Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in the scores of Montreal Cognitive Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 40 years
- •≥ 50% stenosis in unilateral intracranial / carotid artery
- •Written informed consent available
排除标准
- •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
研究组 & 干预措施
Control group
Placebo + Standard medical treatment
干预措施: Placebo (Drug)
Intervention group
Nattokinase + standard medical treatment
干预措施: Nattokinase (Drug)
结局指标
主要结局
Changes in the scores of Montreal Cognitive Assessment
时间窗: 6 months
Total score of 30
次要结局
- 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)