Status:
COMPLETED
The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
Lead Sponsor:
Qidong Gaitianli Medicines Co., Ltd
Collaborating Sponsors:
Capital Institute of Pediatrics, China
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
1-18 years
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
- Age from 1 to18;
- ALT and AST levels do not exceed twice the upper limit of the normal range;;
- Provision of written informed consent by legal guardians.
Exclusion
- a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
- History of diabetes or examinations showed elevated blood glucose levels;
- Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
- Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
- Patients who are unlikely to adhere to the protocol.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
1507 Patients enrolled
Trial Details
Trial ID
NCT03332420
Start Date
November 16 2017
End Date
August 31 2021
Last Update
December 22 2022
Active Locations (17)
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1
Children's Hospital Capital Institute Of Pediatrics
Beijing, Beijing Municipality, China, 100020
2
Harbin Children's Hospital
Harbin, Heilongjiang, China
3
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
4
Henan Children's Hospital
Zhengzhou, Henan, China