A single center randomized controlled clinical study on the treatment of Children with Purpura nephritis with Huai-Qi-Huang Granules

Phase 1

Recruiting

• Conditions: Children with purpura nephritis

• Registration Number: ITMCTR2100004424
• Lead Sponsor: Children's Hospital, Zhejiang University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood biochemistry;lymphocyte subsets (including Th1 cells, Th2 cells, Th17 cells);immunoglobulin + complement;protenuria;cytokines (IL-16, IL-10, IL-17, etc.);