Allergic Rhinitis Clinical Trial
Official title:
SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.
Sinol is an FDA registered, capsaicin-based, over-the-counter homeopathic nasal spray used
for the relief of allergy and sinus conditions. It is an all-natural product that the patient
uses on an as-needed basis for up to 12 times daily.
Sinol has been available in the US since 2004. In 2009 a second generation product, Sinol-M
will be launched. Sinol-M is identical to the original formula but also contains MucoAd
MucoAd™ is a patented non-toxic, non-irritating, liquid polymer mucoadhesive carrier that
prolongs the contact time between drug and mucosa, thus increasing bioavailability. It can be
loaded with nearly any pharmaceutical preparation and delivered a variety of mucosal tissues.
Reduced mucociliary clearance of intranasally-applied drugs is desirable to reduce the
naturally-occurring washing out of topically applied medications.
The objective of the current Phase IV, randomized, double-blind, cross-over study, was to
evaluate the frequency of use and efficacy of SINOL and SINOL + MucoAd™ (Sinol-M) and to
demonstrate non-inferiority of Sinol-M versus the existing product Sinol.
Additionally, as most homeopathic drugs are not supported by prospective clinical data there
is a belief among many mainstream healthcare practitioners, and some consumers that these
products do not work. This study therefore provides an opportunity to demonstrate improved
efficacy versus no treatment (during the run-in and washout phases).
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