Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
Keywords
Abstract
Description
Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.
Dates
| Last Verified: | 09/30/2015 |
| First Submitted: | 02/06/2014 |
| Estimated Enrollment Submitted: | 02/06/2014 |
| First Posted: | 02/10/2014 |
| Last Update Submitted: | 06/15/2016 |
| Last Update Posted: | 06/19/2016 |
| Actual Study Start Date: | 05/31/2013 |
| Estimated Primary Completion Date: | 11/30/2016 |
| Estimated Study Completion Date: | 11/30/2016 |
Condition or disease
Intervention/treatment
Drug: Pinocembrin for Injection
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Pinocembrin for Injection 40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day | |
| Placebo Comparator: placebo 60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day |
Eligibility Criteria
| Ages Eligible for Study | 35 Years To 35 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 35-75 hospitalized patients - Patients with acute stroke ≤24h - NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6 - For the first time or always without obvious sequelae of stroke disease(mRS≤1） - Informed consent Exclusion Criteria: - The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms - Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study - TIA - Symptoms of disease rapidly improving during the randomized - Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg) - Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance <60ml/min） - Severe system or viscera organic disease - Have used other neuroprotectant or other experimental drugs - Patient who are unlikely to complete the study that due to a severe clinical condition - Pregnant or breast-feeding - Participation in a previous clinical study within 30 days - Meets all other exclusion criteria |
Outcome
Primary Outcome Measures
1. To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days [90 days]
Secondary Outcome Measures
1. To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. [90 days]
