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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
incidence of severe adverse drug reactions
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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