Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
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ClinicalTrials.gov Identifier: NCT04623866 |
Recruitment Status : Unknown
Verified November 2020 by Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Henoch Schönlein Purpura Nephritis | Drug: Huaiqinhuang Drug: valsartan | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules |
Estimated Study Start Date : | November 1, 2020 |
Estimated Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | August 30, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Huaiqihuang Group
Huaiqihuang granules 60g/1.73m2 bid 24 weeks
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Drug: 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.
Other Name: Huaiqihuang granules |
Active Comparator: Valsartan group
Valsartan granules 80mg/1.73m2 based qd 24 weeks
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Drug: valsartan
Valsartan granules 80mg/1.73m2 based qd 24 weeks
Other Name: Valsartan capsule |
- change of urinary protein [ Time Frame: 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 [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]blood chemistry
- change of lymphocyte subsets [ Time Frame: 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 [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]immunoglobulin + complement
- change of urine red blood cells [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]red blood cells routine urine
- Change of blood pressure [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]blood pressure
- change of BMI(Body Mass Index) [ Time Frame: 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)

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Ages Eligible for Study: | 6 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623866
Contact: Mao Jianhua | 13516819071 | maojh88@zju.edu.cn |
China, Zhejiang | |
The Children Hospital of Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China, 310006 | |
Children's Hospital, Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China |
Study Chair: | Mao Jianhua | Children's Hospital, Zhejiang University School of Medicine |
Responsible Party: | Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine |
ClinicalTrials.gov Identifier: | NCT04623866 |
Other Study ID Numbers: |
CXPJJH12000003-202017 |
First Posted: | November 10, 2020 Key Record Dates |
Last Update Posted: | November 10, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We could not share data without patients' agreement |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nephritis Purpura, Schoenlein-Henoch Purpura Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Kidney Diseases Urologic Diseases Vasculitis Vascular Diseases |
Cardiovascular Diseases Hemostatic Disorders Hemorrhagic Disorders Immune Complex Diseases Hypersensitivity Immune System Diseases Valsartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |