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Multi-centers, Randomized, Double Blind, placebo parallel, Controlled Phase ? Clinical Trial of NBP and Sodium Chloride Injection in Treatment of Acute Cerebral Infarct

Multi-centers, Randomized, Double Blind, placebo parallel, Controlled Phase ? Clinical Trial of NBP and Sodium Chloride Injection in Treatment of Acute Cerebral Infarct

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003394
Enrollment
Unknown
Registered
2012-09-05
Start date
2013-08-01
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 Ischemic Stroke

Interventions

treatment group:Intravenous drop NBP Injection 25mg(100ml) at least 50 to 70 minutes each time and twice daily, at least 6 hours interval of between two drops, at least 14 days. From day 15 to day 90,
control group:Intravenous drop Blank NBP Injection 100ml every time, oral placebo butyl phthalide soft capsule. Others same as experimental group.

Sponsors

Department of Neurology, Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Onset within 48 hours of the internal carotid system cerebral infarction; 2. First attack 3. Patients aged 35 to 75 years of age; 4. There are clear signs of nervous system orientation, neurological deficit NIHSS score was 6 to 25 hours; 5. 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 hemorrhagesubarachnoid hemorrhage, etc.; 2. Awareness of severe obstacles: NIHSS level of awareness of the project 1a> 1 patient; 3. ischemic attack (TIA) 4. The patients who have been treated with thrombolysis and stent procedure ; 5. With severe hypertension: systolic blood pressure >=200mmHg (26.6kPa) or diastolic blood pressure >= 110mmHg (14.6kPa); 6. Tendency to suffer from hemorrhagic disease; 7. 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, such as; 8. Concurrent malignancy or ongoing anti-tumor treatment; 9. Past of celery,study drug and control history of drug allergy or those who can not be tolerated; 10. Pregnancy, lactation or pregnancy and planned pregnancy may be the patients; 11. Achieved in the prior informed consent within 3 months of participation in other clinical research, or are participating in other clinical stu dies; 12. Researchers think that is not suitable to participate in this clinical study of patients.

Design outcomes

Primary

MeasureTime frame
Change of Rankin scales (MRS);NIHSS score;EQ-5D;

Secondary

MeasureTime frame
Stroke mortality and recurrence rate;

Countries

China

Contacts

Public ContactCui LiYing
pumchcly@yahoo.com.cn+86 13701017357

Outcome results

None listed

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