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Chinese Assessment for Vinpocetine In Neurology

Shanghai Rxmidas Pharmaceuticals Co. Ltd. · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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Trial Title:The treatment of Vinpocetine(Cavinton)in patients with cerebral infarction, an open, randomized, multi-center control study 1. Objectives Evaluate the efficacy and safety of Vinpocetine(Cavinton)for treatment of cerebral infarction 2. Design Open, randomized, multi-center control study 3. Trial Population:Patients with acute cerebral infarction 4. Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited. 5. Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and Citicoline 0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day. Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day. 6. Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2 Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2 NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1 Serology, hepatic and renal function examination 6.3.2 Adverse events 7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
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