A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection(a Chinese Medicine Injection)Used in Hospitals in China

NCT ID: NCT03461692

Last Updated: 2018-03-12

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

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Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-10

Study Completion Date

2018-12-31

Brief Summary

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This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018.

The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description

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In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.

Conditions

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Upper Respiratory Tract Infection Acute Tracheobronchitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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patients under 14 years of age using Reduning injeciton

To assess in patients using Reduning injection's clinical features and drug adverse reaction during patients' hospital stay. The registry procedure will only for patients under 14 years of age using Reduning injection,observed from February 2018 to December 2018.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients aged 14 and below using Reduning injection from February 2018 to December 2018.

Exclusion Criteria

None
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Qilu Children's Hospital of Shandong University

OTHER

Sponsor Role collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Central Contacts

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Yanming Xie, BA

Role: CONTACT

86-13911112416

Lianxin Wang, doctor

Role: CONTACT

86-13521781839

Other Identifiers

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RDN2018

Identifier Type: -

Identifier Source: org_study_id

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