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A Multi-center, Randomized, Double Blinding, Controlled Phase III Clinical Trial of Dl-3-Butylphthalide Injection in the Treatment of Acute Cerebral Infarct

A Multi-center, Randomized, Double Blinding, Controlled Phase III Clinical Trial of Dl-3-Butylphthalide Injection in the Treatment of Acute Cerebral Infarct

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000483
Enrollment
Unknown
Registered
2009-08-07
Start date
2007-03-01
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 Cerebral Infarct

Interventions

blank ozagrel, 100ml
Test Group A1:1-14 days, NBP injection 25mg/100ml
intravenous drip (styrene-NBP injecti on 50-70 minutes),2 times/day.15-90days,NBP soft capsules,100mg / pills, 2 / second, 2 times / day.Blank aspirin tablets.
Test Group A2:1-14 days, NBP injection 25mg/100ml
intravenous drip (NBP injection 50-70 minutes), 2 times/day, 15-90 days, aspirin tablets, 25mg / chip, 4 / time, 1 times / day.blank NBP soft capsules,2 / time, 2 times / day.
The control group B:1-14 days, a blank NBP injection 100ml
Ozagrel injection, 100ml: 80mg
intravenous drip (NBP injection 50-70 minutes), 2 times/day, between 6-8 hours. 15-90 days, aspirin tablets, 25mg / chip, 4 / time, 1 times / day.blank NBP soft capsules 2 / time, 2 times / day.

Sponsors

Beijing Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. First attack (or have a history of cerebral infarction but modified Rankin Scale (mRS) score in between 0-1 min); 2. Onset within 48 hours of the internal carotid system cerebral infarction; 3. CT examination excluded intracranial hemorrhage; 4. Patients aged 35 to 75 years; 5. There are clear signs of nervous system orientation, neurological deficit NIHSS score was 6 to 25 hours; 6. Before the start of the study, the patient or his legal representative has signed the "informed consent."

Exclusion criteria

Exclusion criteria: 1. CT head diseases seen in intracranial hemorrhage: cerebral hemorrhage, epidural hematoma, intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; 2. Vertebral - basilar artery system, cerebral infarction, a history of multiple lacunar infarction and leukoaraiosis or severe (able to judge the CT); 3.Or suspected cerebral embolism cerebral embolism in patients with atrioventricular block associated with disease, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, heart rate less than 50 times / min; 4. Awareness of severe obstacles: NIHSS level of awareness of the project 1a> 1 patient; 5.Transient ischemic attack (TIA); 6.With severe hypertension: systolic blood pressure>=200mmHg (26.6kPa) or diastolic blood pressure>=110mmHg (14.6kPa); 7. Tendency to suffer from hemorrhagic disease; 8. 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.; 9. Incidence of cerebral infarction after the use of therapeutic drugs: anticoagulant drugs (heparin, low molecular weight heparin, warfarin, etc.), thrombolytic drug (urokinase, t-PA, streptokinase, staphylokinase, etc.), anti-platelet drugs (Ozagrel, ticlopidine hydrochloride, dipyridamole, sarpogrelate hydrochloride esters, clopidogrel, etc), other (such as Batroxobin, lumbrokinase, Batroxobin, edaravone, gall CDP alkali, pentoxifylline); 10. Concurrent malignancy or ongoing anti-tumor treatment; 11. Past of celery, aspirin, study drug and control history of drug allergy or those who can not be tolerated; 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
National Institutes of Health Stroke Scale;

Secondary

MeasureTime frame
Barthel Index;Modified Rankin Scale;

Countries

China

Contacts

Public ContactLiying Cui
pumchcly@yahoo.com.cn+86 010 65296373

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026