Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01764204
First received: January 7, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

To highlight the incidence of adverse reactions of Qingkailing Injection.


Condition Intervention
Adverse Drug Events
Adverse Drug Reactions
Drug: Qingkailing Injection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • incidence of severe adverse drug reactions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of adverse drug reactions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood of the patient with severe adverse drug reactions


Estimated Enrollment: 30000
Study Start Date: January 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Qingkailing Injection Drug: Qingkailing Injection
Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.
Other Name: Shineway Qingkailing Injection

  Eligibility

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

all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.

Criteria

Inclusion Criteria:

  • all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.

    • in accordance with ethics requirements.

Exclusion Criteria:

  • none.
  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: NCT01764204

Contacts
Contact: Zhong Wang, Ph. D. 8610-64014411 ext 3308 zhonw@vip.sina.com
Contact: Jun Liu, Ph. D. 8610-64014411 ext 2805 franlj1104@yahoo.com.cn

Locations
China, Guangdong
Ren'ai Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Jun Sun    86-13725560997      
Principal Investigator: Jun Sun         
Chinese Medicine Hospital of Deqing County Recruiting
Zhaoqing, Guangdong, China, 526600
Contact: Li-huan Liang    0758-7799609      
Principal Investigator: Li-huan Liang         
China, Hebei
Hebei Chest Hospital Recruiting
Shijiazhuang, Hebei, China, 050041
Contact: Yan-hong Shen    0311-86916189      
Principal Investigator: Yan-hong Shen         
Central Hospital of Shijiazhuang City Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Xiao-hua Ren    0311-87280340      
Principal Investigator: Xiao-hua Ren         
Chinese Medicine Hospital of Shijiazhuang City Recruiting
Shijiazhuang, Hebei, China, 050061
Contact: Li-hong Jiao    0311-85511680      
Principal Investigator: Li-hong Jiao         
Central Hospital of Qinghe County Recruiting
Xingtai, Hebei, China, 054000
Contact: Yuan    0319-8181198      
Principal Investigator: Yuan         
Eye Hospital of Xingtai City Recruiting
Xingtai, Hebei, China, 054001
Contact: Zhi-jin Li    0319-7615282      
Principal Investigator: Zhi-jin Li         
Chinese Medicine Hospital of Qinghe County Recruiting
Xingtai, Hebei, China, 054800
Contact: Xiu-ting Yang    13932925116      
Principal Investigator: Xiu-ting Yang         
China, Henan
Central Hospital of Sanmenxia City Recruiting
Sanmenxia City, Henan, China, 472000
Contact: Jian-tang Zhang    15139891688      
Principal Investigator: Jian-tang Zhang         
People's Hospital of Xinzheng City Recruiting
Xinzheng, Henan, China, 451100
Contact: Cheng-di Li    15981990523      
Principal Investigator: Cheng-di Li         
Third Affiliated Hospital of Henan College of Traditional Chinese Medicine Recruiting
Zhengzhou, Henan, China, 450008
Contact: Fang Qin    15937102726      
Principal Investigator: Fang Qin         
Chinese Medicine Hospital of Guancheng Withdrawn
Zhengzhou, Henan, China, 450000
China, Liaoning
Affiliated Zhongshan Hospital of Dalian University Recruiting
Dalian, Liaoning, China, 116001
Contact: Jing He    13654268646      
Principal Investigator: Jing He         
China, Shandong
Rencheng District Chinse Medical Hospital of Jining City Withdrawn
Jining, Shandong, China, 272067
Liaocheng Dongchangfu People's Hospital Withdrawn
Liaocheng, Shandong, China, 252002
The Fourth People's Hospital of Liaocheng City Withdrawn
Liaocheng, Shandong, China, 252000
Chinese Medicine Hospital of Chiping County Recruiting
Liaocheng, Shandong, China, 252100
Contact: Qiu-hong Ma    0635-4272419      
Principal Investigator: Qiu-hong Ma         
People's Hospital of Shenxian County Withdrawn
Liaocheng, Shandong, China, 252400
YangGuXian People's Hospital Recruiting
Liaocheng, Shandong, China, 252300
Contact: Yan Zhang    86-15863593696      
Principal Investigator: Yan Zhang         
Chinese Medicine Hospital of Qufu City Recruiting
Qufu, Shandong, China, 273100
Contact: Zhonghai Li    86-537-4495353      
Principal Investigator: Zhonghai Li         
China, Shanxi
Central Hospital of Chenghekuangwuju Withdrawn
Weinan, Shanxi, China
Community Health Center of Duqiao Recruiting
Weinan, Shanxi, China
Contact: Chun-juan Li    13892345456      
Principal Investigator: Chun-juan Li         
Chinese Medicine Hospital of Sanyuan County Recruiting
Xianyang, Shanxi, China, 713800
Contact: Ya-xing Zou    13572780068      
Principal Investigator: Ya-xing Zou         
Chinese Medicine Hospital of Qian County Recruiting
Xianyang, Shanxi, China
Contact: Yang-lin Zhang    13572765661      
Principal Investigator: Yang-lin Zhang         
China, Yunnan
People's Hospital of Luliang County Recruiting
Qujing, Yunnan, China, 655600
Contact: Feng-qin Qian    86-13988975288      
Principal Investigator: Feng-qin Qian         
Chinse Medical Hospital of Shizong County Recruiting
Qujing, Yunnan, China, 655700
Contact: Ru-xuan Zhou    13577499749      
Principal Investigator: Ru-xuan Zhou         
Chinese Medicine Hospital of Luliang County Recruiting
Qujing, Yunnan, China, 655600
Contact: Jia-hong Yin    86-15924916777      
Principal Investigator: Jia-hong Yin         
People's Hospital of Fuyuan County Recruiting
Qujing, Yunnan, China, 655500
Contact: Yan Yang    13887174688      
Principal Investigator: Yan Yang         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Zhong Wang, Ph.D., M.D. Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01764204     History of Changes
Other Study ID Numbers: Qingkailing-V5.0
Study First Received: January 7, 2013
Last Updated: September 10, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 29, 2014