An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction

Dongfang Hospital Beijing University of Chinese Medicine

Status: Unknown

Conditions: Cognitive Impairment

Treatments: Other: the placebo; Drug: Jianpi Yishen Huatan Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT02752867

20140700108b

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients conform to the diagnostic criteria of acute ischemic stroke.
• The cerebral infarction area lies in the blood supply area of middle cerebral artery: basal ganglia,corona radiate region or other subcortical regions..
• The cumulative infarction area is no more than 3.0 cm.
• Stroke onset within 21 days
• Age from forty to eighty, gender not limited
• Neuropsychological assessments: Montreal Cognitive Assessment Scale scores less than 26 points or MMSE scores range from 19 points to 26 points in literates or MMSE scores range from 17 points to 24 points in illiterates
• Informed and signed the informed consent

Exclusion criteria

• Transient Ischemic Attack
• 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 21 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:Alzheimer's Disease，Parkinson's disease, frontotemporal dementia，Huntington's disease)
• 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 trauma，tumor or infection of the central nervous system, metabolic disorders, normal pressure hydrocephalus , folic acid or vitamin B12 Deficiency, thyroid hypofunction,sever anemia,sever Parkinson's Disease, encephalitis, syphilis or HIV
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Jianpi Yishen Huatan Granules group

Experimental group

Description:

Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.

Treatment:

Drug: Jianpi Yishen Huatan Granules

The control group

Placebo Comparator group

Description:

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.

Treatment:

Other: the placebo