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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04623866
• Date of registration: 25/10/2020
• Prospective Registration: Yes
• Primary sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Public title: Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
• Scientific title: A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
• Date of first enrolment: November 1, 2020
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04623866
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

China

Contacts

• Name: Mao Jianhua

• Name: Mao Jianhua
• Affiliation: Children's Hospital, Zhejiang University School of Medicine

Key inclusion & exclusion 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 ? magnitude or hints chronic purpura
nephritis.



Age minimum: 6 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Henoch Schönlein Purpura Nephritis

Intervention(s)

Drug: valsartan

Drug: Huaiqinhuang

Primary Outcome(s)

change of urinary protein [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

Change in renal function of the patients [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

change of urine red blood cells [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

change of immunoglobulin + complement [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

change of lymphocyte subsets [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

Secondary Outcome(s)

Change of blood pressure [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

change of BMI(Body Mass Index) [Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization]

Secondary ID(s)

CXPJJH12000003-202017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors