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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombolysis Outcome in Ischemic Stroke

NCT04309357

Stroke, Acute Thrombolytic Therapy Alteplase +1 more

COMPLETED

Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke

NCT07003386

Acute Ischemic Stroke AIS

RECRUITING PHASE2/PHASE3

Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients

NCT05086874

Stroke Cerebral Infarction Brain Infarction +5 more

COMPLETED

Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

NCT00840671

Stroke

COMPLETED PHASE3

Pre-stroke Cognitive Status and Thrombolytic Therapy

NCT01713491

Brain Ischemia Adverse Effect of Thrombolytic Drugs Impaired Cognition +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

450 mg licorice

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

Group Type EXPERIMENTAL

Licorice whole extract

Intervention Type DRUG

Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:

1. Starch-filled capsules (as placebo)
2. 450 mg whole licorice extract capsules
3. 900 mg whole licorice extract capsules

900 mg licorice

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

Group Type EXPERIMENTAL

Licorice whole extract

Intervention Type DRUG

Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:

1. Starch-filled capsules (as placebo)
2. 450 mg whole licorice extract capsules
3. 900 mg whole licorice extract capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Licorice whole extract

Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:

1. Starch-filled capsules (as placebo)
2. 450 mg whole licorice extract capsules
3. 900 mg whole licorice extract capsules

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No