The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction
NCT ID: NCT02641886
Last Updated: 2019-07-19
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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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-03-09
2019-04-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Jian Pi Yi Shen Hua Tan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Jian 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
the Placebo 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 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
Interventions
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Jian 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
the 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Changchun University of Chinese Medicine
OTHER
Chongqing Traditional Chinese Medicine Hospital
OTHER
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
OTHER
Shunyi Hospital of Traditional Chinese Medicine
UNKNOWN
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, PhD,MD
Role: STUDY_CHAIR
Dongfang Hospital Beijing University of Chinese Medicine
Locations
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Department of Neurology,Dongfang Hospital
Beijing, Beijing Municipality, China
Shunyi Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangmen, Guangdong, China
the Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
Countries
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Other Identifiers
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20140700108a
Identifier Type: -
Identifier Source: org_study_id
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