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

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Jian Pi Yi Shen Hua Tan Granules
the placebo group
Sponsored by
Dongfang Hospital Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurology,Dongfang Hospital
  • Shunyi Hospital of Traditional Chinese Medicine
  • Chongqing Hospital of Traditional Chinese Medicine
  • Jiangmen Wuyi Hospital of Traditional Chinese Medicine
  • the Affiliated Hospital to Changchun University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jian Pi Yi Shen Hua Tan Granules group

the Placebo Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

mini-mental state examination
Using mini-mental state examination to examine the patients' cognitive function
Montreal Cognitive Assessment scale
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Stroop test
Using Stroop test to examine executive function and attention
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memeory
Digital color connection test (CCT)
Using Numerical sequence test（DS-S) to examine executive function and attention
Verbal memory test(HVLT)
Using Verbal memory test(HVLT) to examine verbal memory

Secondary Outcome Measures

national institute of health stroke scale
Using national institute of health stroke scale to examine the neurologic function impairment
modified Rankin scale
Using modified Rankin scale to examine the recovery of neurologic function
Activity of Daily Living Scale
Using Activity of Daily Living Scale to examine daily living ability
scores of Chinese medicine symptoms
Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom

Full Information

First Posted
December 13, 2015
Last Updated
July 18, 2019
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Changchun University of Chinese Medicine, Chongqing Traditional Chinese Medicine Hospital, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Shunyi Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02641886
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2016 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
April 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Changchun University of Chinese Medicine, Chongqing Traditional Chinese Medicine Hospital, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Shunyi Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jian Pi Yi Shen Hua Tan Granules group
Arm Type
Experimental
Arm Description
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Arm Title
the Placebo Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Jian Pi Yi Shen Hua Tan Granules
Other Intervention Name(s)
Jianpi Yishen Huatan Granules group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
the placebo group
Intervention Description
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
Primary Outcome Measure Information:
Title
mini-mental state examination
Description
Using mini-mental state examination to examine the patients' cognitive function
Time Frame
90 days
Title
Montreal Cognitive Assessment scale
Description
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Time Frame
90 days
Title
Stroop test
Description
Using Stroop test to examine executive function and attention
Time Frame
90 days
Title
Numerical sequence test（DS-S)
Description
Using Numerical sequence test（DS-S) to examine memeory
Time Frame
90 days
Title
Digital color connection test (CCT)
Description
Using Numerical sequence test（DS-S) to examine executive function and attention
Time Frame
90 days
Title
Verbal memory test(HVLT)
Description
Using Verbal memory test(HVLT) to examine verbal memory
Time Frame
90 days
Secondary Outcome Measure Information:
Title
national institute of health stroke scale
Description
Using national institute of health stroke scale to examine the neurologic function impairment
Time Frame
90 days
Title
modified Rankin scale
Description
Using modified Rankin scale to examine the recovery of neurologic function
Time Frame
90 days
Title
Activity of Daily Living Scale
Description
Using Activity of Daily Living Scale to examine daily living ability
Time Frame
90 days
Title
scores of Chinese medicine symptoms
Description
Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang, PhD,MD
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology,Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Facility Name
Shunyi Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101300
Country
China
Facility Name
Chongqing Hospital of Traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400011
Country
China
Facility Name
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Facility Name
the Affiliated Hospital to Changchun University of Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130103
Country
China

12. IPD Sharing Statement

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

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