A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke

Completed

Phase 3 Results N/A

Trial Description

The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.

Conditions

Interventions

  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Placebo Drug
    Intervention Desc: 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.
  • EGb761 (Tanakan)Drug
    Intervention Desc: 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.
  • EGb761 (Tanakan) and acetylsalicylic acid Drug
    Intervention Desc: EGb761 (Tanakan) 40mg tablets (2 tablets tid) 240mg/day AND acetylsalicylic acid (1 tablet once daily), 325 mg/day, for 6 months
    ARM 1: Kind: Experimental
    Label: 1
  • Placebo and acetylsalicylic acid Drug
    Intervention Desc: Placebo 40 mg tablets (2 tablets tid) AND acetylsalicylic acid, 325 mg/day (1 tablet once daily) for 6 months
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

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 withBarthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.

Outcomes

Type Measure Time Frame Safety Issue
Primary Patients with Modified Rankin score 0 or 1 or 2 at the end of study period.
Secondary Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State.
Secondary Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State 6 months No

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