A Study to Evaluate the Safety and Efficacy of Jian Pi Yi Shen Hua Tan Granules in Patients With Cognitive Impairment After Acute Cerebral Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Numerical sequence test（DS-S)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Jian Pi Yi Shen Hua Tan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
干预措施: Jian Pi Yi Shen Hua Tan Granules (Drug)
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.
干预措施: the placebo group (Other)
结局指标
主要结局
Numerical sequence test（DS-S)
时间窗: 90 days
Using Numerical sequence test（DS-S) to examine memeory
Stroop test
时间窗: 90 days
Using Stroop test to examine executive function and attention
mini-mental state examination
时间窗: 90 days
Using mini-mental state examination to examine the patients' cognitive function
Montreal Cognitive Assessment scale
时间窗: 90 days
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Digital color connection test (CCT)
时间窗: 90 days
Using Numerical sequence test（DS-S) to examine executive function and attention
Verbal memory test(HVLT)
时间窗: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
次要结局
- national institute of health stroke scale(90 days)
- modified Rankin scale(90 days)
- Activity of Daily Living Scale(90 days)
- scores of Chinese medicine symptoms(90 days)
研究者
Yunling Zhang
President of Dongfang Hospital
Dongfang Hospital Beijing University of Chinese Medicine