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

July 18, 2019 updated by: Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100078
        • Department of Neurology,Dongfang Hospital
      • Beijing, Beijing, China, 101300
        • Shunyi Hospital of Traditional Chinese Medicine
    • Chongqing
      • Chongqing, Chongqing, China, 400011
        • Chongqing Hospital of Traditional Chinese Medicine
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Jiangmen Wuyi Hospital of traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, China, 130103
        • The Affiliated Hospital To Changchun University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Jian Pi Yi Shen Hua Tan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
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 Names:
  • Jianpi Yishen Huatan Granules group
PLACEBO_COMPARATOR: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal memory test(HVLT)
Time Frame: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
90 days
mini-mental state examination
Time Frame: 90 days
Using mini-mental state examination to examine the patients' cognitive function
90 days
Montreal Cognitive Assessment scale
Time Frame: 90 days
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
90 days
Stroop test
Time Frame: 90 days
Using Stroop test to examine executive function and attention
90 days
Numerical sequence test（DS-S)
Time Frame: 90 days
Using Numerical sequence test（DS-S) to examine memeory
90 days
Digital color connection test (CCT)
Time Frame: 90 days
Using Numerical sequence test（DS-S) to examine executive function and attention
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
national institute of health stroke scale
Time Frame: 90 days
Using national institute of health stroke scale to examine the neurologic function impairment
90 days
modified Rankin scale
Time Frame: 90 days
Using modified Rankin scale to examine the recovery of neurologic function
90 days
Activity of Daily Living Scale
Time Frame: 90 days
Using Activity of Daily Living Scale to examine daily living ability
90 days
scores of Chinese medicine symptoms
Time Frame: 90 days
Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Collaborators

Chongqing Traditional Chinese Medicine Hospital
Changchun University of Chinese Medicine
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Shunyi Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2016

Primary Completion (ACTUAL)

January 18, 2019

Study Completion (ACTUAL)

April 18, 2019

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 25, 2015

First Posted (ESTIMATE)

December 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140700108a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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