CClinicalTrials.gg
Status unknownNCT01612611Updated Jun 6, 2012

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

An observational study in Shock and Coronary Heart Disease, sponsored by China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by China Academy of Chinese Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30,000
Sex
All
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Study summary

The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

Read the 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 shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

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

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all inpatients used Shenmai injection in 30 selected hospitals in mainland China

Inclusion criteria

  • all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30,000 participants (estimated)

Groups and cohorts

  • a cohort using Shenmai injection
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Study locations

1 site
  • Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
    Beijing, Beijing 100700, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01612611
Lead sponsor
China Academy of Chinese Medical Sciences
Collaborators
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Responsible party
Yanming Xie (Deputy Director, China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Jun 6, 2012
Start date
Jan 2012
Completion
Dec 2015 (estimated)
Last update
Jun 6, 2012

Study contacts

Yan M Xie
principal investigator · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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