drugset / Trial / NCT03804229

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

NCT03804229

Phase 3 Active not recruiting 707 enrolled Capital Medical University CSPC-NBP Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Butylphthalide Small molecule 200 mg Oral

Indications