Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239237
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Shanxi Zhendong pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.

Condition or disease Intervention/treatment
Safety Surveillance Adverse Drug Events Adverse Drug Reactions Severe Adverse Events Severe Adverse Reactions Drug: Compound Kuh-seng Injection

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 30283 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : October 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Compound Kuh-seng Injection
Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.
 Drug: Compound Kuh-seng Injection
Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.
Other Names:
  • Compound Kushen Injection
  • Fufang Kushen Zhusheye


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection [ Time Frame: 2 years ]
  2. The incidence of anaphylactic reaction to Compound Kuh-seng Injection [ Time Frame: 2 years ]
  3. The incidence of new ADRs to Compound Kuh-seng Injection [ Time Frame: 2 years ]
  4. The incidence of new SARs to Compound Kuh-seng Injection [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Serum will be retained from the patients who have the anaphylaxis after given the Compound Kuh-seng Injection and the other 4 matched patients who do not has the anaphylaxis.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who use Compound Kushen Injection in the monitoring hospitals
Criteria

Inclusion Criteria:

  • Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria:

  • None
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02239237


Locations
Show Show 29 study locations
Sponsors and Collaborators
Zhong Wang
Shanxi Zhendong pharmaceutical Co. LTD.
Investigators
Layout table for investigator information
Study Director: Zhong Wang, M.D. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Principal Investigator: Zhan-Yu Pan, Ph.D. Tianjin medical university cancer institute & hosptial
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zhong Wang, Dr, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02239237    
Other Study ID Numbers: Kuh-seng1.0
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders