The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Qidong Gaitianli Medicines Co., Ltd1,507 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,507

Conditions

Nephrotic Syndrome

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Children's Hospital Capital Institute Of Pediatrics

Beijing, Beijing Municipality, China

Harbin Children's Hospital

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

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.

Time frame: 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.