Butyphthalide's effect on cognitive recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of dl-3-butylphthalide on cognitive function in patients who have experienced an acute ischemic stroke. Participants aged 60 and older will be assessed for cognitive impairment at least 12 weeks post-stroke, with a focus on those diagnosed with post-stroke cognitive impairment (PSCI). The study involves a randomized control design, comparing the effects of butyphthalide against a placebo. The goal is to determine if butyphthalide can improve cognitive outcomes in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

First stage:

* Acute ischemic stroke (AIS) symptom onset within 14 days Signs and symptoms consistent with the diagnosis of an acute ischemic stroke by CT/MRI.
* Age \>= 60 years，
* Baseline NIHSS 3-18.
* Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations
* Patient/legally authorized representative has signed the Informed Consent Form

Second stage:

* Patient with stage I diagnosis of PSCI.
* Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations.
* Patient/legally authorized representative has signed the Informed Consent Form

Exclusion Criteria:

First stage:

* Patients who had been diagnosed with dementia prior to stroke
* Other related factors affecting cognitive function: central nervous system infection, neurodegenerative diseases, trauma, poisoning, intracranial space occupying lesions, metabolic diseases, etc.
* Other serious central nervous system diseases: Parkinson's disease, epilepsy, multiple sclerosis, motor neurone disease, immune-related encephalomyelopathy, etc.
* Serious mental illness: anxiety disorder, depression, delirium, schizophrenia, bipolar disorder, mental retardation, which is diagnosed or controlled by medication.
* Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
* Severe liver and kidney dysfunction
* The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months.
* Current known alcohol or illicit drug abuse or dependence
* Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction.
* Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971).
* Allergic to any component of butylphthalein
* Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant
* Participants in other interventional clinical trials
* MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.)

Second stage:

* During the first phase of follow-up, participants' compliance was poor, with study medication compliance less than 80% or greater than 120%; Follow-up was less than 24 weeks or did not complete the follow-up within the follow-up window..
* Recurrent stroke in the first stage

Where it's running

• Donggang Center Hospitol
  Dandong, Liaoning, China Recruiting

Study contacts

• Study coordinator: Qiang Dong
• Email: dong_qiang@fudan.edu.cn
• Phone: +8602152887145

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.