Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke

Completed

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Control
    Description: patients with acute ischemic stroke who received standard care plus placebo filled capsules,
  • Licorice whole extract Drug
    Intervention Desc: Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack: Starch-filled capsules (as placebo) 450 mg whole licorice extract capsules 900 mg whole licorice extract capsules
    ARM 1: Kind: Experimental
    Label: 450 mg licorice
    Description: patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.
    ARM 2: Kind: Experimental
    Label: 900 mg licorice
    Description: patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay Atfer hospital stay, 5-14 days No
Primary Change from baseline of neurological status of the patient measured by Modified Rankin Scale after hospital stay Atfer hospital stay, 5-14 days No
Primary Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after 3 months 3 months after stroke No
Primary Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months 3 months after stroke No
Secondary Blood sugar Participants were followed during their hospital stay for an average duration of 5 days Yes
Secondary Blood pressure Participants were followed during their hospital stay for an average duration of 5 days Yes
Secondary Serum Na and K Participants were followed during their hospital stay for an average duration of 5 days Yes

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