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Study on the efficacy of butylphthalide in the treatment of cognitive impairment after delayed stroke: a randomized controlled trial.

A 24-week multicenter, randomized controlled study to evaluate the efficacy of NBP on Delayed-onset Post Stroke Cognitive Impairment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032555
Enrollment
Unknown
Registered
2020-05-02
Start date
2020-04-30
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Stroke Cognitive Impairment

Interventions

experimental group:Routine treatment and butylphthalide 200mg t.i.d
control group:Routine treatment

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 50-75 (including 50 and 75 years old) years, regardless of gender; 2. Patients who meet the diagnostic criteria of acute cerebral infarction in cerebrovascular disease group of Chinese Medical Association; 3. Patients with acute cerebral infarction supported by cranial MRI; 4. Patients with unconsciousness, obvious aphasia and severe limb paralysis who can complete the cognitive scale; 5. Subjects with primary school education and above who are able to complete cognitive function assessment; 6. The patient and his / her family members agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with acute cerebral infarction treated by intravenous or arterial thrombolysis or emergency intravascular intervention; 2. Patients with cerebral infarction secondary hemorrhage and hematoma; 3. Patients with cognitive impairment before cerebral infarction; 4. Patients with nervous system diseases, including neurodegenerative diseases (Alzheimer's disease, Parkinson's; disease, Lewy body dementia, frontotemporal dementia, etc.), optic neuritis, epilepsy, central nervous system infection (such as AIDS, syphilis, etc.), brain traumatic dementia, etc; 5. Psychotic patients, according to DSM-IV-TR standard, including schizophrenia or other mental diseases, bipolar disorder, major depression or delirium; 6. Patients who are using cholinesterase inhibitors, memantine or butylphthalide; 7. Patients with uncorrectable visual and auditory disorders who can not complete neuropsychological test and scale evaluation; 8. Patients with unstable or serious heart, lung, liver, kidney and hematopoietic system diseases; 9. Patients who can not be examined by MRI; 10. Patients who could not be followed up as required during the study.

Design outcomes

Primary

MeasureTime frame
magnetic resonance imaging;Cognitive and psychosomatic correlation scales;

Secondary

MeasureTime frame
Plasma inflammatory factor;

Countries

China

Contacts

Public ContactQu Qiumin

The First Affiliated Hospital of Xi'an Jiaotong University

quqiumin@126.com+86 29-85324083

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026