MedDataX Logo

The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

NCT ID: NCT03332420

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-16

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrotic Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Huaiqihuang granule primary nephrotic syndrome multisite prospective open-label

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational 1

Huaiqihuang Granule

No interventions assigned to this group

Observational 2

Standard treatment+Huaiqihuang Granule

No interventions assigned to this group

Observational 3

Standard treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

Qidong Gaitianli Medicines Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chaoying Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of The Capital Institute of Pediatrics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital Capital Institute Of Pediatrics

Beijing, Beijing Municipality, China

Site Status

Harbin Children's Hospital

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Xinxiang Medical University

Weihui, Henan, China

Site Status

Henan Children's Hospital

Zhengzhou, Henan, China

Site Status

Benq Medical Center

Nanjing, Jiangsu, China

Site Status

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Wuxi Children's Hospital

Wuxi, Jiangsu, China

Site Status

Xuzhou Children's Hospital

Xuzhou, Jiangsu, China

Site Status

Jiangxi Provincal Children's Hospital

Nanchang, Jiangxi, China

Site Status

The first Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Children's Hospital of Shanxi

Taiyuan, Shanxi, China

Site Status

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Site Status

Urumqi first people's Hospital

Ürümqi, Xinjiang, China

Site Status

Children's Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Tianjin Children's Hospital

Tianjin, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HQH-201705

Identifier Type: -

Identifier Source: org_study_id