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

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641886
• Other study ID #: 20140700108a
• Status: Completed
• Phase: N/A
• Start date: March 9, 2016
• Est. completion date: April 18, 2019

Study information

• Verified date: July 2019
• Source: Dongfang Hospital Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Cognitive Impairment
• Infarction

Intervention

Drug:
• Jian Pi Yi Shen Hua Tan 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 group
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

Locations

Country	Name	City	State
China	Department of Neurology,Dongfang Hospital	Beijing	Beijing
China	Shunyi Hospital of Traditional Chinese Medicine	Beijing	Beijing
China	the Affiliated Hospital to Changchun University of Chinese Medicine	Changchun	Jilin
China	Chongqing Hospital of Traditional Chinese Medicine	Chongqing	Chongqing
China	Jiangmen Wuyi Hospital of Traditional Chinese Medicine	Jiangmen	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Dongfang Hospital Beijing University of Chinese Medicine	Changchun University of Chinese Medicine, Chongqing Traditional Chinese Medicine Hospital, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Shunyi Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mini-mental state examination	Using mini-mental state examination to examine the patients' cognitive function	90 days
Primary	Montreal Cognitive Assessment scale	Using Montreal Cognitive Assessment scale to examine the patients' cognitive function	90 days
Primary	Stroop test	Using Stroop test to examine executive function and attention	90 days
Primary	Numerical sequence test(DS-S)	Using Numerical sequence test(DS-S) to examine memeory	90 days
Primary	Digital color connection test (CCT)	Using Numerical sequence test(DS-S) to examine executive function and attention	90 days
Primary	Verbal memory test(HVLT)	Using Verbal memory test(HVLT) to examine verbal memory	90 days
Secondary	national institute of health stroke scale	Using national institute of health stroke scale to examine the neurologic function impairment	90 days
Secondary	modified Rankin scale	Using modified Rankin scale to examine the recovery of neurologic function	90 days
Secondary	Activity of Daily Living Scale	Using Activity of Daily Living Scale to examine daily living ability	90 days
Secondary	scores of Chinese medicine symptoms	Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom	90 days