Acute Stroke Clinical Trial
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Emergency Departement of Namazi hospital | Shiraz | Fars |
Lead Sponsor | Collaborator |
---|---|
Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
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
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 |
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