The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
1 other identifier
observational
1,507
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
November 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedDecember 22, 2022
December 1, 2022
3.7 years
October 15, 2017
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
Recovery of blood albumin levels
48 Weeks after treatment
Recurrence rate of PNS
48 Weeks after treatment
Rates of infectious complications of PNS
48 Weeks after treatment
Study Arms (3)
Observational 1
Huaiqihuang Granule
Observational 2
Standard treatment+Huaiqihuang Granule
Observational 3
Standard treatment
Eligibility Criteria
Children are diagnosed with primary nephrotic syndrome
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Children's Hospital Capital Institute Of Pediatrics
Beijing, Beijing Municipality, 100020, China
Harbin Children's Hospital
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaoying Chen, Professor
Children's Hospital of The Capital Institute of Pediatrics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2017
First Posted
November 6, 2017
Study Start
November 16, 2017
Primary Completion
July 21, 2021
Study Completion
August 31, 2021
Last Updated
December 22, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share