Cerebral Blood FlowICC-PACSNCT05200234
Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)
A study testing Nattokinase in people with Cerebral Blood Flow and Cognitive Function, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cerebral Blood Flow, Cognitive Function
- What is being tested?
- Nattokinase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
Who cannot join
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- severe loss of vision, hearing, or communicative ability
- plan to be treated with surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn
About this study
Official title: Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Patients in the intervention arm will be treated with standard medical treatment combined with Natto Products V, whereas Patient in the control arm will be treated with only standard medical treatment . And the impact of Natto Products V on improving cerebral blood flow and cognitive function in patients with asymptomatic intracranial / carotid stenosis will be assessed by neuropsychological scale and multimode magnetic resonance imaging.
- Conditions
- Cerebral Blood Flow, Cognitive Function
- Being tested
- Nattokinase, Placebo
- Keywords
- Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NattokinaseDrug
Nattokinase + standard treatment
PlaceboDrug
Placebo+ standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Nattokinase + standard medical treatment Receives: Drug: Nattokinase |
| Control group | Placebo comparator | Placebo + Standard medical treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the scores of Montreal Cognitive Assessment
Total score of 30
Measured: 6 months
Secondary outcomes (10)
Changes in the scores of Mini-mental State Examination
Total score of 30
Measured: 6 months
Changes in cerebral blood flow in the territory of the culprit artery
Measured: 6 months
Changes in the scores of Colour Trail Test
Measured: 6 months
Changes in the scores of Hopkins Verbal Learning Test
Measured: 6 months
Changes in the scores of clock drawing test
Measured: 6 months
Changes in the scores of Animal Fluency Test
Measured: 6 months
Changes in the scores of Olfactory stick test
Measured: 6 months
Incidence of stroke event including ischemic and hemorrhagic stroke
Measured: 6 months
Changes in cerebral glymphatic function
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Measured: 6 months
Changes in metabonomics
include blood and fecal samples
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start13 Jan 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood FlowStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200234
- Sponsor's protocol ID
- ICC-PACS
- Acronym
- ICC-PACS
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05200234
- Acronym / sponsor ID
- ICC-PACS / ICC-PACS
- Conditions
- Cerebral Blood Flow, Cognitive Function
- Keywords
- Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2022 (actual)
- 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.
A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Patients in the intervention arm will be treated with standard medical treatment combined with Natto Products V, whereas Patient in the control arm will be treated with only standard medical treatment . And the impact of Natto Products V on improving cerebral blood flow and cognitive function in patients with asymptomatic intracranial / carotid stenosis will be assessed by neuropsychological scale and multimode magnetic resonance imaging.
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 |
|---|---|---|
| Intervention group | Experimental | Drug: NattokinaseNattokinase + standard medical treatment |
| Control group | Placebo comparator | Drug: PlaceboPlacebo + Standard medical treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
Key exclusion criteria (5 listed)
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- severe loss of vision, hearing, or communicative ability
- plan to be treated with surgery
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 |
|---|---|---|
| NattokinaseNattokinase + standard treatment | Drug | Intervention group |
| PlaceboPlacebo+ standard treatment | Drug | Control group |
Primary outcome
Changes in the scores of Montreal Cognitive Assessment
Time frame: 6 months
Total score of 30
10 secondary outcomes
Changes in the scores of Mini-mental State Examination
Time frame: 6 months
Changes in cerebral blood flow in the territory of the culprit artery
Time frame: 6 months
Changes in the scores of Colour Trail Test
Time frame: 6 months
Changes in the scores of Hopkins Verbal Learning Test
Time frame: 6 months
Changes in the scores of clock drawing test
Time frame: 6 months
Changes in the scores of Animal Fluency Test
Time frame: 6 months
Changes in the scores of Olfactory stick test
Time frame: 6 months
Incidence of stroke event including ischemic and hemorrhagic stroke
Time frame: 6 months
Changes in cerebral glymphatic function
Time frame: 6 months
Changes in metabonomics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nattokinase in people with Cerebral Blood Flow and Cognitive Function, run by Second Affiliated Hospital, Zhejiang University, School of 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 3 inclusion and 5 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 18 Apr 2023. 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 Min Lou, PhD, MD (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the scores of Montreal Cognitive Assessment (time frame: 6 months). 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 18 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.