Skip to content

Application of Fengyaokaixuan method on blood-brain barrier function and prognosis in patients with intracerebral hemorrhage by DCE-MRI

Application of Fengyaokaixuan method on blood-brain barrier function and prognosis in patients with intracerebral hemorrhage by DCE-MRI

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004360
Enrollment
Unknown
Registered
2020-10-30
Start date
2020-04-20
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

intracerebral hemorrhage

Interventions

Sponsors

Hospital (T.C.M) Affiliated to Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The cases are in accordance with the diagnostic criteria of hemorrhagic apoplexy in traditional Chinese medicine and cerebral hemorrhage in western medicine; (2) Aged 40 to 75 years old and the course of disease within 24 hours from the onset of the disease; (3) No serious dysfunction of heart, liver, kidney and blood system; (4) The site of hemorrhage: supratentorial and basal ganglia, and the hematoma did not break into the ventricle; (5) The volume of hematoma is below 30ml; (6) The (mRS) score of the modified Rankin scale was between 0 and 1 before onset, and the mRS score >=2 before entering the group; (7) Those who sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Secondary cerebral hemorrhage of various causes (including intracranial aneurysm rupture, arteriovenous malformation or tumor hemorrhage, drug-related cerebral hemorrhage, etc.); subarachnoid hemorrhage; mixed stroke; multifocal hemorrhage; basal ganglia hemorrhage breaking into the ventricle; cerebral hernia formation; midline structure shift more than 5mm; ipsilateral ventricular compression occlusion more than 1x2. The ipsilateral cistern and sulcus were blurred or disappeared, and the volume of hematoma was > 30ml; (2) Those with a history of cerebral hemorrhage in the past six months; (3) Patients with gastrointestinal bleeding; (4) There are serious complications, such as heart, liver and kidney insufficiency, hematopathy, malignant tumor and severe infection, mental patients and so on; (5) Pregnant or lactating women; (6) Those who are allergic to any of the drug ingredients in this scheme; (7) Those who need surgical treatment; (8) There are metal implants in the body, claustrophobia and other patients who can not complete MRI.

Design outcomes

Primary

MeasureTime frame
modified Rankin scale, mRS;

Secondary

MeasureTime frame
Glasgow Coma Scale, GCS;parameter of blood-brain barrier permeability, Ktrans;Barthel Index, BI;National Institute of Health stroke scale, NIHSS;Recurrence rate of cerebrovascular events;variation of intracranial hematoma;

Countries

China

Contacts

Public ContactBai Xue

Hospital (T.C.M) Affiliated to Southwest Medical University

bx7246@163.com+86 13909081756

Outcome results

None listed

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