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The purpose of this study is to explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
The present study is designed to assess the efficacy and safety of Jianpi Yishen Huatan granules with cognitive impairment after Acute Cerebral Infarction by fMRI and neuropsychology scales,as well as observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after acute cerebral infarction.And explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
The sample size is 40 of which 20 are from the intervention group and 20 are from the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jianpi Yishen Huatan Granules group | Experimental | Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. |
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| The control group | Placebo Comparator | Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin and conventional treatment of ischemic stroke. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jianpi Yishen Huatan Granules | Drug | Jianpi Yishen Huatan Granules contain Herba cistanche，Fructus Alpinia Oxyphyllae，Rhodiola rosea, Polygala tenuifolia willd and Coptis chinensis.Jianpi Yishen Huatan Granules dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of treatment cycles: one |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the fMRI outcome after the treatment | Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment. | 90 days |
| Mini-mental state examination(MMSE) | MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc. | 90 days |
| Montreal Cognitive Assessment scale(MoCA) | Using this scale to measure cognitive function | 90 days |
| Stroop Color- Word Association Test（Stroop test） | This is a test used to find out the memory and executive function of patients.The test contains three small test. | 90 days |
| Numerical sequence test（DS-S) | Using Numerical sequence test（DS-S) to examine memory | 90 days |
| Digital color connection test (CCT) | Using Digital color connection test (CCT) to examine executive function and attention | 90 days |
| Verbal memory test(HVLT) | Using Verbal memory test(HVLT) to examine verbal memory | 90 days |
| Clinical Dementia Rating scale(CDR) |
| Measure | Description | Time Frame |
|---|---|---|
| National institute of health stroke scale | Using National institute of health stroke scale to measure the severity of stroke | 90 days |
| Modified Rankin scale | Using Modified Rankin scale to measure the recovery of neurological function |
| Measure | Description | Time Frame |
|---|---|---|
| whole blood cell test | blood routine test | 90 days |
| routine urine test | routine urine test | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunling Zhang, PhD,MD | Contact | +86 10 6768963 | yunlingzhang2004@126.com | |
| Yunling Zhang, PhD,MD | Contact | +86 10 67689634 | yunlingzhang2004@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunling Zhang | Dongfang Hospital Beijing University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100078 | China |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| the placebo | Other | Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin.The placebo dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of cycles: one |
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Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia |
| 90 days |
| 90 days |
| Activity of Daily Living Scale | Using this scale to measure daily living ability | 90 days |
| Scores of Chinese medicine symptoms | Scores of Chinese medicine symptoms, which is a scale resulted from literature research, the argumentation of experts and clinical observation,contain 23 items of the core symptoms of cognitive impairment. And the scale is used to measure the changes of symptoms of Chinese medicine before and after treatment. | 90 days |
| Liver function | test the blood to detect the liver function,such as alanine aminotransferase(ALT) ,aspartate aminotransferase(AST),total bilirubin (TBIL), γ-glutamyl transferase(γ-GT). | 90 days |
| electrocardiogram | electrocardiograms are given before the experiment and on the 90th day of the experiment to test the condition of the patients' heart. | 90 days |
| homocysteine | detect the homocysteine in the blood | 90 days |
| routine stool test | examine stool of the patients | 90 days |
| kidney function | test the blood to detect the kidney function,such as blood urea nitrogen(BUN),creatinine (CRE),Uric acid(UA) | 90 days |