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The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study

NCT02993367•The Second Hospital of Hebei Medical University

Summary

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.

Eligibility

Age

40 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Second Affiliated Hospital of Hebei medical university

Shijiazhuang, Hebei, China

Key Dates

Start Date

January 1, 2017

Primary Completion Date

January 1, 2019

Completion Date

July 1, 2019

Last Updated

March 16, 2017

Enrollment

200

ESTIMATED participants

Conditions

Vascular Cognitive Impairment no Dementia

Interventions

Butylphthalide Soft Capsules

DRUG

Placebo Butylphthalide Soft Capsules

DRUG

Contacts

Yifei Zhu, M.D.

CONTACT

+8613303046666 13831155688@163.com

Panpan Liang, M.D.

CONTACT

+8617717711528 2354672781@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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