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

NCT02752867 | Unknown DMC

• 1 other identifier: 20140700108b
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

traditional Chinese medicine granules; Cognitive Impairment; Acute cerebral infraction; treatment

Outcome Measures

Primary Outcomes (8)

• 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.

  90 days

• 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.

  90 days

• Montreal Cognitive Assessment scale(MoCA)

  Using this scale to measure cognitive function

  90 days

• 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.

  90 days

• Numerical sequence test（DS-S)

  Using Numerical sequence test（DS-S) to examine memory

  90 days

• Digital color connection test (CCT)

  Using Digital color connection test (CCT) to examine executive function and attention

  90 days

• Verbal memory test(HVLT)

  Using Verbal memory test(HVLT) to examine verbal memory

  90 days

• Clinical Dementia Rating scale(CDR)

  Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia

  90 days

Secondary Outcomes (4)

• National institute of health stroke scale

  90 days

• Modified Rankin scale

  90 days

• Activity of Daily Living Scale

  90 days

• Scores of Chinese medicine symptoms

  90 days

Other Outcomes (7)

• whole blood cell test

  90 days

• routine urine test

  90 days

• Liver function

  90 days

Study Arms (2)

Jianpi Yishen Huatan Granules group

EXPERIMENTAL

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

Drug: Jianpi Yishen Huatan Granules

The control group

PLACEBO COMPARATOR

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

Interventions

Jianpi Yishen Huatan Granules 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

Also known as: Jianpi Yishen Huatan Granules group

Jianpi Yishen Huatan Granules group

the placebo 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

Also known as: the placebo group

The control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dongfang Hospital Beijing University of Chinese Medicine: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100078, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yunling Zhang

  Dongfang Hospital Beijing University of Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yunling Zhang, PhD,MD

CONTACT

+86 10 6768963; yunlingzhang2004@126.com

Yunling Zhang, PhD,MD

CONTACT

+86 10 67689634; yunlingzhang2004@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Dongfang Hospital

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: April 27, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)