An interventional study of Jian Pi Yi Shen Hua Tan Granules and the placebo group in Cognitive Impairment, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Completed at 5 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Not applicable, Interventional, and Prevention
The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua Tan granules is effective in the treatment of cognitive impairment after acute cerebral infarction .
The present study is designed to observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after Acute Cerebral Infarction, as well as study the patterns of syndrome evolution and neuropsychological characteristics, in order to provide evidences for the early-stage identification, diagnosis, intervention and treatment based on syndrome differentiation.
To assess the effectiveness of applying early-stage prevention on patients with cognitive impairment after Acute Cerebral Infarction through the use of traditional Chinese medicine--Jian Pi Yi Shen Hua Tan granules, explore the pathogenesis and therapeutic efficacy mechanism, evaluate the effectiveness of early-stage prevention and provide alternative solutions for preventing or delaying dementia.
813 studies on the registry are indexed under Cerebral Infarction; 181 are open to participants now.
This study's enrollment of 300 is above 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: Jian Pi Yi Shen Hua Tan 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 group
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
mini-mental state examination
Using mini-mental state examination to examine the patients' cognitive function
Time frame: 90 days
Montreal Cognitive Assessment scale
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Time frame: 90 days
Stroop test
Using Stroop test to examine executive function and attention
Time frame: 90 days
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memeory
Time frame: 90 days
Digital color connection test (CCT)
Using Numerical sequence test（DS-S) 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
national institute of health stroke scale
Using national institute of health stroke scale to examine the neurologic function impairment
Time frame: 90 days
modified Rankin scale
Using modified Rankin scale to examine the recovery of neurologic function
Time frame: 90 days
Activity of Daily Living Scale
Using Activity of Daily Living Scale to examine daily living ability
Time frame: 90 days
scores of Chinese medicine symptoms
Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom
Time frame: 90 days
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Dongfang Hospital Beijing University of Chinese Medicine