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Effects of DL-3-n-butylphthalide capsule on collateral circulation and cognitive function in patients with chronic cerebral hypoperfusion: a multicenter, randomized, double-blind, controlled clinical trial

Effects of DL-3-n-butylphthalide capsule on collateral circulation and cognitive function in patients with chronic cerebral hypoperfusion: a multicenter, randomized, double-blind, controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059143
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-05-10
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

chronic cerebral hypoperfusion

Interventions

Experimental group:Take DL-3-n-butylphthalide capsules
Control group:Oral simulation agent of DL-3-n-butylphthalide capsules

Sponsors

The First Affiliated Hospital of Ji'nan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=45 years; 2. dCTA confirmed patients with unilateral carotid system (common carotid artery, internal carotid artery, middle cerebral artery) >=50% stenosis with hypoperfusion on the affected side, and contralateral vascular stenosis =6 months since the last stroke and NHISS score <=4 were included; 4.MMSE or MOCA scales indicate non-demented cognitive decline, with or without minor neurological focal symptoms and/or signs, including chronic dizziness, headache, insomnia, memory loss, and sleep disturbances; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cerebral ischemia attack in recent half a year, including transient ischemic attack and cerebral infarction; 2. History of cerebral hemorrhage, cerebral trauma, neurosurgery, etc., including history of hemorrhagic cerebral infarction; 3. Dementia, emotional disorders, schizophrenia or other neurological and mental diseases; 4. Evidence of cardiogenic embolism or non-atherosclerotic vascular lesions, such as dissection, moyamoya disease, or vasculitis; 5. Internal carotid artery or MCA stenting, balloon dilatation, endarterectomy, etc., were performed or intended to be performed during the test; 6. Patients with severe liver and kidney dysfunction, cardiac dysfunction, peripheral blood disease, malignant tumor history or undergoing antitumor therapy; 7. Those allergic to celery, butylphthalein and CT contrast agent in the past; 8. There is any language barrier to express feelings; 9. Pregnant or lactating patients; 10. Participated in or is participating in other clinical studies within the 3 months prior to the informed consent date.

Design outcomes

Primary

MeasureTime frame
Arteriovenous collateral circulation changed after DL-3-n-butylphthalide capsules soft capsule intervention;

Secondary

MeasureTime frame
Cortical venous filling (CVF) rate;Perfusion parameter;Evaluation of the degree of leukoencephalopathy;

Countries

China

Contacts

Public ContactHuang Li'an

The First Affiliated Hospital of Ji'nan University

tlian@jnu.edu.cn+86 13005199817

Outcome results

None listed

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