Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01824719
Enrollment
3000
Registered
2013-04-05
Start date
2013-01-31
Completion date
2013-04-30
Last updated
2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Tracheobronchitis, Upper Respiratory Tract Infection;

Brief 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.

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. 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.

Interventions

None listed

Sponsors

China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients using Reduning injection from January to March 2013

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reactionto 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026