ABSTRACT
Allergy prevalence has increased over the past few decades,1 and there is accumulating evidence that botanicals may be useful for the associated symptoms.2-4 In order to commercialize a botanical dietary supplement to support clear nasal passages, we used an approach combining biological and clinical techniques. Botanical
CONTENTS
Introduction ............................................................................................................ 173 In Vitro Screening of Botanicals ........................................................................... 174
Identification of Botanicals ............................................................................... 174 Materials and Methods...................................................................................... 174
Mediator Release Assays ......................................................................... 174 Results ............................................................................................................... 174 Discussion ......................................................................................................... 175
Skin Patch Dose-Response Study ......................................................................... 176 Materials and Methods...................................................................................... 176 Results ............................................................................................................... 178 Discussion ......................................................................................................... 179
Nasal Allergen Challenge Clinical Study .............................................................. 180 Material and Methods ....................................................................................... 180 Results ............................................................................................................... 181
Early-Phase Response .............................................................................. 181 Late-Phase Response ............................................................................... 182
Safety................................................................................................................. 184 Discussion .............................................................................................................. 184 References .............................................................................................................. 186
compounds with possible anti-allergic action that also met cost, availability, and global regulatory hurdles were screened in bioassays for anti-allergic action, singly and in various combinations. A selection of these was then submitted to skin-patch testing with human volunteers. Results from skin patch testing were used to formulate a potentially effective botanical combination formula based on a benchmark of wheal-size reduction associated with a standard anti-allergy pharmaceutical. This botanical formula was then tested in a double-blind, placebo-controlled clinical study using the nasal allergen challenge model of anti-allergic action. This sequence of actions can be seen as a model for achieving market entry and general market competitiveness of innovative technologies and products in the dietary supplement field.
