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

NCT ID: NCT02752867

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Jianpi Yishen Huatan Granules group

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

Group Type EXPERIMENTAL

Jianpi Yishen Huatan Granules

Intervention Type 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

The control group

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.

Group Type PLACEBO_COMPARATOR

the placebo

Intervention Type 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

Interventions

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Jianpi Yishen Huatan 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

Intervention Type DRUG

the placebo

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

Intervention Type OTHER

Other Intervention Names

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Jianpi Yishen Huatan Granules group the placebo group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yunling Zhang

President of Dongfang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunling Zhang

Role: STUDY_CHAIR

Dongfang Hospital Beijing University of Chinese Medicine

Locations

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Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunling Zhang, PhD,MD

Role: CONTACT

+86 10 6768963

Yunling Zhang, PhD,MD

Role: CONTACT

+86 10 67689634

Facility Contacts

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Yunling Zhang, PhD,MD

Role: primary

86 10 67689634

Other Identifiers

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20140700108b

Identifier Type: -

Identifier Source: org_study_id

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