The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Qidong Gaitianli Medicines

Status: Completed

Conditions: Nephrotic Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03332420

HQH-201705

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 1,507 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Age from 1 to18;
3. ALT and AST levels do not exceed twice the upper limit of the normal range;;
4. Provision of written informed consent by legal guardians.

Exclusion criteria

1. 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;
2. with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
3. History of diabetes or examinations showed elevated blood glucose levels;
4. Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
5. Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
6. Patients who are unlikely to adhere to the protocol.

Trial design

1,507 participants in 3 patient groups

Observational 1

Description:

Huaiqihuang Granule

Observational 2

Description:

Standard treatment+Huaiqihuang Granule

Observational 3

Description:

Standard treatment