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

June 11, 2015 updated by: Afshin Borhani-Haghighi, Shiraz University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
patients with acute ischemic stroke who received standard care plus placebo filled capsules,
Drug: Placebo
Experimental: 450 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.
Drug: 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
Experimental: 900 mg licorice
patients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Atfer hospital stay, 5-14 days
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
Time Frame: Atfer hospital stay, 5-14 days
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
Time Frame: 3 months after stroke
3 months after stroke
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months
Time Frame: 3 months after stroke
3 months after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sugar
Time Frame: Participants were followed during their hospital stay for an average duration of 5 days
For measurement of possible hyperglycemic effect
Participants were followed during their hospital stay for an average duration of 5 days
Blood pressure
Time Frame: Participants were followed during their hospital stay for an average duration of 5 days
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
Serum Na and K
Time Frame: Participants were followed during their hospital stay for an average duration of 5 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 30, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-01-01-4806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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