Clinical Trials Logo
  1. Home
  2. Adverse Drug Events
  3. NCT02239237
  4. Details
NCT02239237 Clinical Trial

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

Adverse Drug Events Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02239237
Other study ID # Kuh-seng1.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date October 2018

Study information
Verified date October 2018
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30283
Est. completion date October 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China AVIC 363 Hospital Chengdu Sichuan
China Chengdu Second People's Hospital Chengdu Sichuan
China Teaching Hospital of Chengdu University of T.C.M. Chengdu Sichuan
China HanDan Central Hospital HanDan Hebei
China Handan First Hospital Handan Hebei
China Shandong Provincial Western Hospital Jinan Shandong
China Jincheng General Hospital Jincheng Shanxi
China Henan University Huaihe Hospital Kaifeng Henan
China The Fourth People's Hospital of Linfen Linfen Shanxi
China Luoyang Central Hospital Affiliated to Zhengzhou University Luoyang Henan
China The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
China Qingdao Center Hospital Qingdao Shandong
China Bai Qiu'en International Peace Hospital Shijiazhuang Hebei
China People's Hospital of Xintai City Tai'an Shandong
China Tai'an Central Hospital Tai'an Shandong
China The 88th Hospital of People's Liberation Army Tai'an Shandong
China Traditional Chinese Hospital of Shanxi Taiyuan Shanxi
China Tianjin medical university cancer institute & hosptial Tianjin Tianjin
China Weifang No.2 People's Hospital Weifang Shandong
China Weihai Municipal Hospital Weihai Shandong
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China Xinxiang Central Hospital Xinxiang Henan
China Xinyang Central Hospital Xinyang Henan
China The Second People's Hospital of Yibin Yibin Sichuan
China Yuncheng Central Hospital Yuncheng Shanxi
China Henan Cancer Hospital Zhengzhou Henan
China People's Hospital of Zhengzhou Zhengzhou Henan
China The First Hospital of Henan College of Traditional Chinese Medicine Zhengzhou Henan
China Central Hospital of Zibo Zibo Shandong

Sponsors (2)
Lead Sponsor Collaborator
Zhong Wang Shanxi Zhendong pharmaceutical Co. LTD.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection 2 years
Secondary The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection 2 years
Secondary The incidence of anaphylactic reaction to Compound Kuh-seng Injection 2 years
Secondary The incidence of new ADRs to Compound Kuh-seng Injection 2 years
Secondary The incidence of new SARs to Compound Kuh-seng Injection 2 years
See also
  Status Clinical Trial Phase
Completed NCT01179867 - Using Novel Canadian Resources to Improve Medication Reconciliation at Discharge N/A
Completed NCT02191358 - YouScript IMPACT Registry N/A
Completed NCT02059044 - Information Systems-enabled Outreach Program for Adverse Drug Events N/A
Completed NCT01164137 - Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care N/A
Completed NCT02482025 - The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial N/A
Completed NCT04692220 - Drug-Related Problems : Focus on Age and Diabetes
Completed NCT02378220 - Pharmacogenetic Testing Among Home Health Patients N/A
Completed NCT01337063 - Multi-Center Medication Reconciliation Quality Improvement Study N/A
Completed NCT02593916 - Response to Medication Registry
Completed NCT00013143 - Patient Profiling and Provider Feedback to Reduce Adverse Drug Events N/A
Withdrawn NCT00606606 - Reducing Adverse Drug Events in the Nursing Home N/A
Completed NCT02026453 - Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy N/A
Completed NCT02805270 - Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization N/A
Completed NCT01764204 - Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years N/A
Completed NCT01531088 - Enhancing the Detection and Management of Adverse Drug Events in Nursing Homes N/A
Completed NCT02122965 - The Effect of Medication Review in High-risk Emergency Department Patients N/A
Completed NCT00780572 - Implementation of Real-time ADE Surveillance and Decision Support N/A
Completed NCT01091038 - Improving Safety by Basic Computerizing Outpatient Prescribing Phase 2/Phase 3
Recruiting NCT04479553 - Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
Active, not recruiting NCT00740675 - Ambulatory Medication Reconciliation Following Hospital Discharge N/A