The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction
- Conditions
- Cognitive Impairment
- Interventions
- Drug: Jian Pi Yi Shen Hua Tan GranulesOther: the placebo group
- Registration Number
- NCT02641886
- Lead Sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Brief Summary
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 .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Patients conform to the diagnostic criteria of acute ischemic stroke Online Certificate Status Protocol classification of cerebral infarction : Partial Anterior Circulation Infarct, Posterior Circulation Infarct or Lacunar Infarction - Stroke onset within 14 days
- Neuropsychological assessments: Montreal Cognitive Assessment Scale scores less than 26 points or scores less than 27 points，MMSE scores range from 19 points to 26 points
- Age from forty to eighty, gender not limited
- Informed and signed the informed consent
- Transient Ischemic Attack
- Online Certificate Status Protocol classification of cerebral infarction is a total anterior circulation infarction
- 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 14 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: severe Parkinson's disease, normal pressure hydrocephalus, brain tumors, encephalitis)
- 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 thyroid dysfunction, severe anemia, syphilis, Human Immunodeficiency Virus and so on
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jian Pi Yi Shen Hua Tan Granules group Jian Pi Yi Shen Hua Tan Granules Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. the Placebo Group the placebo group 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.
- Primary Outcome Measures
Name Time Method Numerical sequence test（DS-S) 90 days Using Numerical sequence test（DS-S) to examine memeory
Stroop test 90 days Using Stroop test to examine executive function and attention
mini-mental state examination 90 days Using mini-mental state examination to examine the patients' cognitive function
Montreal Cognitive Assessment scale 90 days Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Digital color connection test (CCT) 90 days Using Numerical sequence test（DS-S) to examine executive function and attention
Verbal memory test(HVLT) 90 days Using Verbal memory test(HVLT) to examine verbal memory
- Secondary Outcome Measures
Name Time Method national institute of health stroke scale 90 days Using national institute of health stroke scale to examine the neurologic function impairment
modified Rankin scale 90 days Using modified Rankin scale to examine the recovery of neurologic function
Activity of Daily Living Scale 90 days Using Activity of Daily Living Scale to examine daily living ability
scores of Chinese medicine symptoms 90 days Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom
Trial Locations
- Locations (5)
Shunyi Hospital of Traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
🇨🇳Jiangmen, Guangdong, China
the Affiliated Hospital to Changchun University of Chinese Medicine
🇨🇳Changchun, Jilin, China
Department of Neurology,Dongfang Hospital
🇨🇳Beijing, Beijing, China
Chongqing Hospital of Traditional Chinese Medicine
🇨🇳Chongqing, Chongqing, China