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
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-12-31
2019-11-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
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
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.
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Dongfang Hospital Beijing University of Chinese Medicine
OTHER
Responsible Party
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Yunling Zhang
President of Dongfang Hospital
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
Countries
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Central Contacts
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Facility Contacts
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Yunling Zhang, PhD,MD
Role: primary
Other Identifiers
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20140700108b
Identifier Type: -
Identifier Source: org_study_id
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