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| Name | Class |
|---|---|
| Capital Institute of Pediatrics, China | OTHER |
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This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational 1 | Huaiqihuang Granule | ||
| Observational 2 | Standard treatment+Huaiqihuang Granule | ||
| Observational 3 | Standard treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of positive urine protein test changing to the negative result | Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks. | 48 weeks after treatment |
| The ratio of positive to negative urine protein | The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks. | 48 Weeks after treatment |
| The decrease of 24-hour urine protein level | Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks. | 48 Weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of blood albumin levels | Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks. | 48 Weeks after treatment |
| Recurrence rate of PNS | The proportion of recurrent subjects to the total number of subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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Children are diagnosed with primary nephrotic syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Chaoying Chen, Professor | Children's Hospital of The Capital Institute of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Capital Institute Of Pediatrics | Beijing | Beijing Municipality | 100020 | China | ||
| Harbin Children's Hospital |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 48 Weeks after treatment |
| Rates of infectious complications of PNS | The proportion of complicated infectious subjects to the total number of subjects. | 48 Weeks after treatment |
| Harbin |
| Heilongjiang |
| China |
| The First Affiliated Hospital of Xinxiang Medical University | Weihui | Henan | China |
| Henan Children's Hospital | Zhengzhou | Henan | China |
| Benq Medical Center | Nanjing | Jiangsu | China |
| Children's Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| Children's Hospital of Soochow University | Suzhou | Jiangsu | China |
| Wuxi Children's Hospital | Wuxi | Jiangsu | China |
| Xuzhou Children's Hospital | Xuzhou | Jiangsu | China |
| Jiangxi Provincal Children's Hospital | Nanchang | Jiangxi | China |
| The first Bethune Hospital of Jilin University | Changchun | Jilin | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Children's Hospital of Shanxi | Taiyuan | Shanxi | China |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | China |
| Urumqi first people's Hospital | Ürümqi | Xinjiang | China |
| Children's Hospital of Chongqing Medical University | Chongqing | China |
| Tianjin Children's Hospital | Tianjin | China |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |