Curtin University Homepage
  • Library
  • Help
    • Admin

    espace - Curtin’s institutional repository

    JavaScript is disabled for your browser. Some features of this site may not work without it.
    View Item 
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item

    L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial).

    Access Status
    Open access
    Authors
    Chaliha, Devahuti
    Vaccarezza, Mauro
    Corti, Emily
    Takechi, Ryusuke
    Dhaliwal, Satvinder
    Drummond, Peter
    Visser, Eric
    Chen, Fred
    Charng, Jason
    Lam, Virginie
    Mamo, John
    Date
    2023
    Type
    Journal Article
    
    Metadata
    Show full item record
    Citation
    Chaliha, D. and Vaccarezza, M. and Corti, E. and Takechi, R. and Dhaliwal, S. and Drummond, P. and Visser, E. et al. 2023. L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial). BMC Neurology. 23: pp. 1-13.
    Source Title
    BMC Neurology
    DOI
    10.1186/s12883-023-03149-y
    ISSN
    1471-2377
    Faculty
    Faculty of Health Sciences
    School
    Curtin Medical School
    Funding and Sponsorship
    Multiple Sclerosis, Western Australia (MSWA)
    MSWA
    URI
    http://hdl.handle.net/20.500.11937/91201
    Collection
    • Curtin Research Publications
    Abstract

    Background

    Migraine is a common and distressing neurological condition characterised by recurrent throbbing headaches, nausea and heightened sensitivity to light and sound. Accumulating evidence suggests that cerebral arteries dilate during migraine, causing distal microvessels to constrict, which could activate nociceptors and cause onset of headache pain. If so, preventing or attenuating chronic microvascular constriction, and promoting a dilatory phenotype, may reduce frequency and/or severity of migraines. The primary aim of the L-Arginine and Aged Garlic Extract (LARGE) trial is to investigate whether oral treatment with dietary nutraceuticals, L-arginine and aged garlic extract (AGE), both systemic vasodilatory agents, will alleviate migraine frequency, duration and severity in adults with chronic frequent episodic migraines. Methods

    The study is a randomised double-blind placebo-controlled phase-II single-site clinical trial conducted in Perth, Australia. The target sample is to recruit 240 participants diagnosed with chronic frequent episodic migraines between 18 and 80 years of age. Participants will be randomised to one of four treatment groups for 14 weeks (placebo induction for 2 weeks, followed by 12 weeks on one of the respective treatment arms): placebo, L-arginine, AGE, or a combination of L-arginine and AGE. The doses of L-arginine and AGE are 1.5 g and 1 g daily, respectively. The primary outcome is to assess migraine response using change in migraine frequency and intensity between baseline and 12 weeks. Secondary outcomes include the impact of L-arginine and/or AGE on photosensitivity, retinal vessel changes, and blood biomarker concentrations of vascular tone, following a 12-week intervention. Discussion

    The protocol describes the oral administration of 2 nutraceutical-based interventions as possible prophylactic treatments for chronic frequent episodic migraines, with potential for direct clinical translation of outcomes. Potential limitations of the study include the fixed-dose design of each treatment arm and that in vivo neuroimaging methods, such as magnetic resonance imaging (MRI), will not be conducted to determine putative cerebro-vasodilatory changes to coincide with the outcome measures. Dose-response studies may be indicated. Trial registration

    The trial was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12621001476820 (Universal Trial Number: U1111-1268-1117) on 04/08/2021. This is protocol version 1, submitted on 25/11/2022.

    Related items

    Showing items related by title, author, creator and subject.

    • Investigating the Efficacy of L-Arginine and Aged Garlic Extract in a Randomised Place-Controlled Clinical Trial: A Vasodilatory Nutraceutical Strategy for Migraine Prevention
      Chaliha, Devahuti Rai (2024)
      While studies imply it is cerebral vasodilation that triggers migraine pain onset, we suggest the carbon-dioxide-inducing vasodilation rescues migraine phenotype by restoring central capillary perfusion instead. We conducted ...
    • Attenuation of chronic tension headache frequency and severity with daily l-arginine and aged garlic extract dietary supplementation
      Chaliha, Devahuti; Vaccarezza, Mauro ; Lam, Virginie ; Takechi, Ryu ; Mamo, John (2021)
      A 74-year-old female subject with suboptimal management of episodic tension headache was treated with a daily dose of 1.5 g l-arginine and 1.2 g aged garlic extract (AGE). The aim of the intervention was to promote ...
    • The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee
      Fary, Robyn (2010)
      Osteoarthritis of the knee is a chronic disease leading to considerable burden on health. Pain, while not always present is the most prominent clinical feature and the cause of significant disability. There are a wide ...
    Advanced search

    Browse

    Communities & CollectionsIssue DateAuthorTitleSubjectDocument TypeThis CollectionIssue DateAuthorTitleSubjectDocument Type

    My Account

    Admin

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Follow Curtin

    • 
    • 
    • 
    • 
    • 

    CRICOS Provider Code: 00301JABN: 99 143 842 569TEQSA: PRV12158

    Copyright | Disclaimer | Privacy statement | Accessibility

    Curtin would like to pay respect to the Aboriginal and Torres Strait Islander members of our community by acknowledging the traditional owners of the land on which the Perth campus is located, the Whadjuk people of the Nyungar Nation; and on our Kalgoorlie campus, the Wongutha people of the North-Eastern Goldfields.