The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction

Dongfang Hospital Beijing University of Chinese Medicine

Status: Completed

Conditions: Cognitive Impairment

Treatments: Other: the placebo group; Drug: Jian Pi Yi Shen Hua Tan Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT02641886

20140700108a

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Jian Pi Yi Shen Hua Tan Granules group

Experimental group

Description:

Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.

Treatment:

Drug: Jian Pi Yi Shen Hua Tan Granules

the Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Other: the placebo group