AzTrials
AzTrials

Acute StrokePhase 1/2NCT02473458

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

A Phase 1/2 study testing Licorice whole extract in people with Acute Stroke, run by Shiraz University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Stroke
What is being tested?
Licorice whole extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteIran
Study dates
Jun 2012to Jun 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms of acute ischemic stroke
  • ROSIER score higher than 2
  • Confirmation of ischemic brain damage in CT scan

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Emergency Departement of Namazi hospital

    Shiraz, Fars

Other trials in Iran

About this study

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.

Conditions
Acute Stroke
Being tested
Licorice whole extract, Placebo
Keywords
Licorice, Glycyrrhizic acid, Ischemic Stroke, Acute
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Licorice whole extractDrug

    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

  • PlaceboDrug

Study groups in NCT02473458
Study groupRoleWhat they receive
ControlPlacebo comparatorpatients with acute ischemic stroke who received standard care plus placebo filled capsules,
Receives: Drug: Placebo
450 mg licoriceExperimentalpatients with acute ischemic stroke who received standard care plus capsules filled with 450 mg of whole extract of licorice.
Receives: Drug: Licorice whole extract
900 mg licoriceExperimentalpatients with acute ischemic stroke who received standard care plus capsules filled with 900 mg of whole extract of licorice.
Receives: Drug: Licorice whole extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Atfer hospital stay, 5-14 days

  2. 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

    Measured: Atfer hospital stay, 5-14 days

  3. Change from baseline of neurological status of the patient measured by National Institute of health stroke Scale (NIHSS) after 3 months

    Measured: 3 months after stroke

  4. Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months

    Measured: 3 months after stroke

Secondary outcomes (3)

  1. Blood sugar

    For measurement of possible hyperglycemic effect

    Measured: Participants were followed during their hospital stay for an average duration of 5 days

  2. Blood pressure

    For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

    Measured: Participants were followed during their hospital stay for an average duration of 5 days

  3. Serum Na and K

    For detection of possible of occurrence hypertension due to pseudo-hyperaldosteronism effect of licorice

    Measured: Participants were followed during their hospital stay for an average duration of 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473458
Sponsor's protocol ID
90-01-01-4806
Status last verified
Jun 2015
First submitted
30 May 2015
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Hinkle JL, Guanci MM. Acute ischemic stroke review. J Neurosci Nurs. 2007 Oct;39(5):285-93, 310. doi: 10.1097/01376517-200710000-00005.

    PubMed 17966295

  • 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.

    PubMed 23239837

  • 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.

    PubMed 18192863

  • 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.

    PubMed 21164112

  • 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.

    PubMed 16867245

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Licorice whole extract in people with Acute Stroke, run by Shiraz University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473458, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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