The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

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

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Cognitive Impairment no Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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the Butylphthalide Soft Capsules group

600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months

Group Type EXPERIMENTAL

Butylphthalide Soft Capsules

Intervention Type DRUG

DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.

the placebo group

60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months

Group Type PLACEBO_COMPARATOR

Placebo Butylphthalide Soft Capsules

Intervention Type DRUG

Interventions

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Butylphthalide Soft Capsules

DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.

Intervention Type DRUG

Placebo Butylphthalide Soft Capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Literate Han Chinese aged from 40 to 65 years
* MMSE ≥24
* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No