AllerVarx™ Clinical Trial


Clinical Study Design

  • Open label, observational study (Renato Ariano. Acta Biomed 2015; Vol. 86, N. 1: 53-58)

  • Inclusion
    • Male and female (Adult)
    • History of allergic rhinitis (≥ 1 year)
    • Positive skin prick test (RAST) to Parietaria officinialis pollen
    • Baseline nasal and/or ocular symptoms of seasonal rhinitis

  • Dosing: 2 tablets per day. In the morning and evening at or after mealtime

  • Treatment period: 30 day duration

  • Data collection: Baseline and D30

Evaluation Methods

  • Evaluation methods:
    • Relief of signs and symptoms of ARC using the Total Symptoms Score and Scale (TSS):
      • 6 clinical parameters graded from 0-3 based on episodes per day
          0 = absence
          1 = 1-5 episodes
          2 = 6-10 episodes
          3 = ≥11 episodes
  • Reduction of the consumption of anti-allergic drugs (patient recorded at baseline and D30)

  • Safety: Monitoring adverse events (AEs)




AllerVarx™ Efficacy







Efficacy & Safety Summary

  • AllerVarx™ containing quercetin, perilla dry extract and vitamin D3, is effective in reducing nasal and / or ocular symptoms in subjects with seasonal allergic rhinitis
    • TSS: highly significant reduction (p> 0.001) of the overall symptoms, with a reduction of approximately 70%
    • Individual Symptoms: highly significant reduction (p> 0.001) of each symptom
    • Reduction of use of anti-allergic drugs (73%)

  • Well tolerated
    • No side effects recorded
    • All subjects completed the study

Additional Clinical & Scientific Data

AllerVarx™- Mechanism of Action



Perilla (Perilla frutescens)


  • Shown in vivo and in vitro antiallergic activity mediated by inhibition of the release of histamine and expression of interleukins (Il-6, TNF-α).5,6,7,12

  • Preclinical Data
    • Inhibited mast cell-mediated allergic reations (rat)7,8
    • Dose dependently increased plasma levels of histamine (rat)7
    • Inhibited systemic and local allergic reactions7,9

  • Clinical Data
    • Significantly reduce the symptoms and number of neutrophils and eosinophils in nasal fluid of seasonal allergic rhinoconjunctivitis compared to placebo.10
    • Inhibit the release of histamine from mast cells.10
    • Selectively blocks the activity of 5-lipoxygenase and 12-lipoxygenase, a key enzyme in one of the pathways of inflammation. 11




Quercetin


  • Naturally occurring dietary flavonol compound.13,14
  • Used therapeutically in allergic conditions, including asthma and hayfever, eczema, and hives. A natural antihistaminic. 13,14
  • Prevents the recruitment of mast cells (inhibition of cytokines and chemokines: IL-8, ICAM-1). 13,14
  • Acts as an inhibitor of mast cell secretion by decreasing the release of tryptase, MCP-1 and IL-6 and the down-regulation of histidine decarboxylase (HDC) mRNA from some mast cell lines.15

Quercetin stabilizes mast cells preventing degranulation and release of components that cause symptomatic allergic effects14


Vitamin D3


  • Vitamin D contributes to the normal function of the immune system. 16,17
  • Mast cells metabolize Vitamin D3 to dampen IgE-mediated mast cell activation in vitro and in vivo.18

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*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.

Please talk to your doctor before taking AllerVarx™. AllerVarx™ is not a drug- it is a dietary supplement. In a published clinical trial, AllerVarx™ has been used safely with minor side effects. Do not use if you are allergic to any ingredients of AllerVarx™. Pregnant women and women who are nursing should not take supplements including AllerVarx™ without first talking to their doctor. Do not exceed the recommended dose. Take with food.