NCT02993367

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Second Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Cognitive Impairment no Dementia

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo Butylphthalide Soft Capsules

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-07-01
• First posted: 2016-12-15
• Last updated: 2017-03-16

Locations

1 site across 1 country: China