Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)

NCT ID: NCT05200234

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Blood Flow Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Nattokinase + standard medical treatment

Group Type EXPERIMENTAL

Nattokinase

Intervention Type DRUG

Nattokinase + standard treatment

Control group

Placebo + Standard medical treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo+ standard treatment

Interventions

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Nattokinase

Nattokinase + standard treatment

Intervention Type DRUG

Placebo

Placebo+ standard treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lou, PhD, MD

Role: CONTACT

13958007213

Facility Contacts

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Min Lou, PhD, MD

Role: primary

13958007213

Other Identifiers

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ICC-PACS

Identifier Type: -

Identifier Source: org_study_id

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