Overview

This trial is active, not recruiting.

Conditions gastric carcinoma, carcinoma of the lungs
Sponsor China Academy of Chinese Medical Sciences
Start date December 2012
End date December 2014
Trial size 30000 participants
Trial identifier NCT01812876, 2009ZX09502-030-01

Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.

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

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction
time frame: to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients using Shenqifuzheng injection from 2013 to 2014 Exclusion Criteria: - none

Additional Information

Official title A Registry Study on Shenqifuzheng(a Chinese Medicine Injection)Used in Hospitals in China
Principal investigator Xie M Yan
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. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study. A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014. Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.