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

February 15, 2018 updated by: Zhong Wang, China Academy of Chinese Medical Sciences

Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years

To highlight the incidence of adverse reactions of Qingkailing Injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100094
        • National Defense University Hospital of People's Liberation Army
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Ren'ai Hospital
      • Zhaoqing, Guangdong, China, 526600
        • Chinese Medicine Hospital of Deqing County
    • Hebei
      • Baoding, Hebei, China, 071599
        • Chinese Medicine Hospital of Gaoyang County
      • Baoding, Hebei, China, 071599
        • Gaoyang County Hospital
      • Baoding, Hebei, China, 071802
        • The Third People's Hospital of Xiong County
      • Baoding, Hebei, China, 071899
        • Chinese Medicine Hospital of Xiong County
      • Baoding, Hebei, China, 072350
        • Chinese Medicine Hospital of Tang County
      • Baoding, Hebei, China, 072350
        • People's Hospital of Tang County
      • Handan, Hebei, China, 056001
        • Chinese Medicine Hospital of Handan City
      • Handan, Hebei, China, 057150
        • The First Hospital of Yongnian District
      • Handan, Hebei, China, 057150
        • The Second Hospital of Yongnian District
      • Shijiazhuang, Hebei, China, 050011
        • Central Hospital of Shijiazhuang City
      • Shijiazhuang, Hebei, China, 050041
        • Hebei Chest Hospital
      • Shijiazhuang, Hebei, China, 050061
        • Chinese Medicine Hospital of Shijiazhuang City
      • Xingtai, Hebei, China, 054000
        • Central Hospital of Qinghe County
      • Xingtai, Hebei, China, 054001
        • Chinese Medicine Hospital of Xingtai City
      • Xingtai, Hebei, China, 054001
        • Eye Hospital of Xingtai City
      • Xingtai, Hebei, China, 054099
        • The Second Affiliated Hospital of Xingtai Medical College
      • Xingtai, Hebei, China, 054800
        • Chinese Medicine Hospital of Qinghe County
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 151801
        • The Second Hospital of Bayan County
    • Henan
      • Luohe, Henan, China, 462099
        • Luohe Hospital of Chinese Medicine
      • Sanmenxia, Henan, China, 472100
        • People's Hospital of Shan County
      • Sanmenxia, Henan, China, 472500
        • The First People's Hospital of Lingbao
      • Sanmenxia City, Henan, China, 472000
        • Central Hospital of Sanmenxia City
      • Xinxiang, Henan, China, 453003
        • Chinese Medicine Hospital of Xinxiang City
      • Xinxiang, Henan, China, 453003
        • The Third Affiliated Hospital of Xinxiang Medical University
      • Xinxiang, Henan, China, 453200
        • People's Hospital of Yanjin County
      • Xinxiang, Henan, China, 453300
        • Chinese Medicine Hospital of Fengqiu County
      • Xinxiang, Henan, China, 453399
        • People's Hospital of Fengqiu County
      • Xinxiang, Henan, China, 453500
        • People's Hospital of Yuanyang County
      • Xinzheng, Henan, China, 451100
        • People's Hospital of Xinzheng City
      • Zhengzhou, Henan, China, 450008
        • Third Affiliated Hospital of Henan College of Traditional Chinese Medicine
      • Zhengzhou, Henan, China, 451199
        • Chinese Medicine Hospital of Xinzheng
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Affiliated Zhongshan Hospital of Dalian University
    • Shandong
      • Liaocheng, Shandong, China, 252001
        • Central Hospital of Liaocheng City
      • Liaocheng, Shandong, China, 252003
        • Veterans'Hospital
      • Liaocheng, Shandong, China, 252027
        • Chinese Medicine Hospital of Dongchangfu District
      • Liaocheng, Shandong, China, 252100
        • Chinese Medicine Hospital of Chiping County
      • Liaocheng, Shandong, China, 252300
        • YangGuXian People's Hospital
      • Liaocheng, Shandong, China, 252661
        • Chinese Medicine Hospital of Linqing
      • Liaocheng, Shandong, China, 252800
        • Chinese Medicine Hospital of Gaotang County
    • Shanxi
      • Weinan, Shanxi, China
        • Community Health Center of Duqiao
      • Xianyang, Shanxi, China, 713800
        • Chinese Medicine Hospital of Sanyuan County
    • Yunnan
      • Qujing, Yunnan, China, 655500
        • People's Hospital of Fuyuan County
      • Qujing, Yunnan, China, 655600
        • Chinese Medicine Hospital of Luliang County
      • Qujing, Yunnan, China, 655600
        • People's Hospital of Luliang County
      • Qujing, Yunnan, China, 655700
        • Chinse Medical Hospital of Shizong County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Shineway Qingkailing Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of severe adverse drug reactions
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of adverse drug reactions
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qingkailing-V5.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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