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

Acute Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473458
• Other study ID #: 90-01-01-4806
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 30, 2015
• Last updated: June 11, 2015
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Stroke

Intervention

Drug:
• Licorice whole extract
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Emergency Departement of Namazi hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

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. — View Citation

Granitto M, Galitz D. Update on stroke: the latest guidelines. Nurse Pract. 2008 Jan;33(1):39-46; quiz 47. doi: 10.1097/01.NPR.0000305977.24952.1c. — View Citation

Hinkle JL, Guanci MM. Acute ischemic stroke review. J Neurosci Nurs. 2007 Oct;39(5):285-93, 310. Review. — View Citation

Hwang IK, Lim SS, Choi KH, Yoo KY, Shin HK, Kim EJ, Yoon-Park JH, Kang TC, Kim YS, Kwon DY, Kim DW, Moon WK, Won MH. Neuroprotective effects of roasted licorice, not raw form, on neuronal injury in gerbil hippocampus after transient forebrain ischemia. Acta Pharmacol Sin. 2006 Aug;27(8):959-65. — View Citation

Ramos-Cabrer P, Campos F, Sobrino T, Castillo J. Targeting the ischemic penumbra. Stroke. 2011 Jan;42(1 Suppl):S7-11. doi: 10.1161/STROKEAHA.110.596684. Epub 2010 Dec 16. — View Citation

Outcome

Type	Measure	Description	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	This scale is a standard measurement of neurological status of the patient	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	This scale is a standard measurement of neurological status of the patient	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	For measurement of possible hyperglycemic effect	Participants were followed during their hospital stay for an average duration of 5 days	Yes
Secondary	Blood pressure	For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice	Participants were followed during their hospital stay for an average duration of 5 days	Yes
Secondary	Serum Na and K	For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice	Participants were followed during their hospital stay for an average duration of 5 days	Yes