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

February 25, 2019 updated by: Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100078
        • Recruiting
        • Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
        • Contact:
          • Yunling Zhang, PhD,MD
          • Phone Number: 86 10 67689634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Jianpi Yishen Huatan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Drug: 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
Other Names:
  • Jianpi Yishen Huatan Granules group
PLACEBO_COMPARATOR: 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.
Other: 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 Names:
  • the placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the fMRI outcome after the treatment
Time Frame: 90 days
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
90 days
Mini-mental state examination(MMSE)
Time Frame: 90 days
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
90 days
Montreal Cognitive Assessment scale(MoCA)
Time Frame: 90 days
Using this scale to measure cognitive function
90 days
Stroop Color- Word Association Test（Stroop test）
Time Frame: 90 days
This is a test used to find out the memory and executive function of patients.The test contains three small test.
90 days
Numerical sequence test（DS-S)
Time Frame: 90 days
Using Numerical sequence test（DS-S) to examine memory
90 days
Digital color connection test (CCT)
Time Frame: 90 days
Using Digital color connection test (CCT) to examine executive function and attention
90 days
Verbal memory test(HVLT)
Time Frame: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
90 days
Clinical Dementia Rating scale(CDR)
Time Frame: 90 days
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National institute of health stroke scale
Time Frame: 90 days
Using National institute of health stroke scale to measure the severity of stroke
90 days
Modified Rankin scale
Time Frame: 90 days
Using Modified Rankin scale to measure the recovery of neurological function
90 days
Activity of Daily Living Scale
Time Frame: 90 days
Using this scale to measure daily living ability
90 days
Scores of Chinese medicine symptoms
Time Frame: 90 days
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.
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
whole blood cell test
Time Frame: 90 days
blood routine test
90 days
routine urine test
Time Frame: 90 days
routine urine test
90 days
Liver function
Time Frame: 90 days
test the blood to detect the liver function,such as alanine aminotransferase(ALT) ,aspartate aminotransferase(AST),total bilirubin (TBIL), γ-glutamyl transferase(γ-GT).
90 days
electrocardiogram
Time Frame: 90 days
electrocardiograms are given before the experiment and on the 90th day of the experiment to test the condition of the patients' heart.
90 days
homocysteine
Time Frame: 90 days
detect the homocysteine in the blood
90 days
routine stool test
Time Frame: 90 days
examine stool of the patients
90 days
kidney function
Time Frame: 90 days
test the blood to detect the kidney function,such as blood urea nitrogen(BUN),creatinine (CRE),Uric acid(UA)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Investigators

  • Study Chair: Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140700108b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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