Clinical Trial

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

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-01-11; most recent amendment 2026-03-19.
Status change: Recruiting → Active, Not Recruiting 2023-10-29
Status change: Not Yet Recruiting → Recruiting 2019-10-28
Trial Details
NCT Number NCT03804229
Lead Sponsor Capital Medical University
Collaborators: CSPC-NBP Pharmaceutical Co., Ltd.
Conditions Vascular Dementia
Enrollment 707 participants
Start Date 2019-10-29
Primary Completion 2024-10-23 (estimated)
Study Completion 2026-06-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-23