Portland, Oregon--(Newsfile Corp. - September 18, 2023) - FloraWorks Holdings Inc., a leading cannabinoid therapeutics company, announced that its flagship product TruCBN™ (a pure form of cannabinol or "CBN") demonstrated effectiveness in treating sleep disturbances in a recent landmark clinical trial independently conducted by Radicle Science. In the industry-first, double-blind, randomized, placebo-controlled trial, 25, 50, and 100 milligrams of TruCBN™ were found to significantly enhance sleep outcomes and provide clinically meaningful improvement.
This groundbreaking trial is the first to compare the effects of CBN against a placebo, and one of the largest controlled clinical studies in history to evaluate a cannabinoid, with more than 1,000 diverse volunteers across the United States participating in the research. Participants received one of five different products: three different doses of TruCBN™, melatonin, or a placebo.
Key findings from the study include:
- The groups taking 25, 50, or 100 mg of TruCBN™ all showed a significant improvement in sleep compared to placebo.
- The group taking 4 mg melatonin also showed a significant improvement in sleep compared to placebo.
- 53.6% of participants receiving the 50 mg of TruCBN™ had a clinically meaningful improvement in their sleep - the greatest percentage out of any groups, including the melatonin group.
- The improvement seen in the melatonin group was not significantly different from the improvement seen in any of the three TruCBN™ groups.
- All side effects were mild to moderate. There were no significant differences in the frequency of reported side effects between any dose of TruCBN™ or melatonin compared to placebo.
"Our results pave the way for developing more safe, effective sleep solutions, ultimately improving the quality of life for millions of people who struggle with sleep disturbances," said Alleh Lindquist, CEO and Co-Founder of FloraWorks. "These findings bring needed clarity to the rapidly growing consumer demand for existing CBN products. Our TruCBN™ will be a strong, new competitor in the global sleep aid market, marking a major milestone in building consumer trust and confidence in the therapeutic potential of cannabinoids."
Dr. Jeff Chen, MD/MBA, Co-Founder and CEO of Radicle Science, said, "The historical firsts encompassed in this study have tremendous implications for formulating effective, natural sleep products for Americans. The findings especially highlight the importance of understanding the appropriate dosage for the desired health outcome. For CBN, higher concentrations like 100 mg do not seem to improve effectiveness for sleep disturbance compared to lower concentrations like 50 mg. This is some of the first human data to suggest CBN can significantly improve sleep, and the effects may be comparable to the most studied and used dietary supplement sleep ingredient: melatonin. It highlights the importance of exploring product formulations in a methodical, clinical manner through randomized, blinded clinical trials."
Dr. Susan Hewlings, Ph.D., RD, Vice President of Research Affairs at Radicle Science, explained, "It's very promising to discover that CBN could be just as effective - and possibly better - than melatonin. Many cannot tolerate melatonin's side effects and it is regulated as a prescription drug in countries like the UK and Japan. This discussion is especially timely given the recent FDA scrutiny towards melatonin dosage and concerns about consuming melatonin above recommended doses."
Clinical findings like these from FloraWorks and Radicle Science have the potential to become major market disruptors to the legacy over-the-counter sleep aid market. Almost fifty percent of Americans experience sleep deprivation, according to the latest CDC survey, and poor sleep has become a public health concern, as it is linked to many health issues, including inflammatory conditions, obesity, heart disease, and overall reduced quality of life. As consumers increasingly seek natural and safe alternatives for better sleep, the introduction of a non-intoxicating, hemp-derived cannabinoid solution presents an attractive option. This could lead to a decline in demand for traditional sleep aids, as the results of this study build consumer trust and confidence in TruCBN™ as a safe, effective, and natural alternative.
FloraWorks is a leading cannabinoid therapeutic development company specializing in high-quality, innovative products designed to improve health and wellness. With a focus on safety, efficacy, and consumer trust, FloraWorks is dedicated to unlocking the therapeutic potential of rare and novel cannabinoids, creating effective solutions that cater to a wide range of needs. For more information, visit www.flora-works.com.
About Radicle Science:
Radicle Science is history's first Proof-as-a-Service company, enabling non-prescription health and wellness products to clinically prove their true effects beyond placebo. The B-corp offers non-pharmaceutical products the first easy path to generate first-of-its-kind clinical evidence across diverse conditions and populations at unprecedented affordability, speed, and scale. Radicle's transformative approach democratizes access to clinical trials and can finally close the "proof gap" between non-prescription wellness products and pharmaceutical drugs.
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