Radicle Science has shared news of how its Radicle Proof Engine Proof-as-a-Service offering is assisting non-pharmaceuticals to generate clinical evidence to close the proof gap between non-prescription wellness products and pharmaceutical drugs. The company says its AI-driven crowdsourced, virtual, direct-to-consumer (D2C) clinical trial approach delivers objective health outcome data across diverse conditions and populations. The approach is designed to enable supplement brands to develop innovative products, market defensible claims, and more.
Showcasing one example, Radicle Science shared how the approach empowered Floraworks to conduct a study validating the efficacy of its flagship product, TruCBN, as an innovative sleep aid solution. Leveraging Radicle's Proof-as-a-Service approach, Floraworks substantiated the product’s effectiveness through a clinical trial and set new standards in the sleep aid market.
As Radicle explains, the clinical trial utilized a randomized, double-blind, placebo-controlled design. It encompassed five distinct arms to assess the efficacy of TruCBN. Three arms featured escalating doses of the product, the fourth arm represented a placebo, and fifth served as a comparative measure by including melatonin. Radicle Science collaborated with researchers at UCLA and the University of Maryland School of Medicine to design and execute the trial, which yielded conclusive results in under three months.
The findings: Researchers noted a significant effect on sleep compared to the placebo, as well as a significant difference between the 4 mg melatonin softgel and the placebo. There were no significant differences in the frequency of reported side effects between any dose of TruCBN compared to placebo, which Radicle noted suggests a favorable safety profile.
Radicle added that FloraWorks has enhanced its competitive edge in the cannabinoid-based sleep solutions market by leveraging the scientific findings in marketing and sales collateral.
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