Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke
- Registration Number
- NCT02473458
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Symptoms of acute ischemic stroke
- ROSIER score higher than 2
- Confirmation of ischemic brain damage in CT scan
- Clinically relevant preexisting neurological deficit or previous CVA
- Primary intracerebral hemorrhage
- Coma (level of consciousness more than 2 in NIHSS scale).
- Negative swallow test
- Patients undergoing hemicraniectomy
- History of epilepsy
- Clinical seizure at onset of stroke
- Systolic BP is >160 mmHg, diastolic BP>110 at onset of stroke (if a rise in blood pressure occurred in the course of study it was controlled according to medical guidelines)
- Atrial fibrillation or other tachy/bradyarrythmias at time of allocation or in the middle of intervention
- Ejection Fraction less than 45%
- Potassium less than 4 mEq/dl at onset of stroke
- Malignancy or premalignant state within 5 years
- Myocardial infarction in previous month
- Significant kidney disease (creatinine higher than 1.8 mg/dl)
- Significant liver disease (Bilirubin > 20 mmoll/L)
- Significant lung disease (FEV1 < 1.5 L, pO2 < 70 in room air, pCO2 > 45)
- Psychiatric illness requiring hospital admission
- Warfarin intake
- Digoxin intake
- Pregnancy
- Breast feeding
- Inability to have follow/up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo patients with acute ischemic stroke who received standard care plus placebo filled capsules, 450 mg licorice Licorice whole extract patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice. 900 mg licorice Licorice whole extract patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.
- Primary Outcome Measures
Name Time Method 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 This scale is a standard measurement of neurological status of the patient
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after hospital stay Atfer hospital stay, 5-14 days This scale is a standard measurement of neurological status of the patient
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 Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months 3 months after stroke
- Secondary Outcome Measures
Name Time Method Blood sugar Participants were followed during their hospital stay for an average duration of 5 days For measurement of possible hyperglycemic effect
Blood pressure Participants were followed during their hospital stay for an average duration of 5 days For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice
Serum Na and K Participants were followed during their hospital stay for an average duration of 5 days For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice
Trial Locations
- Locations (1)
Emergency Departement of Namazi hospital
🇮🇷Shiraz, Fars, Iran, Islamic Republic of