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

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ClinicalTrials.gov Identifier: NCT01764204
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

Brief Summary:
To highlight the incidence of adverse reactions of Qingkailing Injection.

Condition or disease Intervention/treatment
Adverse Drug Events Adverse Drug Reactions Drug: Qingkailing Injection

Study Type : Observational
Actual Enrollment : 30840 participants
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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 Name: Shineway Qingkailing Injection




Primary Outcome Measures :
  1. incidence of severe adverse drug reactions [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. incidence of adverse drug reactions [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
whole blood of the patient with severe adverse drug reactions


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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764204


  Show 48 Study Locations
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

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
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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