NCT02752867

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cognitive Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-08-01
• Completion: 2019-11-01
• First posted: 2016-04-27
• Last updated: 2019-02-26

Locations

1 site across 1 country: China