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EBSCPVCIND

UnknownPhase 2 / PHASE3

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

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

Asset

Butylphthalide

Listed sites

1

Recruiting sites

1

Enrollment

200

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•MMSE ≥24

Primary endpoint

•Cognitive function

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02993367
Org study IDZYF55688

Timeline

Milestones

Study first posted2016-12-15estimated
Study start2017-01actual (month precision)
Last update posted2017-03-16actual
Primary completion2019-01estimated (month precision)
Study completion2019-07estimated (month precision)

Assets

Drug assets

Butylphthalide

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Other (unclassified)
1

Global cognition

1 endpoint
Primary/protocol endpoint

change of Cognitive function

Time frame:Time points 0, 1, 3 and 6 months

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

change of brain function

Time frame:Time point at 0, 1, 3, 6 months

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.