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

October 9, 2018 updated by: Zhong Wang
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.

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.
30283

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
    • Hebei
      • HanDan, Hebei, China, 056001
        • Handan Central Hospital
      • Handan, Hebei, China, 056002
        • Handan First Hospital
      • Shijiazhuang, Hebei, China, 050082
        • Bai Qiu'en International Peace Hospital
    • Henan
      • Kaifeng, Henan, China, 475001
        • Henan University Huaihe Hospital
      • Luoyang, Henan, China, 471000
        • The First Affiliated Hospital of Henan University of Science & Technology
      • Luoyang, Henan, China, 471009
        • Luoyang Central Hospital Affiliated to Zhengzhou University
      • Xinxiang, Henan, China, 453000
        • Xinxiang Central Hospital
      • Xinxiang, Henan, China, 453199
        • The First Affiliated Hospital of Xinxiang Medical University
      • Xinyang, Henan, China, 464000
        • Xinyang Central Hospital
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450003
        • People's Hospital of Zhengzhou
      • Zhengzhou, Henan, China, 451199
        • The First Hospital of Henan College of Traditional Chinese Medicine
    • Shandong
      • Jinan, Shandong, China, 250022
        • Shandong Provincial Western Hospital
      • Qingdao, Shandong, China, 266031
        • Qingdao Center Hospital
      • Tai'an, Shandong, China, 271000
        • Tai'an Central Hospital
      • Tai'an, Shandong, China, 271002
        • The 88th Hospital of People's Liberation Army
      • Tai'an, Shandong, China, 271200
        • People's Hospital of Xintai City
      • Weifang, Shandong, China, 261041
        • Weifang NO.2 People's Hospital
      • Weihai, Shandong, China, 264299
        • Weihai Municipal Hospital
      • Zibo, Shandong, China, 255020
        • Central Hospital of Zibo
    • Shanxi
      • Jincheng, Shanxi, China, 048006
        • Jincheng General Hospital
      • Linfen, Shanxi, China, 041099
        • The Fourth People's Hospital of Linfen
      • Taiyuan, Shanxi, China, 030012
        • Traditional Chinese Hospital of Shanxi
      • Yuncheng, Shanxi, China, 044099
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Chengdu Second People's Hospital
      • Chengdu, Sichuan, China, 610041
        • Avic 363 Hospital
      • Chengdu, Sichuan, China, 610072
        • Teaching Hospital of Chengdu University of T.C.M.
      • Yibin, Sichuan, China, 644000
        • The Second People's Hospital of Yibin
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin medical university cancer institute & hosptial

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who use Compound Kushen Injection in the monitoring hospitals

Description

Inclusion Criteria:

  • Patients who use Compound Kushen Injection in the monitoring hospitals

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

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.
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

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
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
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
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
Time Frame: 2 years
2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection
Time Frame: 2 years
2 years
The incidence of new ADRs to Compound Kuh-seng Injection
Time Frame: 2 years
2 years
The incidence of new SARs to Compound Kuh-seng Injection
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.
Zhong Wang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanxi Zhendong pharmaceutical Co. LTD.

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: Zhan-Yu Pan, Ph.D., Tianjin medical university cancer institute & hosptial

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.
September 1, 2014

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.
June 1, 2018

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.
October 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).
September 10, 2014

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.
September 10, 2014

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.
September 12, 2014

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.
October 10, 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.
October 9, 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.
October 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.
  • Kuh-seng1.0

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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