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| Name | Class |
|---|---|
| Shanxi Zhendong pharmaceutical Co. LTD. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Kuh-seng Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection | 2 years |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who use Compound Kushen Injection in the monitoring hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Zhong Wang, M.D. | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Director |
| Zhan-Yu Pan, Ph.D. | Tianjin medical university cancer institute & hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HanDan Central Hospital | Handan | Hebei | 056001 | China | ||
| Handan First Hospital |
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Serum will be retained from the patients who have the anaphylaxis after given the Compound Kuh-seng Injection and the other 4 matched patients who do not has the anaphylaxis.
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| The incidence of new ADRs to Compound Kuh-seng Injection |
| 2 years |
| The incidence of new SARs to Compound Kuh-seng Injection | 2 years |
| Handan |
| Hebei |
| 056002 |
| China |
| Bai Qiu'en International Peace Hospital | Shijiazhuang | Hebei | 050082 | China |
| Henan University Huaihe Hospital | Kaifeng | Henan | 475001 | China |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | 471000 | China |
| Luoyang Central Hospital Affiliated to Zhengzhou University | Luoyang | Henan | 471009 | China |
| Xinxiang Central Hospital | Xinxiang | Henan | 453000 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453199 | China |
| Xinyang Central Hospital | Xinyang | Henan | 464000 | China |
| People's Hospital of Zhengzhou | Zhengzhou | Henan | 450003 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| The First Hospital of Henan College of Traditional Chinese Medicine | Zhengzhou | Henan | 451199 | China |
| Shandong Provincial Western Hospital | Jinan | Shandong | 250022 | China |
| Qingdao Center Hospital | Qingdao | Shandong | 266031 | China |
| Tai'an Central Hospital | Tai’an | Shandong | 271000 | China |
| The 88th Hospital of People's Liberation Army | Tai’an | Shandong | 271002 | China |
| People's Hospital of Xintai City | Tai’an | Shandong | 271200 | China |
| Weifang No.2 People's Hospital | Weifang | Shandong | 261041 | China |
| Weihai Municipal Hospital | Weihai | Shandong | 264299 | China |
| Central Hospital of Zibo | Zibo | Shandong | 255020 | China |
| Jincheng General Hospital | Jincheng | Shanxi | 048006 | China |
| The Fourth People's Hospital of Linfen | Linfen | Shanxi | 041099 | China |
| Traditional Chinese Hospital of Shanxi | Taiyuan | Shanxi | 030012 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044099 | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | 610017 | China |
| AVIC 363 Hospital | Chengdu | Sichuan | 610041 | China |
| Teaching Hospital of Chengdu University of T.C.M. | Chengdu | Sichuan | 610072 | China |
| The Second People's Hospital of Yibin | Yibin | Sichuan | 644000 | China |
| Tianjin medical university cancer institute & hosptial | Tianjin | Tianjin Municipality | 300060 | China |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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