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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05200234

Collaborator

(none)

100

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Blood Flow Cognitive Function	Drug: Nattokinase Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 13, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Nattokinase + standard medical treatment	Drug: Nattokinase Nattokinase + standard treatment
Placebo Comparator: Control group Placebo + Standard medical treatment	Drug: Placebo Placebo+ standard treatment

Arm

Intervention/Treatment

Experimental: Intervention group

Nattokinase + standard medical treatment

Drug: Nattokinase

Nattokinase + standard treatment

Placebo Comparator: Control group

Placebo + Standard medical treatment

Drug: Placebo

Placebo+ standard treatment

Outcome Measures

Primary Outcome Measures

Changes in the scores of Montreal Cognitive Assessment [6 months]
Total score of 30

Secondary Outcome Measures

Changes in the scores of Mini-mental State Examination [6 months]
Total score of 30
Changes in cerebral blood flow in the territory of the culprit artery [6 months]
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 [6 months]
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Changes in metabonomics [6 months]
include blood and fecal samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affilated Hospital of Zhejiang University, School of Medicine	HangZhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05200234

Other Study ID Numbers:

ICC-PACS

First Posted:

Jan 20, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Intracranial / Carotid Stenosis

Cerebral Blood Flow

Cognitive Function

Additional relevant MeSH terms:

Carotid Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Apr 11, 2022