An Approach To A Clinical Trial Involving Natural Health Products | 13335
Clinical Pharmacology & Biopharmaceutics
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Clinical efficacy of Natural Health Products (NHPs) of plant origin is often limited and variable. This is likely due to extracts used
not being standardized. The roots, flowers, stems, leaves, and seeds of a plant could be used in a pruduct either in isolation or
collectively, and called an ?extract?. The chemical constutuents, however, can differ quantitavely and qualitatively between different
parts and some times different species of a plant. There also exists multiple biologically active components in a plant that work
synnergistically. It is essential that these components are present in a product in their optimal amounts and proportions for the best
effective clinical outcome. Because of these complexities, a clinical study design for a natural health product, meeting all criteria,
becomes a challenge as opposed to a study design for a drug, which normally involves a single active component. Using Echinacea
plant (a popular herbal plant, indigenous to North America) as example, this presentation will provide a critical evaluation of the
validity of its clinical efficacy claims, and describe an approach to a randomized, double-blind placebo-controlled clinical trial,
which was designed taking into account the complexicities that are involved in NHPs.
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