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NCT Number: NCT02641886

The Study of Jian Pi Yi Shen Hua Tan Granules in 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 .

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology,Dongfang Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jian Pi Yi Shen Hua Tan Granules

Drug

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

the placebo group

Other

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 outcomes

  1. mini-mental state examination

    Time frame: 90 days

    Using mini-mental state examination to examine the patients' cognitive function

  2. Montreal Cognitive Assessment scale

    Time frame: 90 days

    Using Montreal Cognitive Assessment scale to examine the patients' cognitive function

  3. Stroop test

    Time frame: 90 days

    Using Stroop test to examine executive function and attention

  4. Numerical sequence test（DS-S)

    Time frame: 90 days

    Using Numerical sequence test（DS-S) to examine memeory

  5. Digital color connection test (CCT)

    Time frame: 90 days

    Using Numerical sequence test（DS-S) to examine executive function and attention

  6. Verbal memory test(HVLT)

    Time frame: 90 days

    Using Verbal memory test(HVLT) to examine verbal memory

Secondary outcomes

  1. national institute of health stroke scale

    Time frame: 90 days

    Using national institute of health stroke scale to examine the neurologic function impairment

  2. modified Rankin scale

    Time frame: 90 days

    Using modified Rankin scale to examine the recovery of neurologic function

  3. Activity of Daily Living Scale

    Time frame: 90 days

    Using Activity of Daily Living Scale to examine daily living ability

  4. scores of Chinese medicine symptoms

    Time frame: 90 days

    Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom

Sponsors and collaborators

Lead sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 30, 2015
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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