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

Acute Tracheobronchitis Clinical Trial

Official title:

a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01824719
• Other study ID #: 200907001-5-6-1
• Status: Unknown status
• Phase: N/A
• First received: March 30, 2013
• Last updated: April 2, 2013
• Start date: January 2013
• Est. completion date: April 2013

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 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 3000
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 80 Years

Eligibility

Inclusion Criteria:

• Patients using Reduning injection from January to March 2013

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Tracheobronchitis
• Bronchitis
• Respiratory Tract Infections
• Upper Respiratory Tract Infection;

Locations

Country	Name	City	State
China	Institute of Basic Research in Clinical Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction		to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning