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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | patients with acute ischemic stroke who received standard care plus placebo filled capsules, |
|
| 450 mg licorice | Experimental | patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice. |
|
| 900 mg licorice | Experimental | patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licorice whole extract | Drug | Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sugar | For measurement of possible hyperglycemic effect | Participants were followed during their hospital stay for an average duration of 5 days |
| Blood pressure | For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Departement of Namazi hospital | Shiraz | Fars | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17966295 | Background | Hinkle JL, Guanci MM. Acute ischemic stroke review. J Neurosci Nurs. 2007 Oct;39(5):285-93, 310. doi: 10.1097/01376517-200710000-00005. | |
| 23239837 | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Drug |
|
| Participants were followed during their hospital stay for an average duration of 5 days |
| 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 |
| 18192863 | 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. |
| 21164112 | 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. |
| 16867245 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |