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A clinical study of dl-3-n-butylphthalide in improving the prognosis of patients with acute ischemic stroke

A clinical study of dl-3-n-butylphthalide in improving the prognosis of patients with acute ischemic stroke

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16010051
Enrollment
Unknown
Registered
2016-11-30
Start date
2016-12-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute ischemic stroke

Interventions

Experimental group:basic treatment+dl-3-n-butylphthalide injection 100ml, bid, 10d+dl-3-n-butylphthalide soft capsule 200mg, tid, 90d
control group:basic treatment

Sponsors

Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. first onset or history of stroke with mRSs=1, cerebral infarction in internal carotid artery system within 72h; 2. cerebral hemorrhage excluded by CT; 3. aged 18-80 years; 4. clear signs of nervous system orientation, NIHSS=20 (including minor stroke) 5. patients accepted clinical trial and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. diagnosed intracranial hemorrhagic by CT or suffering diseases with bleeding tendency; 2. cerebral infarction in vertebral basilar artery system; 3. liver dysfunction (aminotransferase exceeded the upper limit of the normal value of 1.5 times), renal dysfunction (Cr>2.0mg/dl or 177 µmol/L) or other severe systemic diseases, etc.; 4. concurrent malignancy or ongoing anti-tumor therapy; 5. allergic constitution, allergic to celery or dl-3-n-butylphthalide; 6. pregnant or lactating women; 7. Patients with dementia or mental disorders, or not considered suitable for this clinical study; 8. participating or participated in other clinical intervention studies within 90 days before receiving the informed consent.

Design outcomes

Primary

MeasureTime frame
rLMC;CBF;CBV;MTT;TTP;

Secondary

MeasureTime frame
mRS;MMSE;

Countries

China

Contacts

Public ContactYUN XU

Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing

xuyun20042001@aliyun.com+86 025 83105208

Outcome results

None listed

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