CompletedNot Applicable

The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

China1,507 participantsStarted 2017-11-16

Plain-language 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.

Who can participate

Age range1 Year – 18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Duration of positive urine protein test changing to the negative result

Timeframe: 48 weeks after treatment

The ratio of positive to negative urine protein

Timeframe: 48 Weeks after treatment

The decrease of 24-hour urine protein level

Timeframe: 48 Weeks after treatment

Trial details

NCT IDNCT03332420

SponsorQidong Gaitianli Medicines Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-07-21

View on ClinicalTrials.gov More Nephrotic Syndrome trials