Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of acute ischemic stroke
- •ROSIER score higher than 2
- •Confirmation of ischemic brain damage in CT scan
排除标准
- •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
研究组 & 干预措施
Control
patients with acute ischemic stroke who received standard care plus placebo filled capsules,
干预措施: Placebo (Drug)
450 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.
干预措施: Licorice whole extract (Drug)
900 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.
干预措施: Licorice whole extract (Drug)
结局指标
主要结局
Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after hospital stay
时间窗: Atfer hospital stay, 5-14 days
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
时间窗: Atfer hospital stay, 5-14 days
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
时间窗: 3 months after stroke
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months
时间窗: 3 months after stroke
次要结局
- 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)
研究者
Afshin Borhani-Haghighi
Associate professor of Neurology
Shiraz University of Medical Sciences