CLINICAL EVALUATION OF SAFETY AND EFFICACY OF DE-STRESS AND SLEEP GUMMIES
Dr. Kriti Soni*, Dr. Sachin Mulik and Dr. Gayatri Ganu
ABSTRACT
Introduction: Chronic insomnia affects 5-10% of adults in developed countries, often associated with stress and
mental health challenges. Traditional pharmacological interventions frequently present side effects, motivating
research into alternative stress and sleep management strategies. This clinical trial investigated the safety and
efficacy of a novel phytoconstituent-based gummy supplement in reducing stress and improving sleep quality.
Materials and Methods: An open-label, single-arm clinical study was conducted with 30 healthy volunteers (15
males, 15 females). The investigational product contained extracts of Withania somnifera, L-Theanine, Matricaria
chamomilla, and Crocus sativus. Participants consumed two destress and snooze gummies daily, 30 minutes
before bed for 30 days. Participants were evaluated using the Perceived Stress Scale (PSS) and Insomnia Severity
Index (ISI). Comprehensive hematological, biochemical, and vital sign assessments were performed at screening
and after 30 days of intervention. Results: The study demonstrated statistically significant improvements: 47.84%
reduction in perceived stress and 38.38% decrease in insomnia severity. Most blood parameters remained stable,
with a notable decrease in creatinine levels. Only 4 participants (13.33%) experienced mild adverse events
unrelated to the investigational product. Conclusion: The phytoconstituent-based gummies proved safe and
effective in managing stress and improving sleep quality. The formulation's safety, tolerability, and potential
efficacy make it an intriguing option for further investigation and potential integration into holistic stress and sleep
management strategies
Keywords: Stress Management, Insomnia, Herbal Supplements, Withania somnifera, L-Theanine.
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