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

NCT02473458 | Completed Phase 1 DMC

• 1 other identifier: 90-01-01-4806
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

Licorice; Glycyrrhizic acid; Ischemic Stroke; Acute

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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 Outcomes (3)

• Blood sugar

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

• Blood pressure

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

• Serum Na and K

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

Study Arms (3)

Control

PLACEBO COMPARATOR

patients with acute ischemic stroke who received standard care plus placebo filled capsules,

Drug: Placebo

450 mg licorice

EXPERIMENTAL

patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.

Drug: Licorice whole extract

900 mg licorice

EXPERIMENTAL

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

Drug: Licorice whole extract

Interventions

Licorice whole extract DRUG

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

450 mg licorice; 900 mg licorice

Placebo DRUG

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Emergency Departement of Namazi hospital

Shiraz, Fars, Iran

Location

Related Publications (5)

• Hinkle JL, Guanci MM. Acute ischemic stroke review. J Neurosci Nurs. 2007 Oct;39(5):285-93, 310. doi: 10.1097/01376517-200710000-00005.

  PMID: 17966295 BACKGROUND

• 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. No abstract available.

  PMID: 23239837 BACKGROUND

• 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. No abstract available.

  PMID: 18192863 BACKGROUND

• 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.

  PMID: 21164112 BACKGROUND

• 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. doi: 10.1111/j.1745-7254.2006.00346.x.

  PMID: 16867245 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Study Record Dates

• First Submitted: May 30, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

IR (1)