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

Primary Purpose

Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Jianpi Yishen Huatan Granules
the placebo
Sponsored by
Dongfang Hospital Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, treatment

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurology,Dongfang Hospital,Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jianpi Yishen Huatan Granules group

The control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes of the fMRI outcome after the treatment
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
Mini-mental state examination(MMSE)
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
Montreal Cognitive Assessment scale(MoCA)
Using this scale to measure cognitive function
Stroop Color- Word Association Test（Stroop test）
This is a test used to find out the memory and executive function of patients.The test contains three small test.
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memory
Digital color connection test (CCT)
Using Digital color connection test (CCT) to examine executive function and attention
Verbal memory test(HVLT)
Using Verbal memory test(HVLT) to examine verbal memory
Clinical Dementia Rating scale(CDR)
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia

Secondary Outcome Measures

National institute of health stroke scale
Using National institute of health stroke scale to measure the severity of stroke
Modified Rankin scale
Using Modified Rankin scale to measure the recovery of neurological function
Activity of Daily Living Scale
Using this scale to measure daily living ability
Scores of Chinese medicine symptoms
Scores of Chinese medicine symptoms, which is a scale resulted from literature research, the argumentation of experts and clinical observation,contain 23 items of the core symptoms of cognitive impairment. And the scale is used to measure the changes of symptoms of Chinese medicine before and after treatment.

Full Information

First Posted
March 20, 2016
Last Updated
February 25, 2019
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02752867
Brief Title
An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction
Official Title
Functional Magnetic Resonance Imaging Study to Explore the Mechanism and the Efficacy and Safety of Jianpi Yishen Huatan Granule for Cognitive Impairment After Acute Cerebral Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jianpi Yishen Huatan Granules group
Arm Type
Experimental
Arm Description
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Arm Title
The control group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Jianpi Yishen Huatan Granules
Other Intervention Name(s)
Jianpi Yishen Huatan Granules group
Intervention Description
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
Other
Intervention Name(s)
the placebo
Other Intervention Name(s)
the placebo group
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of the fMRI outcome after the treatment
Description
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
Time Frame
90 days
Title
Mini-mental state examination(MMSE)
Description
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
Time Frame
90 days
Title
Montreal Cognitive Assessment scale(MoCA)
Description
Using this scale to measure cognitive function
Time Frame
90 days
Title
Stroop Color- Word Association Test（Stroop test）
Description
This is a test used to find out the memory and executive function of patients.The test contains three small test.
Time Frame
90 days
Title
Numerical sequence test（DS-S)
Description
Using Numerical sequence test（DS-S) to examine memory
Time Frame
90 days
Title
Digital color connection test (CCT)
Description
Using Digital color connection test (CCT) to examine executive function and attention
Time Frame
90 days
Title
Verbal memory test(HVLT)
Description
Using Verbal memory test(HVLT) to examine verbal memory
Time Frame
90 days
Title
Clinical Dementia Rating scale(CDR)
Description
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
Time Frame
90 days
Secondary Outcome Measure Information:
Title
National institute of health stroke scale
Description
Using National institute of health stroke scale to measure the severity of stroke
Time Frame
90 days
Title
Modified Rankin scale
Description
Using Modified Rankin scale to measure the recovery of neurological function
Time Frame
90 days
Title
Activity of Daily Living Scale
Description
Using this scale to measure daily living ability
Time Frame
90 days
Title
Scores of Chinese medicine symptoms
Description
Scores of Chinese medicine symptoms, which is a scale resulted from literature research, the argumentation of experts and clinical observation,contain 23 items of the core symptoms of cognitive impairment. And the scale is used to measure the changes of symptoms of Chinese medicine before and after treatment.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
whole blood cell test
Description
blood routine test
Time Frame
90 days
Title
routine urine test
Description
routine urine test
Time Frame
90 days
Title
Liver function
Description
test the blood to detect the liver function,such as alanine aminotransferase(ALT) ,aspartate aminotransferase(AST),total bilirubin (TBIL), γ-glutamyl transferase(γ-GT).
Time Frame
90 days
Title
electrocardiogram
Description
electrocardiograms are given before the experiment and on the 90th day of the experiment to test the condition of the patients' heart.
Time Frame
90 days
Title
homocysteine
Description
detect the homocysteine in the blood
Time Frame
90 days
Title
routine stool test
Description
examine stool of the patients
Time Frame
90 days
Title
kidney function
Description
test the blood to detect the kidney function,such as blood urea nitrogen(BUN),creatinine (CRE),Uric acid(UA)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunling Zhang, PhD,MD
Phone
+86 10 6768963
Email
yunlingzhang2004@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunling Zhang, PhD,MD
Phone
+86 10 67689634
Email
yunlingzhang2004@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang, PhD,MD
Phone
86 10 67689634

12. IPD Sharing Statement

Plan to Share IPD
No

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

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