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

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752867
• Other study ID #: 20140700108b
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: November 2019

Study information

• Verified date: February 2019
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Yunling Zhang, PhD,MD
• Phone: +86 10 6768963
• Email: yunlingzhang2004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Cognitive Impairment
• Infarction

Intervention

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:
• 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

Locations

Country	Name	City	State
China	Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	whole blood cell test	blood routine test	90 days
Other	routine urine test	routine urine test	90 days
Other	Liver function	test the blood to detect the liver function,such as alanine aminotransferase(ALT) ,aspartate aminotransferase(AST),total bilirubin (TBIL), ?-glutamyl transferase(?-GT).	90 days
Other	electrocardiogram	electrocardiograms are given before the experiment and on the 90th day of the experiment to test the condition of the patients' heart.	90 days
Other	homocysteine	detect the homocysteine in the blood	90 days
Other	routine stool test	examine stool of the patients	90 days
Other	kidney function	test the blood to detect the kidney function,such as blood urea nitrogen(BUN),creatinine (CRE),Uric acid(UA)	90 days
Primary	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
Primary	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
Primary	Montreal Cognitive Assessment scale(MoCA)	Using this scale to measure cognitive function	90 days
Primary	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
Primary	Numerical sequence test(DS-S)	Using Numerical sequence test(DS-S) to examine memory	90 days
Primary	Digital color connection test (CCT)	Using Digital color connection test (CCT) to examine executive function and attention	90 days
Primary	Verbal memory test(HVLT)	Using Verbal memory test(HVLT) to examine verbal memory	90 days
Primary	Clinical Dementia Rating scale(CDR)	Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia	90 days
Secondary	National institute of health stroke scale	Using National institute of health stroke scale to measure the severity of stroke	90 days
Secondary	Modified Rankin scale	Using Modified Rankin scale to measure the recovery of neurological function	90 days
Secondary	Activity of Daily Living Scale	Using this scale to measure daily living ability	90 days
Secondary	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.	90 days