Clinical Research of NBP Treating Ischemic Cerebrovascular Disease with Cognitive Impairment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000440

Enrollment

Unknown

Registered

2009-06-29

Start date

2008-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Ischemic cerebrovascular disease with cognitive impairment

Interventions

Treatment group:to give Butylphthalide soft capsules, 2 / time, 3 times / day, fasting

The control group:to give placebo, 2 / time, 3 times / day, fasting

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. More than 50 years old male or female; 2. Ischemic cerebrovascular disease history, imaging confirms vascular lesions (stroke lesions, white matter ischemic lesions); 3. Patients have cognitive dysfunction, dementia standard CDR score less than or equal to 0.5 hours of hospitalization or outpatient; 4. MMSE detection in line with the group of junior high school and above> 24 minutes, primary group>20 points, illiteracy group>17.

Exclusion criteria

Exclusion criteria: 1. Patients with decline of cognitive function before vascular disease occurs; 2. A family history of hereditary disease; 3. Suffering from any causes of consciousness; 4. Severe aphasia or physical disabilities and can not complete neuropsychological examinations; 5. Currently with depression (Hamilton Depression Rating Scale score> 8 points) or with mentally ill; 6. History of suffering from alcoholism, or history of drug addiction, or traumatic brain injury, epilepsy, encephalitis, hydrocephalus and normal intracranial pressure can cause cognitive impairment, such as the nervous system disease; 7. Suffering from systemic diseases that may lead to mild cognitive impairment (such as liver and kidney dysfunction, endocrine disease, vitamin deficiency); 8. Non-vascular cognitive impairment within 14 days of stroke onset; 9. Long-term use other drugs that influence safety or efficacy evaluation of tested drugs, such as: antipsychotics, antianxiety drugs, hypnotic, nootropic drugs (including traditional Chinese herbal medicine and pills); 10. Celery allergy; 11. Currently participating in the clinical research of other drugs.

Design outcomes

Primary

Measure	Time frame
ECG;Clinical examination;CIBIS, CIBIC-Plus;Collect adverse events and associated treatment;ADAS-Cog;Laboratory test;	—

Secondary

Measure	Time frame
CDR;NPI;ADL;MMSE;	—

Countries

China

Contacts

Public ContactJianping Jia

jiaxuanwu@126.com+86 10 81398730

Outcome results

None listed

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