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Completed

NCT Number: NCT02473458

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

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Emergency Departement of Namazi hospital

Shiraz, Fars, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptoms of acute ischemic stroke
  • ROSIER score higher than 2
  • Confirmation of ischemic brain damage in CT scan

Exclusion criteria

  • 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

Treatment and study plan

Licorice whole extract

Drug

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

Placebo

Drug

Primary outcomes

  1. Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay

    Time frame: Atfer hospital stay, 5-14 days

    This scale is a standard measurement of neurological status of the patient

  2. Change from baseline of neurological status of the patient measured by Modified Rankin Scale after hospital stay

    Time frame: Atfer hospital stay, 5-14 days

    This scale is a standard measurement of neurological status of the patient

  3. 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

  4. Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months

    Time frame: 3 months after stroke

Secondary outcomes

  1. Blood sugar

    Time frame: Participants were followed during their hospital stay for an average duration of 5 days

    For measurement of possible hyperglycemic effect

  2. Blood pressure

    Time frame: 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

  3. Serum Na and K

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 16, 2015
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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