitation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围: 6 Years 至 14 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Abnormal ophthalmic examination (fundus, visual field, photosensitivity);
•Combined with gross hematuria;
•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.

研究组 & 干预措施

Huaiqihuang Group

Active Comparator

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

干预措施: Huaiqinhuang (Drug)

Valsartan group

Active Comparator

Valsartan granules 80mg/1.73m2 based qd 24 weeks

干预措施: valsartan (Drug)