Cognitive ImpairmentNCT02641886
The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction
A study testing Jian Pi Yi Shen Hua Tan Granules in people with Cognitive Impairment, run by Dongfang Hospital Beijing University of Chinese Medicine at 5 sites in China.
Trial 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 . 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?
- Jian Pi Yi Shen Hua Tan Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 9 Mar 2016to 18 Apr 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 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Department of Neurology,Dongfang Hospital
Beijing, Beijing Municipality, 100078
Shunyi Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 101300
the Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, 130103
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, 400011
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangmen, Guangdong, 529000
About this study
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
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 .
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Jian Pi Yi Shen Hua Tan Granules, the placebo group
- Keywords
- traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jian Pi Yi Shen Hua Tan 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 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
| Study group | Role | What they receive |
|---|---|---|
| Jian Pi Yi Shen Hua Tan Granules group | Experimental | Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. Receives: 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. Receives: Other: the placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mini-mental state examination
Using mini-mental state examination to examine the patients' cognitive function
Measured: 90 days
Montreal Cognitive Assessment scale
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Measured: 90 days
Stroop test
Using Stroop test to examine executive function and attention
Measured: 90 days
Numerical sequence test（DS-S)
Using Numerical sequence test（DS-S) to examine memeory
Measured: 90 days
Digital color connection test (CCT)
Using Numerical sequence test（DS-S) 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
Secondary outcomes (4)
national institute of health stroke scale
Using national institute of health stroke scale to examine the neurologic function impairment
Measured: 90 days
modified Rankin scale
Using modified Rankin scale to examine the recovery of neurologic function
Measured: 90 days
Activity of Daily Living Scale
Using Activity of Daily Living Scale to examine daily living ability
Measured: 90 days
scores of Chinese medicine symptoms
Using the scores of Chinese medicine symptoms to examine the Chinese medicine syndrom
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 posted30 Dec 2015 (estimated)
- Study start9 Mar 2016
- Primary completion18 Jan 2019
- Study completion18 Apr 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Yunling Zhang, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Yunling Zhang, PhD,MD, Study chair, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641886
- Sponsor's protocol ID
- 20140700108a
- Status last verified
- Jul 2019
- First submitted
- 13 Dec 2015
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02641886
- Acronym / sponsor ID
- 20140700108a
- Conditions
- Cognitive Impairment
- Keywords
- traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or 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
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 30 Dec 2015 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jian Pi Yi Shen Hua Tan Granules group | Experimental | Drug: Jian Pi Yi Shen Hua Tan GranulesTreat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. |
| the Placebo Group | Placebo comparator | Other: the placebo groupTreat 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 (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Jian Pi Yi Shen Hua Tan 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 | Jian Pi Yi Shen Hua Tan Granules group |
| 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 Placebo Group |
Primary outcome
mini-mental state examination
Time frame: 90 days
Using mini-mental state examination to examine the patients' cognitive function
Montreal Cognitive Assessment scale
Time frame: 90 days
Using Montreal Cognitive Assessment scale to examine the patients' cognitive function
Stroop test
Time frame: 90 days
Using Stroop test to examine executive function and attention
Numerical sequence test（DS-S)
Time frame: 90 days
Using Numerical sequence test（DS-S) to examine memeory
Digital color connection test (CCT)
Time frame: 90 days
Using Numerical sequence test（DS-S) to examine executive function and attention
Verbal memory test(HVLT)
Time frame: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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, PhD,MD study chair
Dongfang Hospital Beijing University of Chinese Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jian Pi Yi Shen Hua Tan Granules in people with Cognitive Impairment, run by Dongfang Hospital Beijing University of Chinese Medicine at 5 sites 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 4 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: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mini-mental state examination (time frame: 90 days). The study lists 6 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 19 Jul 2019.