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

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: Completed
• Conditions: Adverse Drug Events; Adverse Drug Reactions; Severe Adverse Events; Safety Surveillance; Severe Adverse Reactions
• Intervention / Treatment: Drug: Compound Kuh-seng Injection

• Study Type: Observational
• Enrollment (Actual): 30283

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection	2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection	2 years
The incidence of new ADRs to Compound Kuh-seng Injection	2 years
The incidence of new SARs to Compound Kuh-seng Injection	2 years

Collaborators and Investigators

• Sponsor: Zhong Wang
• Collaborators: Shanxi Zhendong pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Zhan-Yu Pan, Ph.D., Tianjin medical university cancer institute & hosptial

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (ESTIMATE): September 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: Kuh-seng1.0