Cognitive Impairment
Conditions
Keywords
traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention
Brief summary
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
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.
Interventions
DRUGJian Pi Yi Shen Hua Tan Granules
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
OTHERthe placebo group
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
Sponsors
Changchun University of Chinese Medicine
Chongqing Traditional Chinese Medicine Hospital
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Shunyi Hospital of Traditional Chinese Medicine
Dongfang Hospital Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal memory test(HVLT) | 90 days | Using Verbal memory test(HVLT) to examine verbal memory |
| Montreal Cognitive Assessment scale | 90 days | Using Montreal Cognitive Assessment scale to examine the patients' cognitive function |
| Stroop test | 90 days | Using Stroop test to examine executive function and attention |
| Numerical sequence test（DS-S) | 90 days | Using Numerical sequence test（DS-S) to examine memeory |
| Digital color connection test (CCT) | 90 days | Using Numerical sequence test（DS-S) to examine executive function and attention |
| mini-mental state examination | 90 days | Using mini-mental state examination to examine the patients' cognitive function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin scale | 90 days | Using modified Rankin scale to examine the recovery of neurologic function |
| Activity of Daily Living Scale | 90 days | Using Activity of Daily Living Scale to examine daily living ability |
| scores of Chinese medicine symptoms | 90 days | Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom |
| national institute of health stroke scale | 90 days | Using national institute of health stroke scale to examine the neurologic function impairment |
Countries
China
Outcome results
None listed