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NCT02473458
Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke
Phase 1/Phase 2 trial testing Licorice whole extract in Acute Stroke in 75 participants. Completed in 1 June 2014.
1 June 2013
Quick facts
| Lead sponsor | Shiraz University of Medical Sciences |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 June 2012 |
| Primary completion | 1 June 2013 |
| Estimated completion | 1 June 2014 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Licorice whole extract — full drug profile →
- Placebo
Conditions studied
- Acute Stroke — all drugs for Acute Stroke →
Sponsor
Shiraz University of Medical Sciences
Who can join
Adults 18 to 85, any sex, with Acute Stroke. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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 -
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 -
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 -
Change from baseline of neurological status of the patient measured by Modified Rankin Scale after 3 months
Time frame: 3 months after stroke
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02473458
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shiraz University of Medical Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02473458 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shiraz University of Medical Sciences
- Last refreshed: 11 June 2015
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