The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- change of Cognitive function
研究概览
简要总结
Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate Han Chinese aged from 40 to 65 years
- •Normal or slightly impaired activities of daily living
- •The MRI entry criteria are as follows:
- •Subcortical small infarcts (3-20 mm in diameter),or one or more strategically located subcortical small infarcts in the caudate nucleus globus pallidus, or thalamus
- •Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis); and
- •No hippocampal or entorhinal cortex atrophy (scored 0 according to medial temporal lobe atrophy scale of Scheltens)
排除标准
- •Patients with Diabetes mellitus
- •Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia
- •Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning
- •Known hypersensitivity to celery
- •Inability to undergo a brain MRI
研究组 & 干预措施
the Butylphthalide Soft Capsules group
600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
干预措施: Butylphthalide Soft Capsules (Drug)
the placebo group
60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
干预措施: Placebo Butylphthalide Soft Capsules (Drug)
结局指标
主要结局
change of Cognitive function
时间窗: Time points 0, 1, 3 and 6 months
次要结局
- change of brain function(Time point at 0, 1, 3, 6 months)
研究者
Yifei Zhu
Clinical Professor
The Second Hospital of Hebei Medical University