Safety Study of Shenfu (a Chinese Medicine Injection) Use... | NCT01612533

Studies
Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China

NCT01612533

Sponsor

China Academy of Chinese Medical Sciences

Status

Unknown status

Last Update Posted

Jun 6, 2012Estimated

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Shock
Coronary Heart Disease

Interventions

Not provided

Countries

Not provided

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 3, 2012

First Submission Date that Met QC Criteria

Jun 5, 2012

First Posted Date

Jun 6, 2012Estimated

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

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanming Xie, Deputy 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 October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed Description

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Shenfu 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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.		The registry procedure will last 3 years only for patients using Shenfu.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients using Shenfu injection from 2012 to 2014

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

An anticipated sample size was caculated in this study, about 20000. Patients using Shenmai injection from 2012 to 2014 in 15 hospitals.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yan M Xie, BA	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Jul 26, 2016
Unrelease		Yes
Release	Jul 29, 2016
Reset	Sep 16, 2016

Submission Tracking

Estimated Results First Submitted Date

Jul 26, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 26, 2016		Yes
Jul 29, 2016

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock
D003327	Coronary Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided