Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-03-07 @ 9:19 PM
Study NCT ID:
NCT02473458
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2015-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2015-05-30', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay', 'timeFrame': 'Atfer hospital stay, 5-14 days', 'description': 'This scale is a standard measurement of neurological status of the patient'}, {'measure': 'Change from baseline of neurological status of the patient measured by Modified Rankin Scale after hospital stay', 'timeFrame': 'Atfer hospital stay, 5-14 days', 'description': 'This scale is a standard measurement of neurological status of the patient'}, {'measure': 'Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after 3 months', 'timeFrame': '3 months after stroke'}, {'measure': 'Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months', 'timeFrame': '3 months after stroke'}], 'secondaryOutcomes': [{'measure': 'Blood sugar', 'timeFrame': 'Participants were followed during their hospital stay for an average duration of 5 days', 'description': 'For measurement of possible hyperglycemic effect'}, {'measure': 'Blood pressure', 'timeFrame': 'Participants were followed during their hospital stay for an average duration of 5 days', 'description': 'For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice'}, {'measure': 'Serum Na and K', 'timeFrame': 'Participants were followed during their hospital stay for an average duration of 5 days', 'description': 'For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Licorice', 'Glycyrrhizic acid', 'Ischemic Stroke', 'Acute'], 'conditions': ['Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '17966295', 'type': 'BACKGROUND', '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.'}, {'pmid': '23239837', 'type': 'BACKGROUND', '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.'}, {'pmid': '18192863', 'type': 'BACKGROUND', '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.'}, {'pmid': '21164112', 'type': 'BACKGROUND', '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.'}, {'pmid': '16867245', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nLicorice, 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of acute ischemic stroke\n* ROSIER score higher than 2\n* Confirmation of ischemic brain damage in CT scan\n\nExclusion Criteria:\n\n* Clinically relevant preexisting neurological deficit or previous CVA\n* Primary intracerebral hemorrhage\n* Coma (level of consciousness more than 2 in NIHSS scale).\n* Negative swallow test\n* Patients undergoing hemicraniectomy\n* History of epilepsy\n* Clinical seizure at onset of stroke\n* 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)\n* Atrial fibrillation or other tachy/bradyarrythmias at time of allocation or in the middle of intervention\n* Ejection Fraction less than 45%\n* Potassium less than 4 mEq/dl at onset of stroke\n* Malignancy or premalignant state within 5 years\n* Myocardial infarction in previous month\n* Significant kidney disease (creatinine higher than 1.8 mg/dl)\n* Significant liver disease (Bilirubin \\> 20 mmoll/L)\n* Significant lung disease (FEV1 \\< 1.5 L, pO2 \\< 70 in room air, pCO2 \\> 45)\n* Psychiatric illness requiring hospital admission\n* Warfarin intake\n* Digoxin intake\n* Pregnancy\n* Breast feeding\n* Inability to have follow/up'}, 'identificationModule': {'nctId': 'NCT02473458', 'briefTitle': 'Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '90-01-01-4806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'patients with acute ischemic stroke who received standard care plus placebo filled capsules,', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '450 mg licorice', 'description': 'patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.', 'interventionNames': ['Drug: Licorice whole extract']}, {'type': 'EXPERIMENTAL', 'label': '900 mg licorice', 'description': 'patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.', 'interventionNames': ['Drug: Licorice whole extract']}], 'interventions': [{'name': 'Licorice whole extract', 'type': 'DRUG', 'description': 'Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:\n\n1. Starch-filled capsules (as placebo)\n2. 450 mg whole licorice extract capsules\n3. 900 mg whole licorice extract capsules', 'armGroupLabels': ['450 mg licorice', '900 mg licorice']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Emergency Departement of Namazi hospital', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Neurology', 'investigatorFullName': 'Afshin Borhani-Haghighi', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}