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| Name | Class |
|---|---|
| Handan Central Hospital | OTHER |
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This is a randomized, double-blind, placebo-parallel-controlled multiplier designed to observe and evaluate the efficacy and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days and continue follow-up to 90 days after the onset of the disease.
Cerebral infarction (CI), also known as ischemic stroke, refers to the softening and necrosis of local brain tissue due to blood circulation disorders, ischemia, and hypoxia. According to the 2016 Stroke Epidemiology Report [4], there are currently 70 million stroke patients in my country, 2 million new strokes occur each year, and 1.65 million deaths due to stroke each year. There is one Chinese every 12 seconds. Stroke occurs, and one Chinese person dies of a stroke every 21 seconds. Chinese people who die from a stroke each year account for 22.45% of all deaths. According to the results of the study on the incidence and mortality of stroke in the Chinese population, stroke is currently the number one cause of death in China, accounting for 20% of deaths in urban populations and 19% in rural areas. Cerebral infarction is a disease with high morbidity, high disability, high mortality and high recurrence rate in China, and it has gradually attracted widespread attention from the whole society. Shuxuening injection is developed by Shiyao Yinhu Pharmaceutical Co., Ltd., and is a sterile aqueous solution made of ginkgo biloba or ginkgo biloba extract. The auxiliary materials are ethanol and vitamin C. Its main function is to expand blood vessels and improve microcirculation. It is used for ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism, cerebral vasospasm, etc. This trial is a randomized, double-blind, placebo-controlled multicenter clinical trial. The aim was to observe the effectiveness and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days, and to continue follow-up to 90 days after the onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Shuxuening injection + basic treatment |
|
| Control group | Placebo Comparator | placebo (sterilized water for injection) + basic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shuxinin injection | Drug | Shuxuening injection : 5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mRS score | Percentage of patients with mRS score ≤2 at 90 days post-onset. | baseline |
| mRS score | Percentage of patients with mRS score ≤2 at 90 days post-onset. | 10 days after treatment |
| mRS score | Percentage of patients with mRS score ≤2 at 90 days post-onset. | 30 days after onset |
| mRS score | Percentage of patients with mRS score ≤2 at 90 days post-onset. | 90 days after onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaogang Li | Contact | 13501095002 | xgangli2002@163.com | |
| Dongsheng Fan | Contact | 13701023871 |
| Name | Affiliation | Role |
|---|---|---|
| Xiaogang Li | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Basic treatment | Drug | Give oral aspirin enteric soluble tablets 150-300mg/d as early as possible after the onset of the disease, which can be changed to a prophylactic dose (50-325mg/d) after the acute phase. For those who cannot tolerate For those who cannot tolerate aspirin, clopidogrel can be used. |
|
| Placebo | Drug | sterilized water for injection,5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min. |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |