drugset / Trial / NCT03804229
Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Butylphthalide | Small molecule | 200 mg | Oral |