- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01812876
A Registry Study on Shenqifuzheng(a Chinese Medicine Injection)Used in Hospitals in China
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.
Study Overview
Status
Conditions
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.
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
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients using Shenqifuzheng injection from 2013 to 2014
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xie M Yan, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Stomach Neoplasms
- Lung Neoplasms
- Carcinoma
Other Study ID Numbers
- 2009ZX09502-030-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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