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| Name | Class |
|---|---|
| Shanxi Zhendong Pharmacy Co., Ltd | INDUSTRY |
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This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qizhi Tongluo Capsules | Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qizhi Tongluo Capsules | Drug | Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules | 3 years | |
| The incidence of new ADRs to the Qizhi Tongluo Capsules | 3 years | |
| The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Wang | Contact | 86-10-64093207 | zhonw@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningming County Hospital of Chinese Medicine | Recruiting | Changzuo | Guangxi | 532500 | China |
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| 3 years |
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL) | 3 years |
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA) | 3 years |
| Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement). | 3 years |
| Fangchenggang City Hospital of Chinese Medicine | Not yet recruiting | Fangchenggang | Guangxi | 538021 | China |
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| The First Affiliated Hospital of Guangxi University of Chinese Medicine | Recruiting | Nanning | Guangxi | 530023 | China |
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| Shanglin County Hospital of Chinese Medicine | Recruiting | Nanning | Guangxi | 530500 | China |
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| Long'an County Hospital of Chinese Medicine | Recruiting | Nanning | Guangxi | 532799 | China |
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| Luohe Hospital of traditional Chinese Medicine | Recruiting | Luohe | Henan | 462000 | China |
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| The First Affiliated Hospital of Nanyang Medical College | Withdrawn | Nanyang | Henan | 473000 | China |
| The Second Affiliated Hospital of Nanyang Medical College | Recruiting | Nanyang | Henan | 473000 | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Not yet recruiting | Xinxiang | Henan | 453199 | China |
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| The First Affiliated Hospital of Henan University of traditional Chinese Medicine | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The Third Affiliated Hospital of Henan University of traditional Chinese Medicine | Withdrawn | Zhengzhou | Henan | 450003 | China |
| Affiliated Hospital of Yanbian University | Withdrawn | Yanbian | Jilin | 133000 | China |
| The Second Affiliated Hospital of Shandong University of Chinese Medicine | Recruiting | Jinan | Shandong | 250001 | China |
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| Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine | Recruiting | Changzhi | Shanxi | 046000 | China |
|
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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