Stroke is one of the most important causes of mortality and disability both in developed and developing countries. The only food and drug administration (FDA) approved therapy for acute stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be mandatory in the world of cerebrovascular medicine. Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used in food industries. Certain medical properties has been contributed to licorice and specifically to its active chemical components such as flavonoids and glycyrrhizic acid (GA). GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a key component of lipopolysaccharide-induced inflammatory response. Neuroprotective characteristics of GA has been widely investigated in recent studies. In the present study, the investigators verified the efficacy and safety of oral administration of two different doses licorice extract in the patients with acute ischemic stroke, in a double-blind randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack: 1. Starch-filled capsules (as placebo) 2. 450 mg whole licorice extract capsules 3. 900 mg whole licorice extract capsules
Emergency Departement of Namazi hospital
Shiraz, Fars, Iran
Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay
This scale is a standard measurement of neurological status of the patient
Time frame: Atfer hospital stay, 5-14 days
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after hospital stay
This scale is a standard measurement of neurological status of the patient
Time frame: Atfer hospital stay, 5-14 days
Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after 3 months
Time frame: 3 months after stroke
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months
Time frame: 3 months after stroke
Blood sugar
For measurement of possible hyperglycemic effect
Time frame: Participants were followed during their hospital stay for an average duration of 5 days
Blood pressure
For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice
Time frame: Participants were followed during their hospital stay for an average duration of 5 days
Serum Na and K
For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice
Time frame: Participants were followed during their hospital stay for an average duration of 5 days
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