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

NCT03461692 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100000

Last updated 2018-03-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Children's Hospital of Nanjing Medical University

    collaborator OTHER

  • Hunan University of Traditional Chinese Medicine

    collaborator OTHER

  • Qilu Children's Hospital of Shandong University

    collaborator OTHER

  • Zhengzhou Children's Hospital, China

    collaborator OTHER

  • China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Yanming Xie, BA · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Eligibility

Min Age
1 Day
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-10
Primary Completion
2018-03-10
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461692 on ClinicalTrials.gov