The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua Tan granules is effective in the treatment of cognitive impairment after acute cerebral infarction .

Detailed Description
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The present study is designed to observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after Acute Cerebral Infarction, as well as study the patterns of syndrome evolution and neuropsychological characteristics, in order to provide evidences for the early-stage identification, diagnosis, intervention and treatment based on syndrome differentiation. To assess the effectiveness of applying early-stage prevention on patients with cognitive impairment after Acute Cerebral Infarction through the use of traditional Chinese medicine--Jian Pi Yi Shen Hua Tan granules, explore the pathogenesis and therapeutic efficacy mechanism, evaluate the effectiveness of early-stage prevention and provide alternative solutions for preventing or delaying dementia.

Official Title
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A Study to Evaluate the Safety and Efficacy of Jian Pi Yi Shen Hua Tan Granules in Patients With Cognitive Impairment After Acute Cerebral Infarction

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Drug: Jian Pi Yi Shen Hua Tan Granules
* Other: the placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients conform to the diagnostic criteria of acute ischemic stroke Online Certificate Status Protocol classification of cerebral infarction : Partial Anterior Circulation Infarct, Posterior Circulation Infarct or Lacunar Infarction - Stroke onset within 14 days Neuropsychological assessments: Montreal Cognitive Assessment Scale scores less than 26 points or scores less than 27 points，MMSE scores range from 19 points to 26 points Age from forty to eighty, gender not limited Informed and signed the informed consent Exclusion Criteria: Transient Ischemic Attack Online Certificate Status Protocol classification of cerebral infarction is a total anterior circulation infarction Stroke patients with the causes of cerebral hemorrhage, subarachnoid hemorrhage, brain tumors, brain injury, or blood diseases and so on. Stroke with an onset of more than 14 days Cerebral embolism caused by atrial fibrillation resulted from rheumatic heart disease, coronary heart disease and other heart diseases. Patients who cannot cooperate with the check due to serious visual, hearing dysfunction, apraxia, aphasia. Patients with other neurological diseases which can affect cognitive function (for example: severe Parkinson's disease, normal pressure hydrocephalus, brain tumors, encephalitis) Patients with communication difficulties, or psychiatric disease Depression (Hamilton Depression Scale scores more than or equal to 17 points) Diagnosed with alcohol or drug dependence within the past six months With other diseases which can cause cognitive dysfunction, Such as thyroid dysfunction, severe anemia, syphilis, Human Immunodeficiency Virus and so on With a previous history of stroke and serious sequelae, and cannot cope with neuropsychological examination With severe primary diseases, and cannot comply with the above scheme

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jian Pi Yi Shen Hua Tan Granules group<br>Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. | Drug: Jian Pi Yi Shen Hua Tan Granules<br>* 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<br>* Other names: Jianpi Yishen Huatan Granules group;|
| Placebo Comparator: the Placebo Group<br>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. | Other: the placebo group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mini-mental state examination | Using mini-mental state examination to examine the patients' cognitive function | 90 days | 
| Montreal Cognitive Assessment scale | Using Montreal Cognitive Assessment scale to examine the patients' cognitive function | 90 days | 
| Stroop test | Using Stroop test to examine executive function and attention | 90 days | 
| Numerical sequence test（DS-S) | Using Numerical sequence test（DS-S) to examine memeory | 90 days | 
| Digital color connection test (CCT) | Using Numerical sequence test（DS-S) to examine executive function and attention | 90 days | 
| Verbal memory test(HVLT) | Using Verbal memory test(HVLT) to examine verbal memory | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| national institute of health stroke scale | Using national institute of health stroke scale to examine the neurologic function impairment | 90 days | 
| modified Rankin scale | Using modified Rankin scale to examine the recovery of neurologic function | 90 days | 
| Activity of Daily Living Scale | Using Activity of Daily Living Scale to examine daily living ability | 90 days | 
| scores of Chinese medicine symptoms | Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention