Adverse Drug Events Clinical Trial
Official title:
Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
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 |
Verified date | October 2018 |
Source | China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: |
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 |
Lead Sponsor | Collaborator |
---|---|
Zhong Wang | Shanxi Zhendong pharmaceutical Co. LTD. |
China,
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 |
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