The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND (EBSCPVCIND)

March 15, 2017 updated by: Yifei Zhu, The Second Hospital of Hebei Medical University

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study

Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Second Affiliated Hospital of Hebei medical university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Literate Han Chinese aged from 40 to 65 years
  • MMSE ≥24
  • Normal or slightly impaired activities of daily living

  • The MRI entry criteria are as follows:

    • Subcortical small infarcts (3-20 mm in diameter),or one or more strategically located subcortical small infarcts in the caudate nucleus globus pallidus, or thalamus
    • Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis); and
    • No hippocampal or entorhinal cortex atrophy (scored 0 according to medial temporal lobe atrophy scale of Scheltens)

Exclusion Criteria:

  • Patients with Diabetes mellitus
  • Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia
  • Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning
  • Known hypersensitivity to celery
  • Inability to undergo a brain MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: the Butylphthalide Soft Capsules group
600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
Drug: Butylphthalide Soft Capsules
DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.
PLACEBO_COMPARATOR: the placebo group
60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
Drug: Placebo Butylphthalide Soft Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of Cognitive function
Time Frame: Time points 0, 1, 3 and 6 months
Time points 0, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change of brain function
Time Frame: Time point at 0, 1, 3, 6 months
Time point at 0, 1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Hebei Medical University

Investigators

  • Principal Investigator: Yifei Zhu, M.D., The Second Hospital of Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYF55688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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