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

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ClinicalTrials.gov Identifier: NCT02473458
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Afshin Borhani-Haghighi, 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.


Condition or disease Intervention/treatment Phase
Acute Stroke Drug: Licorice whole extract Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
patients with acute ischemic stroke who received standard care plus placebo filled capsules,
Drug: Placebo
Experimental: 450 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.
Drug: Licorice whole extract

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

Experimental: 900 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.
Drug: Licorice whole extract

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473458


Locations
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Iran, Islamic Republic of
Emergency Departement of Namazi hospital
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences

Publications:
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.

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Responsible Party: Afshin Borhani-Haghighi, Associate professor of Neurology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02473458     History of Changes
Other Study ID Numbers: 90-01-01-4806
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Afshin Borhani-Haghighi, Shiraz University of Medical Sciences:
Licorice
Glycyrrhizic acid
Ischemic Stroke
Acute
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases