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

Primary Purpose

Acute Stroke

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Licorice whole extract

Placebo

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Licorice, Glycyrrhizic acid, Ischemic Stroke, Acute

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emergency Departement of Namazi hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

450 mg licorice

900 mg licorice

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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

Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after 3 months

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

Secondary Outcome Measures

Blood sugar

For measurement of possible hyperglycemic effect

Blood pressure

For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

Serum Na and K

For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

Full Information

NCT ID

NCT02473458

First Posted

May 30, 2015

Last Updated

June 11, 2015

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02473458

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke

Keywords

Licorice, Glycyrrhizic acid, Ischemic Stroke, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

450 mg licorice

Arm Type

Experimental

Arm Description

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

Arm Title

900 mg licorice

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Licorice whole extract

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Atfer hospital stay, 5-14 days

Title

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

Description

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

Time Frame

Atfer hospital stay, 5-14 days

Title

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

Title

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 Measure Information:

Title

Blood sugar

Description

For measurement of possible hyperglycemic effect

Time Frame

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

Title

Blood pressure

Description

For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

Time Frame

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

Title

Serum Na and K

Description

For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Emergency Departement of Namazi hospital

City

Shiraz

State/Province

Fars

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

17966295

Citation

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

Results Reference

background

PubMed Identifier

23239837

Citation

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. Erratum In: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.

Results Reference

background

PubMed Identifier

18192863

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. No abstract available.

Results Reference

background

PubMed Identifier

21164112

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.

Results Reference

background

PubMed Identifier

16867245

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

Results Reference

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

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