A Registry Study on Reduning（a Chinese Medicine Injection... | NCT01824719

Studies
A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China

NCT01824719

Sponsor

China Academy of Chinese Medical Sciences

Status

Unknown status

Last Update Posted

Apr 5, 2013Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Upper Respiratory Tract Infection;
Acute Tracheobronchitis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Mar 30, 2013

First Submission Date that Met QC Criteria

Apr 2, 2013

First Posted Date

Apr 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2013

Last Update Posted Date

Apr 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanming Xie, Director, China Academy of Chinese Medical SciencesPrincipal Investigator

Lead Sponsor

China Academy of Chinese Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

Eligibility criteria Patients who will use Reduning injection in selected hospitals.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allergic group		All patients who used Reduning Injection have anaphylaxis.
Control group		All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction		to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients using Reduning injection from January to March 2013

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

An anticipated sample size was caculated in this study, about 3000 Patients using Reduning injection from January to March 2013 in hospitals.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xie Y Ming	China Academy of Chinese Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Basic Research in Clinical Medicine	Recruiting	Beijing	Beijing Municipality	100700	China

Type	Date	Date Unknown
Release	Jul 29, 2016
Reset	Sep 16, 2016

Submission Tracking

Estimated Results First Submitted Date

Jul 29, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 29, 2016			Sep 16, 2016

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D001991	Bronchitis

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D001982	Bronchial Diseases
D008173	Lung Diseases, Obstructive

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Browse Branches

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