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The effect of butylphthalide treatment on cerebral perfusion and cognitive function in patients with vascular dementia

The effect of butylphthalide treatment on cerebral perfusion and cognitive function in patients with vascular dementia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056012
Enrollment
Unknown
Registered
2022-01-30
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Vascular Dementia

Interventions

Butylphthalide Group:Oral butylphthalide capsule 0.2g/time, 3 times/day for 90 days
None Butylphthalide Group:without butylphthalide

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 50 years, = 6 years; 3.Meet the diagnostic criteria for vascular cognitive dysfunction of the Diagnostic and Statistical Manual of Mental Diseases (5th Edition); 4.MRI supports the existence of ischemic cerebrovascular disease, which is in line with NINDS-AIREN imaging diagnostic criteria; 5.If there was a clear history of stroke, they were enrolled 3 months after the last stroke. If there is no clear history of stroke, the group can be enrolled if other conditions are met; 6.Patients with mild and moderate vascular dementia, 11 <= MMSE <= 26 and 1 <= CDR <= 2; 7.The total score of Hamilton Depression Scale (HAMD) <= 17; 8.The patient himself or his legal guardian agrees to participate in the trial and signs the informed consent before the trial; 9.Have caregivers and accompany patients for at least 4 days a week, more than 4 hours a day, and can accompany patients to each visit.

Exclusion criteria

Exclusion criteria: 1.Dementia caused by other brain diseases other than VaD (such as Alzheimer's disease, Louis's disease, frontotemporal dementia, Parkinson's disease, demyelinating disease of central nervous system, tumor, hydrocephalus, trauma, syphilis, AIDS, Creutzfeldt Jakob disease, etc.) 2.Those who cannot complete the examination due to severe neurological deficit, such as convenient hand hemiplegia, various aphasia, audio-visual disorder, etc; 3.Unable to swallow oral drugs, or suffering from diseases affecting the absorption of oral drugs, such as active bowel disease, partial or complete intestinal obstruction, etc; 4.Serious circulatory, respiratory, urinary, digestive and hematopoietic diseases (such as unstable angina pectoris, uncontrollable asthma, active gastric bleeding, etc.) and cancer; 5.Nutritional and metabolic diseases and endocrine system diseases: thyroid diseases, parathyroid diseases and vitamin or other element deficiency; 6.Serious mental illness (such as depression, schizophrenia) and epilepsy; 7.Alcohol and drug abuse; 8.Those with a history of familial dementia; 9.Drugs affecting cognitive function, such as cholinesterase inhibitors, memantine, cholinergic drugs, antipsychotics, anti anxiety drugs, hypnotics and intelligence promoting drugs (including traditional Chinese herbs and pills, such as Cistanche yizhi capsule, Jiannaoan, etc.); 10.Patients who had used butylphthalide soft capsule or injection within two weeks before enrollment; 11.Allergic to butylphthalide/celery; 12.Patients with severe bleeding tendency and liver dysfunction (transaminase exceeds the upper limit of normal value by 3 times); 13.Pregnant and lactating women; 14.Those who participated in other intervention clinical studies within 3 months before enrollment; 15.Unable to perform MRI cranial imaging.

Design outcomes

Primary

MeasureTime frame
Vascular dementia assessment scale-cog;

Countries

China

Contacts

Public ContactLin Yufeng

Tianjin First Central Hospital

13752451956@163.com+86 13752451956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026