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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huaiqihuang Group | Active Comparator | Huaiqihuang granules 60g/1.73m2 bid 24 weeks |
|
| Valsartan group | Active Comparator | Valsartan granules 80mg/1.73m2 based qd 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaiqinhuang | Drug | Huaiqihuang granules are composed of Huaier fungus, Fructus lycii and Huangjing. Studies have shown that huaiqihuang treatment can reduce cytokines in children with purpura nephritis interleukins IL - 4, IL - 10 and the tumor necrosis factor alpha (TNF alpha) expression level, prompt huaiqihuang granule treating children allergic purpura nephritis can significantly improve the clinical curative effect, improve the level of cytokines and the patient's immune function, and does not increase the incidence of adverse reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| change of urinary protein | 24-hour urinary protein quantitative, urinary microprotein | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| Change in renal function of the patients | blood chemistry | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| change of lymphocyte subsets | including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.) | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| change of immunoglobulin + complement | immunoglobulin + complement | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| change of urine red blood cells | red blood cells routine urine | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change of blood pressure | blood pressure | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| change of BMI(Body Mass Index) | calculated by dividing weight in kilograms by height in meters squared( kg/m^2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mao Jianhua | Contact | 13516819071 | maojh88@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Mao Jianhua | The Children's Hospital of Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China | ||
We could not share data without patients' agreement
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| valsartan | Drug | Valsartan granules 80mg/1.73m2 based qd 24 weeks |
|
|
| before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |
| Children's Hospital, Zhejiang University School of Medicine |
| Hangzhou |
| Zhejiang |
| China |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |