ITMCTR2100004424招募中1 期
A single center randomized controlled clinical study on the treatment of Children with Purpura nephritis with Huai-Qi-Huang Granules
Children's Hospital, Zhejiang University School of Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 6 至 14（—）
- 性别
- Male
入选标准
- •(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.
排除标准
- •(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.
研究者
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