Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Cerebral Blood Flow
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in the scores of Montreal Cognitive Assessment
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged ≥ 40 years
- •≥ 50% stenosis in unilateral intracranial / carotid artery
- •Written informed consent available
Exclusion Criteria
- •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
Arms & Interventions
Control group
Placebo + Standard medical treatment
Intervention: Placebo
Intervention group
Nattokinase + standard medical treatment
Intervention: Nattokinase
Outcomes
Primary Outcomes
Changes in the scores of Montreal Cognitive Assessment
Time Frame: 6 months
Total score of 30
Secondary Outcomes
- Changes in metabonomics(6 months)
- Changes in the scores of Hopkins Verbal Learning Test(6 months)
- Changes in the scores of Animal Fluency Test(6 months)
- Changes in the scores of Olfactory stick test(6 months)
- Changes in the scores of clock drawing test(6 months)
- Changes in the scores of Mini-mental State Examination(6 months)
- Changes in cerebral blood flow in the territory of the culprit artery(6 months)
- Changes in cerebral glymphatic function(6 months)
- Changes in the scores of Colour Trail Test(6 months)
- Incidence of stroke event including ischemic and hemorrhagic stroke(6 months)