Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules

NCT ID: NCT04623866

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-08-30

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.

Conditions

Henoch Schönlein Purpura Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Huaiqihuang Group

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

Group Type: ACTIVE_COMPARATOR

Huaiqinhuang

Intervention Type: 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.

Valsartan group

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Group Type: ACTIVE_COMPARATOR

valsartan

Intervention Type: DRUG

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Interventions

Huaiqinhuang

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.

Intervention Type: DRUG

valsartan

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Intervention Type: DRUG

Other Intervention Names

Huaiqihuang granules; Valsartan capsule

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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);

3. Age: 6-14 years old;

4. Normal renal function: eGFR≥90ml/min/1.73m2;

5. 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.

Exclusion Criteria

1. Abnormal ophthalmic examination (fundus, visual field, photosensitivity);

2. Combined with gross hematuria;

3. Serious diseases of the heart, liver and other important organs, as well as diseases of the blood and endocrine system;

4. Patients who are known to be allergic to any component of Locust and wolfberry yellow or ACEI/ARB;

5. Patients who have participated in other clinical trials within three months before enrollment;

6. 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mao Jianhua

The Children's Hospital of Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mao Jianhua

Role: STUDY_CHAIR

Children's Hospital, Zhejiang University School of Medicine

Locations

The Children Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Mao Jianhua

Role: CONTACT

Phone: 13516819071

Email: maojh88@zju.edu.cn

Other Identifiers

CXPJJH12000003-202017

Identifier Type: -

Identifier Source: org_study_id