Clinical trial NCT02641886: The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: traditional Chinese medicine granules
Cognitive Impairment
Acute cerebral infraction
prevention
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Changchun University of Chinese Medicine
name: Chongqing Traditional Chinese Medicine Hospital
name: Jiangmen Wuyi Hospital of Traditional Chinese Medicine
name: Shunyi Hospital of Traditional Chinese Medicine
First posted: 2015-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: mini-mental state examination
timeFrame: 90 days
measure: Montreal Cognitive Assessment scale
timeFrame: 90 days
measure: Stroop test
timeFrame: 90 days
measure: Numerical sequence test（DS-S)
timeFrame: 90 days
measure: Digital color connection test (CCT)
timeFrame: 90 days
measure: Verbal memory test(HVLT)
timeFrame: 90 days
Secondary outcomes:
measure: national institute of health stroke scale
timeFrame: 90 days
measure: modified Rankin scale
timeFrame: 90 days
measure: Activity of Daily Living Scale
timeFrame: 90 days
measure: scores of Chinese medicine symptoms
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology,Dongfang Hospital
state: Beijing
city: Beijing
country: China
facility: Shunyi Hospital of Traditional Chinese Medicine
state: Beijing
city: Chongqing
country: China
facility: Chongqing Hospital of Traditional Chinese Medicine
state: Chongqing
city: Jiangmen
country: China
facility: Jiangmen Wuyi Hospital of Traditional Chinese Medicine
state: Guangdong
city: Changchun
country: China
facility: the Affiliated Hospital to Changchun University of Chinese Medicine
state: Jilin
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Yunling Zhang, PhD,MD
role: STUDY_CHAIR
References: