A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
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Status:
This study has been completed. Plans to publish results from this study are still underway as of October 2009.
Purpose:
To evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.
Interventions:
Aspirin
Antiplatelet agent; inhibits thromboxane A2; antipyretic
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EGb761
Cerebral and systemic vessel dilator with action on arteries, capillaries and venas. Its action is due to the flavonoids it contains. Improves cerebral circulation and oxygen and glucosis utilization by neurons. Captures and inactivates the free radicals, protecting the lipids, phospholipids of the cellular membranes and colagen fibres peroxidation. Influences the release, recaptures the neurotransmitters’ catabolism and sensitizes their receptors to its action. It is used in circulatory affections and edemas. Fortifies venas, diminishes the permeability of the vessels. Has antiaggregant effect in the platelike and erythrocitary hyperaggregation and reduces the trombotic microcirculatory risk.
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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Location(s):
Czech Republic, Poland, Romania, and Russian Federation
Year Started:
2003
Year Finished:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Patient having had a single infarct in the carotid artery territory 3 to 8 days before inclusion; patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5); patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time) test in the normal values of the laboratory.
Exclusion Criteria
Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8 days prior; patient with known pre-existent cerebral infarction; infarct damaged area bigger than 1/3 hemisphere; patient having a score below the cut-off point at Frenchay Aphasia Short Test.
Patient Involvement:
Patients are randomized to one of two arms: Experimental arm with Drug: EGb761 (Tanakan) and acetylsalicylic acid
EGb761 (Tanakan) 40mg tablets (2 tablets tid) 240mg/day AND acetylsalicylic acid (1 tablet once daily), 325 mg/day, for 6 months or placebo comparator with Drug: Placebo and acetylsalicylic acid
Placebo 40 mg tablets (2 tablets tid) AND acetylsalicylic acid, 325 mg/day (1 tablet once daily) for 6 months. Patients will have baseline and 6 month evaluation with
Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.
Primary Outcome:
Patients with Modified Rankin score 0 or 1 or 2 at the end of study period.
Secondary Outcome:
Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/19/2009.
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