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ACTIVE NOT RECRUITING
NCT03804229
PHASE3

Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

Butylphthalide soft capsule has been confirmed to have beneficial effects for patients with vascular dementia (VaD) in clinical trial of phase II study. So the investigators hypothesize that Butylphthalide soft capsule may have same beneficial effects for patients with VaD in an extended samples in phase III study. In present study the investigators will recruit patients with mild to moderate VaD in a multi-center, random, double blind and placebo control methods to confirm the efficacy and safety of Butylphthalide soft capsule. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.

Official title: A Multi-center, Random, Double Blind and Placebo Control Phase III Clinical Study on the Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

707

Start Date

2019-10-29

Completion Date

2026-06-07

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Butylphthalide soft capsule

700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills(100mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.

DRUG

Placebo soft capsule

700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.

Locations (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China