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

NCT03804229 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Vascular Dementia

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.

Sponsors & Collaborators

  • CSPC-NBP Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Jianping Jia, MD,PhD · Xuanwu Hospital of Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2024-10-23
Completion
2026-06-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03804229 on ClinicalTrials.gov