Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Nattokinase + standard medical treatment |
|
| Control group | Placebo Comparator | Placebo + Standard medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nattokinase | Drug | Nattokinase + standard treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the scores of Montreal Cognitive Assessment | Total score of 30 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the scores of Mini-mental State Examination | Total score of 30 | 6 months |
| Changes in cerebral blood flow in the territory of the culprit artery | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD, MD | Contact | 13958007213 | loumingxc@vip.sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo+ standard treatment |
|
| Changes in the scores of Colour Trail Test | 6 months |
| Changes in the scores of Hopkins Verbal Learning Test | 6 months |
| Changes in the scores of clock drawing test | 6 months |
| Changes in the scores of Animal Fluency Test | 6 months |
| Changes in the scores of Olfactory stick test | 6 months |
| Incidence of stroke event including ischemic and hemorrhagic stroke | 6 months |
| Changes in cerebral glymphatic function | assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index) | 6 months |
| Changes in metabonomics | include blood and fecal samples | 6 months |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053771 | nattokinase |
Not provided
Not provided
Not provided