NCT02641886

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

December 13, 2015

Last Update Submit

July 18, 2019

Conditions

Cognitive Impairment

Keywords

traditional Chinese medicine granulesCognitive ImpairmentAcute cerebral infractionprevention

Outcome Measures

Primary Outcomes (6)

  • mini-mental state examination

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

    90 days

  • Montreal Cognitive Assessment scale

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

    90 days

  • Stroop test

    Using Stroop test to examine executive function and attention

    90 days

  • Numerical sequence test（DS-S)

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

    90 days

  • Digital color connection test (CCT)

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

    90 days

  • Verbal memory test(HVLT)

    Using Verbal memory test(HVLT) to examine verbal memory

    90 days

Secondary Outcomes (4)

  • national institute of health stroke scale

    90 days

  • modified Rankin scale

    90 days

  • Activity of Daily Living Scale

    90 days

  • scores of Chinese medicine symptoms

    90 days

Study Arms (2)

Jian Pi Yi Shen Hua Tan Granules group

EXPERIMENTAL

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

Drug: Jian Pi Yi Shen Hua Tan Granules

the Placebo Group

PLACEBO COMPARATOR

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

Interventions

Jian Pi Yi Shen Hua Tan GranulesDRUG

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

Also known as: Jianpi Yishen Huatan Granules group
Jian Pi Yi Shen Hua Tan Granules group
the placebo groupOTHER

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

the Placebo Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Neurology,Dongfang Hospital

Beijing, Beijing Municipality, 100078, China

Location

Shunyi Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 101300, China

Location

Chongqing Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, 400011, China

Location

Jiangmen Wuyi Hospital of Traditional Chinese Medicine

Jiangmen, Guangdong, 529000, China

Location

the Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, Jilin, 130103, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yunling Zhang, PhD,MD

    Dongfang Hospital Beijing University of Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Dongfang Hospital

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 30, 2015

Study Start

March 9, 2016

Primary Completion

January 18, 2019

Study Completion

April 18, 2019

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

CN(5)