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Clinical study on the difference of short-term and long-term efficacy of butylphthalide in acute ischemic stroke patients with different TOAST types

Clinical study on the difference of short-term and long-term efficacy of butylphthalide in acute ischemic stroke patients with different TOAST types

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040839
Enrollment
Unknown
Registered
2020-12-11
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Acute ischemic stroke

Interventions

Atherothrombosis:use of butylphthalide and routine treatment
Cardioembolism:use of butylphthalide and routine treatment
Small Artery Disease:use of butylphthalide and routine treatment
Stroke of Other Determined Etiology:use of butylphthalide and routine treatment
Stroke of Undetermined Etiology:use of butylphthalide and routine treatment

Sponsors

People's Hospital of Xinjiang Uygur Autounomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) First onset or history of stroke with mRSs <= 1; 2) Cerebral infarction in internal carotid artery system within 48h; 3) Aged 35-75 years; 4) Clear signs of nervous system orientation,4 <= NIHSS < 20 (including minor stroke); 5) Subjects have unconscious disturbance, check cooperation and normal swallowing function; 6) Before the start of the study, the patient himself or his legal representative had signed the "Informed Consent".

Exclusion criteria

Exclusion criteria: 1) CT head diseases seen in intracranial hemorrhage: intraventricular hemorrhage, subarachnoid hemorrhage, etc.; 2) Awareness of severe obstacles: NIHSS level of awareness of the project 1a > 1 patient; 3) Transient ischemic attack (TIA); 4) After the onset, undergo thrombolysis and stent surgery; 5) With severe hypertensionand poor control, higher than the level 3 hypertension (currently defined as the level 3 hypertensionsystolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg); 6) Tendency to suffer from hemorrhagic disease; 7) Pseudobulbar palsy with dysphagia; 8) Patients with gastrointestinal diseases that seriously affect drug absorption; 9) Liver dysfunction (transaminases more than 1.5 times the upper limit of normal), renal dysfunction (Cre> 2.0mg/dl or 177umol/L), cardiac dysfunction or suffering from other serious systemic diseases, et al.; 10) Concurrent malignancy or ongoing anti-tumor treatment; 11) Patients with allergic constitution are allergic to celery and butylphthalide; 12) Pregnancy, lactation or pregnancy and planned pregnancy may be the patients; 13) Achieved in the prior informed consent within 3 months of participation in other clinical research, or are participating in other clinical studies; 14) Researchers think that is not suitable to participate in this clinical study of patients.

Design outcomes

Primary

MeasureTime frame
mRS;

Secondary

MeasureTime frame
NIHSS;Barthel;recurrence and mortality outcomes rates;

Countries

China

Contacts

Public ContactHongyan LI

People's Hospital of Xinjiang Uygur Autounomous Region

1170401724@qq.com+86 13659942323

Outcome results

None listed

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