Cognitive ImpairmentNCT02752867
An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction
A study testing Jianpi Yishen Huatan Granules in people with Cognitive Impairment, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Jianpi Yishen Huatan Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients conform to the diagnostic criteria of acute ischemic stroke.
- The cerebral infarction area lies in the blood supply area of middle cerebral artery: basal ganglia,corona radiate region or other subcortical regions..
- The cumulative infarction area is no more than 3.0 cm.
- Stroke onset within 21 days
- Age from forty to eighty, gender not limited
- Neuropsychological assessments: Montreal Cognitive Assessment Scale scores less than 26 points or MMSE scores range from 19 points to 26 points in literates or MMSE scores range from 17 points to 24 points in illiterates
- Informed and signed the informed consent
Who cannot join
- Transient Ischemic Attack
- 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 21 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:Alzheimer's Disease，Parkinson's disease, frontotemporal dementia，Huntington's disease)
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- 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 trauma，tumor or infection of the central nervous system, metabolic disorders, normal pressure hydrocephalus , folic acid or vitamin B12 Deficiency, thyroid hypofunction,sever anemia,sever Parkinson's Disease, encephalitis, syphilis or HIV
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Yunling Zhang, PhD,MD, 86 10 67689634
About this study
Official title: Functional Magnetic Resonance Imaging Study to Explore the Mechanism and the Efficacy and Safety of Jianpi Yishen Huatan Granule for Cognitive Impairment After Acute Cerebral Infarction
The purpose of this study is to explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
Read the detailed description
The present study is designed to assess the efficacy and safety of Jianpi Yishen Huatan granules with cognitive impairment after Acute Cerebral Infarction by fMRI and neuropsychology scales,as well as observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after acute cerebral infarction.And explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
The sample size is 40 of which 20 are from the intervention group and 20 are from the control group.
- Conditions
- Cognitive Impairment
- Being tested
- Jianpi Yishen Huatan Granules, the placebo
- Keywords
- traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, treatment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianpi Yishen Huatan GranulesDrug
Also called Jianpi Yishen Huatan Granules group
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
the placeboOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Jianpi Yishen Huatan Granules group | Experimental | Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. Receives: Drug: Jianpi Yishen Huatan Granules |
| The control 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. Receives: Other: the placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the fMRI outcome after the treatment
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
Measured: 90 days
Mini-mental state examination(MMSE)
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
Measured: 90 days
Montreal Cognitive Assessment scale(MoCA)
Using this scale to measure cognitive function
Measured: 90 days
Stroop Color- Word Association Test（Stroop test）
This is a test used to find out the memory and executive function of patients.The test contains three small test.
Measured: 90 days
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memory
Measured: 90 days
Digital color connection test (CCT)
Using Digital color connection test (CCT) to examine executive function and attention
Measured: 90 days
Verbal memory test(HVLT)
Using Verbal memory test(HVLT) to examine verbal memory
Measured: 90 days
Clinical Dementia Rating scale(CDR)
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
Measured: 90 days
Secondary outcomes (4)
National institute of health stroke scale
Using National institute of health stroke scale to measure the severity of stroke
Measured: 90 days
Modified Rankin scale
Using Modified Rankin scale to measure the recovery of neurological function
Measured: 90 days
Activity of Daily Living Scale
Using this scale to measure daily living ability
Measured: 90 days
Scores of Chinese medicine symptoms
Scores of Chinese medicine symptoms, which is a scale resulted from literature research, the argumentation of experts and clinical observation,contain 23 items of the core symptoms of cognitive impairment. And the scale is used to measure the changes of symptoms of Chinese medicine before and after treatment.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Yunling Zhang, Study chair, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752867
- Sponsor's protocol ID
- 20140700108b
- Status last verified
- Feb 2019
- First submitted
- 20 Mar 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging Study to Explore the Mechanism and the Efficacy and Safety of Jianpi Yishen Huatan Granule for Cognitive Impairment After Acute Cerebral Infarction
- ClinicalTrials.gov ID
- NCT02752867
- Acronym / sponsor ID
- 20140700108b
- Conditions
- Cognitive Impairment
- Keywords
- traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
Detailed description
The present study is designed to assess the efficacy and safety of Jianpi Yishen Huatan granules with cognitive impairment after Acute Cerebral Infarction by fMRI and neuropsychology scales,as well as observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after acute cerebral infarction.And explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
The sample size is 40 of which 20 are from the intervention group and 20 are from the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jianpi Yishen Huatan Granules group | Experimental | Drug: Jianpi Yishen Huatan GranulesTreat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. |
| The control group | Placebo comparator | Other: the placeboTreat 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients conform to the diagnostic criteria of acute ischemic stroke.
- The cerebral infarction area lies in the blood supply area of middle cerebral artery: basal ganglia,corona radiate region or other subcortical regions..
- The cumulative infarction area is no more than 3.0 cm.
- Stroke onset within 21 days
- Age from forty to eighty, gender not limited
Key exclusion criteria (12 listed)
- Transient Ischemic Attack
- 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 21 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jianpi Yishen Huatan GranulesAlso: Jianpi Yishen Huatan Granules groupJianpi 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 | Drug | Jianpi Yishen Huatan Granules group |
| the placeboAlso: the placebo groupTreat 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 | Other | The control group |
Primary outcome
Changes of the fMRI outcome after the treatment
Time frame: 90 days
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
Mini-mental state examination(MMSE)
Time frame: 90 days
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
Montreal Cognitive Assessment scale(MoCA)
Time frame: 90 days
Using this scale to measure cognitive function
Stroop Color- Word Association Test（Stroop test）
Time frame: 90 days
This is a test used to find out the memory and executive function of patients.The test contains three small test.
Numerical sequence test（DS-S)
Time frame: 90 days
Using Numerical sequence test（DS-S) to examine memory
Digital color connection test (CCT)
Time frame: 90 days
Using Digital color connection test (CCT) to examine executive function and attention
Verbal memory test(HVLT)
Time frame: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
Clinical Dementia Rating scale(CDR)
Time frame: 90 days
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
4 secondary outcomes
National institute of health stroke scale
Time frame: 90 days
Modified Rankin scale
Time frame: 90 days
Activity of Daily Living Scale
Time frame: 90 days
Scores of Chinese medicine symptoms
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunling Zhang study chair
Dongfang Hospital Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jianpi Yishen Huatan Granules in people with Cognitive Impairment, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunling Zhang, PhD,MD (+86 10 6768963, yunlingzhang2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the fMRI outcome after the treatment (time frame: 90 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.