An interventional study of Jianpi Yishen Huatan Granules and the placebo in Cognitive Impairment, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
813 studies on the registry are indexed under Cerebral Infarction; 181 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 532 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →Dongfang Hospital Beijing University of Chinese Medicine is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Drug: Jianpi Yishen Huatan Granules
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
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
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
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.
Time frame: 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.
Time frame: 90 days
Montreal Cognitive Assessment scale(MoCA)
Using this scale to measure cognitive function
Time frame: 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.
Time frame: 90 days
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memory
Time frame: 90 days
Digital color connection test (CCT)
Using Digital color connection test (CCT) to examine executive function and attention
Time frame: 90 days
Verbal memory test(HVLT)
Using Verbal memory test(HVLT) to examine verbal memory
Time frame: 90 days
Clinical Dementia Rating scale(CDR)
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
Time frame: 90 days
National institute of health stroke scale
Using National institute of health stroke scale to measure the severity of stroke
Time frame: 90 days
Modified Rankin scale
Using Modified Rankin scale to measure the recovery of neurological function
Time frame: 90 days
Activity of Daily Living Scale
Using this scale to measure daily living ability
Time frame: 90 days
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.
Time frame: 90 days
whole blood cell test
blood routine test
Time frame: 90 days
routine urine test
routine urine test
Time frame: 90 days
Liver function
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
electrocardiogram
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
homocysteine
detect the homocysteine in the blood
Time frame: 90 days
routine stool test
examine stool of the patients
Time frame: 90 days
kidney function
test the blood to detect the kidney function,such as blood urea nitrogen(BUN),creatinine (CRE),Uric acid(UA)
Time frame: 90 days
Plan to share: No
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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Dongfang Hospital Beijing University of Chinese Medicine