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

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Upper Respiratory Tract Infection;; Acute Tracheobronchitis

Study type: Observational

Funder types: Other

Identifiers

NCT01824719

200907001-5-6-1

Details and patient eligibility

About

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Full 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.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

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

Enrollment: 3,000 estimated patients

Sex: All

Ages: 1 month to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients using Reduning injection from January to March 2013

Exclusion criteria

Trial design

3,000 participants in 2 patient groups

Allergic group

Description:

All patients who used Reduning Injection have anaphylaxis.

Control group

Description:

All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.