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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.
Ginkgolides Meglumine Injection was jointly developed by China Pharmaceutical University and Jiangsu Kanion Pharmaceutical Co., Ltd. Its pharmacal ingredients are ginkgo lactones , ginkgo lactone B, ginkgo lactone K, etc; Excipients for meglumine, citric acid, sodium chloride. It is used to treat stroke (mild-to-moderate cerebral infarction) in recovery phlegm and Syndrome of Intermingled Phlegm and Blood Stasis.
The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgolides Meglumine Injection | Experimental | Intravenous drip slowly. A 1 (25 mg), will be taken slowly into the 0.9% sodium chloride injection diluted in 250 ml before use, then slow intravenous drip, once a day. The dripping speed must be strictly controlled. For the first time when using, dripping speed should be controlled for 10 ~ 15 drops per minute. After 30 minutes treatment without discomfort, dripping speed can be appropriately increased, but no more than 30 drops per minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgolides Meglumine Injection | Drug | 25mg, intravenous drip, once a day. Number of Cycles: 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| vital signs after 10 minutes of stasis. | 0,14 days | |
| Blood routine tests | 0, 14 days | |
| ECG |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Stroke Scale,NIHSS | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao Ying, Doctor | Dongzhimen Hospital, Beijing | Principal Investigator |
| Zhou Li | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CN051 | Anyang | 455000 | China | |||
| CN071 |
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| 0, 14 days |
| Patient- reported outcomes,PRO | 0, 14 days |
| liver function tests | 0, 14 days |
| kidney function tests | 0, 14 days |
| urine routine tests | 0, 14 days |
| stool routine +occult blood tests | 0, 14 days |
| Coagulation function tests | 0, 14 days |
| Baoding |
| 071000 |
| China |
| CN072 | Baoding | 071000 | China |
| CN073 | Baoding | 071000 | China |
| CN027 | Baotou | 014016 | China |
| CN054 | Baotou | 150200 | China |
| CN001 | Beijing | 100007 | China |
| CN083 | Beijing | 100029 | China |
| CN050 | Binzhou | 256603 | China |
| CN080 | Cangzhou | 06100 | China |
| CN041 | Changchun | 130000 | China |
| CN043 | Changchun | 130022 | China |
| CN029 | Changzhi | 046011 | China |
| CN079 | Chenzhou | 423000 | China |
| CN007 | Dalian | 116021 | China |
| CN044 | Daqing | 163000 | China |
| CN018 | Daqing | 163001 | China |
| CN078 | Handan | 056001 | China |
| CN063 | Ha’erbin | 150001 | China |
| CN045 | Ha’erbin | 150040 | China |
| CN059 | Ha’erbin | 150056 | China |
| CN046 | Ha’erbin | 150076 | China |
| CN076 | Ha’erbin | 150080 | China |
| CN035 | Hefei | 230022 | China |
| CN036 | Hefei | 230061 | China |
| CN024 | Hegang | 154100 | China |
| CN025 | Hegang | 154100 | China |
| CN042 | Hegang | 154211 | China |
| CN052 | Hengshui | 053000 | China |
| CN002 | Hengyang | 421001 | China |
| CN026 | Hohhot | 010010 | China |
| CN070 | Huaihua | 418000 | China |
| CN084 | Huaihua | 418000 | China |
| CN077 | Huanggang | 438000 | China |
| CN040 | Jiamusi | China |
| CN062 | Jilin City | 132000 | China |
| CN022 | Jilin City | 132011 | China |
| CN058 | Jilin City | 132011 | China |
| CN030 | Jinan | 250012 | China |
| CN021 | Jingdezhen | 333003 | China |
| CN057 | Jinzhou | 121000 | China |
| CN075 | Jiujiang | 332000 | China |
| CN088 | Jiujiang | 332000 | China |
| CN069 | Ji’an | 343000 | China |
| CN085 | Ji’an | 343000 | China |
| CN014 | Kaifeng | 475099 | China |
| CN055 | Lianyungang | 222002 | China |
| CN013 | Luohe | 462099 | China |
| CN087 | Luoyang | 471000 | China |
| CN074 | Luoyang | 471003 | China |
| CN056 | Mudanjiang | 157000 | China |
| CN060 | Mudanjiang | 157000 | China |
| CN061 | Mudanjiang | 157000 | China |
| CN068 | Nanchang | 330200 | China |
| CN003 | Nanjing | 210005 | China |
| CN049 | Sanming | 365000 | China |
| CN048 | Shenyang | 110000 | China |
| CN008 | Shenyang | 110032 | China |
| CN006 | Shenyang | 110034 | China |
| CN017 | Shenyang | 110091 | China |
| CN005 | Shenzhen | 518034 | China |
| CN023 | Siping | 136099 | China |
| CN016 | Suihua | 151100 | China |
| CN028 | Taiyuan | 030001 | China |
| CN020 | Tangshan | 063001 | China |
| CN019 | Tangshan | 063003 | China |
| CN034 | Tianjin | 300100 | China |
| CN033 | Tianjin | 300192 | China |
| CN082 | Wuhan | 430060 | China |
| CN032 | Wuhan | 430080 | China |
| CN012 | Xi'an | 710001 | China |
| CN010 | Xi'an | 710054 | China |
| CN031 | Xianning | 437099 | China |
| CN011 | Xianyang | 712021 | China |
| CN009 | Xianyang | 712099 | China |
| CN064 | Xinyu | 338000 | China |
| CN065 | Xinyu | 338025 | China |
| CN004 | Yancheng | 224001 | China |
| CN066 | Yichun | 336000 | China |
| CN067 | Yichun | 336000 | China |
| CN047 | Yiyang | 413000 | China |
| CN038 | Yuncheng | 044000 | China |
| CN039 | Zhenjiang | 212001 | China |
| CN015 | Zhumadian | 463000 | China |
| CN081 | Zhuozhou | 072750 | China |
| CN053 | Zibo | 255000 | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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