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

Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01812876
• Other study ID #: 2009ZX09502-030-01
• Status: Unknown status
• Phase: N/A
• First received: March 14, 2013
• Last updated: April 15, 2013
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients using Shenqifuzheng injection from 2013 to 2014

Exclusion Criteria:

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of the Lungs
• Gastric Carcinoma
• Lung Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction	All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge. Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shenqifuzheng	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