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

NCT05200234 | Unknown

• 1 other identifier: ICC-PACS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Blood Flow; Cognitive Function

Keywords

Intracranial / Carotid Stenosis; Cerebral Blood Flow; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Changes in the scores of Montreal Cognitive Assessment

  Total score of 30

  6 months

Secondary Outcomes (10)

• 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 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Nattokinase + standard medical treatment

Drug: Nattokinase

Control group

PLACEBO COMPARATOR

Placebo + Standard medical treatment

Drug: Placebo

Interventions

Nattokinase DRUG

Nattokinase + standard treatment

Intervention group

Placebo DRUG

Placebo+ standard treatment

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 40 years
• ≥ 50% stenosis in unilateral intracranial / carotid artery
• Written informed consent available

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Interventions

nattokinase

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 20, 2022
• Study Start: January 13, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)