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Efficacy and Safety Analysis of Butylphthalide Soft Capsules in Secondary Prevention of Stroke: a Real-World Study

Efficacy and Safety Analysis of Butylphthalide Soft Capsules in Secondary Prevention of Stroke: a Real-World Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034481
Enrollment
Unknown
Registered
2020-07-06
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Ischemic stroke

Interventions

experimental group:use of butylphthalide and routine secondary prophylaxis
control group: routine secondary prophylaxis

Sponsors

Northwest University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient's age > 18 years; 2. Hospitalized patients with ischemic stroke diagnosed by clinical symptoms or signs. The clinical manifestations are the symptoms and characteristics of sudden onset, rapid occurrence of localized or diffuse brain damage, and the defect of neurological function is consistent with the distribution of blood vessels. 3. 24 hours after admission, there were neurological examination results and imaging (CT/CTA, MRI/MRA) changes. 4. Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who were discharged from hospital, transferred to other departments and died within 24 hours. 2. Patients with severe heart, liver, kidney and other organ dysfunction or severe systemic diseases are expected to survive for less than one year. 3. Patients cannot be followed up continuously. 4. Hepatic and renal dysfunction. 5. Allergic to butylphthalide. 6. Patients during pregnancy, lactation and planned pregnancy. 7. Patients with severe mental disorders and dementia.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of stroke;

Secondary

MeasureTime frame
NIHSS;mRS;clinical cardiovascular events;Adverse reaction;

Countries

China

Contacts

Public ContactZhao Gang

Air Force Military Medical University

zhaogang@fmmu.com+86 13335389590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026