Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
- Conditions
- Henoch Schönlein Purpura Nephritis
- Interventions
- Drug: Huaiqinhuang
- Registration Number
- NCT04623866
- Lead Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Huaiqihuang Group Huaiqinhuang Huaiqihuang granules 60g/1.73m2 bid 24 weeks Valsartan group valsartan Valsartan granules 80mg/1.73m2 based qd 24 weeks
- Primary Outcome Measures
Name Time Method change of urine red blood cells before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization red blood cells routine urine
change of urinary protein before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization 24-hour urinary protein quantitative, urinary microprotein
Change in renal function of the patients before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization blood chemistry
change of lymphocyte subsets before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.)
change of immunoglobulin + complement before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization immunoglobulin + complement
- Secondary Outcome Measures
Name Time Method Change of blood pressure before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization blood pressure
change of BMI(Body Mass Index) before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization calculated by dividing weight in kilograms by height in meters squared( kg/m\^2)
Trial Locations
- Locations (2)
The Children Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Children's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China