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

18 Years
Open (Enrolling)
Gastric Carcinoma, Carcinoma of the Lungs

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Trial Information

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

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

Inclusion Criteria:

- Patients using Shenqifuzheng injection from 2013 to 2014

Exclusion Criteria:

- none

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction

Outcome Description:

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

Outcome 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

Safety Issue:


Principal Investigator

Xie M Yan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences


China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Study ID:




Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

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