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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004424
Enrollment
Unknown
Registered
2020-11-06
Start date
2020-11-06
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with purpura nephritis

Interventions

Sponsors

Children's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
6 Years to 14 Years

Inclusion 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

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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactMao Jianhua

Children's Hospital, Zhejiang University School of Medicine

maojh88@zju.edu.cn+86 13516819071

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026