NCT04078204

A Clinical Study on the Treatment of Cerebral Small Vascular Disease

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Dl-3-Butylphthalide on the Treatment of Small Cerebral Vessel Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of butylphthalide (NBP) in the treatment of cerebral small vessel disease through a multicenter, randomized,double-blind, placebo-controlled study. Butylphthalide Soft Capsule and placebo were prescribed to the experimental group and the control group for a period of 24-months, respectively. After that, the experimental group and the control group were given Butylphthalide Soft Capsule for 6 months.

Detailed description

Butylphthalide can protect mitochondrial function and inhibit neuronal apoptosis by significantly increasing the activity of mitochondrial ATP complex enzyme and mitochondrial respiratory chain complex enzyme IV, improving the fluidity of mitochondrial membrane and maintaining mitochondrial membrane potential. Butylphthalide can reconstruct microcirculation and protect mitochondria, which can protect neurovascular units in an all-round way. Findings from previous studies have shown that butylphthalide can improve the ability of daily living of patients with ischemic cerebrovascular disease and can enhance cognitive function of patients diagnosed as subcortical vascular cognitive impairment no dementia.

Conditions

• Cerebral Small Vessel Diseases

Interventions

Type	Name	Description
DRUG	Butylphthalide Soft Capsules	The experimental group will receive the Butylphthalide Soft Capsules during the 24-month intervention period. After the 24-month intervention,The experimental group will receive Butylphthalide Soft Capsules for the 6-month open treatment period.
DRUG	placebo Soft Capsules	The placebo group will receive the Placebo Soft Capsules during the 24-month intervention period. After the 24-month intervention,The placebo group will receive Butylphthalide Soft Capsules for the 6-month open treatment period.

Timeline

• Start date: 2018-04-25
• Primary completion: 2022-02-01
• Completion: 2022-06-01
• First posted: 2019-09-04
• Last updated: 2019-09-04

Locations

1 site across 1 country: China