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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

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ClinicalTrials.gov Identifier: NCT03461692
Recruitment Status : Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Children’s Hospital of Nanjing Medical University
The First Hospital of Hunan University of Chinese Medicine
Qilu Children's Hospital of Shandong University
Zhengzhou Children's Hospital, China
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

Brief 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.


Condition or disease Intervention/treatment
Upper Respiratory Tract Infection Acute Tracheobronchitis Drug: patients under 14 years of age using Reduning injeciton

Detailed Description:
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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China
Estimated Study Start Date : March 10, 2018
Estimated Primary Completion Date : March 10, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Incidence of Adverse Drug Reaction [ Time Frame: 3 days ]
    Incidence of Reduning Injection'Adverse Drug Reaction(ADRs)and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction


Secondary Outcome Measures :
  1. The Ratio of Body Temperature to Normal [ Time Frame: 3 days ]
    The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)

  2. The Ratio of WBC to Normal [ Time Frame: 3 days ]
    The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L)

  3. The Ratio of The Antibiotic Used [ Time Frame: 3 days ]
    Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.


Biospecimen Retention:   Samples Without DNA
Under the patients'premise of consent and the signature of the informed consent, drawing the blood samples 5ml from the patients with allergic reactions and the patients without adverse reactions.The patients who responded to the 1:4 ratio matched the patients who had no adverse reactions (with the same sex, age difference within 5 years as the matching conditions)are intended for inflammatory factors to explore the mechanism of anaphylaxis.


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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461692


Contacts
Contact: Yanming Xie, BA 86-13911112416 datamining5288@163.com
Contact: Lianxin Wang, doctor 86-13521781839 wanglianxin_tcm@126.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Children’s Hospital of Nanjing Medical University
The First Hospital of Hunan University of Chinese Medicine
Qilu Children's Hospital of Shandong University
Zhengzhou Children's Hospital, China
Investigators
Principal Investigator: Yanming Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03461692     History of Changes
Other Study ID Numbers: RDN2018
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Tract Infections
Bronchitis
Infection
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases