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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by China Academy of Chinese Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01824719
First received: March 30, 2013
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition
Upper Respiratory Tract Infection;
Acute Tracheobronchitis

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China

Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: January 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Allergic group
All patients who used Reduning Injection have anaphylaxis.
Control group
All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

An anticipated sample size was caculated in this study, about 3000 Patients using Reduning injection from January to March 2013 in hospitals.

Criteria

Inclusion Criteria:

  • Patients using Reduning injection from January to March 2013

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824719

Locations
China, Beijing
Institute of Basic Research in Clinical Medicine Recruiting
Beijing, Beijing, China, 100700
Contact: Jiang J Jie    010-64014411 ext 2802    studentjiangjunjie@tom.com   
Principal Investigator: Xie M Yan, BA         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Xie Y Ming China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Yanming Xie, Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01824719     History of Changes
Other Study ID Numbers: 200907001-5-6-1
Study First Received: March 30, 2013
Last Updated: April 2, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Anaphylaxis
Respiratory Tract Infections
Bronchitis
Acute Disease
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Infection
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014