Congratulations to Asystem for completing their clinical trial with Citruslabs
Asystems' Complete Calm Supplement is Effective at Promoting and Supporting Sleep
Studying the Asystem Calm Supplement
ASYSTEMS developed a line of supplementation to specifically address challenges with sleep in the modern world. The Complete Calm supplement consists of the "De-stress Gummies" and "Sleep Gummies". Both products contain a blend of adaptogens, terpenes, and Safr'Inside. The overall goal of these supplements is that users experience improved sleep quality and duration, as well as reduce their stress and anxiety. The key ingredient in both supplements are Safr'Inside which combines adaptogens, lion's mane, Rhodiola, lemon balm, and terpene blends. The de-stress gummies also have Panax ginseng. The Sleep Gummies also have l-tryptophan, melatonin, chamomile extract, passionflower extract, and holy basil. These ingredients have previously been shown to be effective in helping reduce stress and aid in sleep.
This trial is an exploratory look at the Complete Calm supplement with the main goal of understanding how Complete Calm supports healthy sleep habits, reduces stress and anxiety, as well as lifting mood.
The dietary supplement (Complete Calm supplement) tested in this trial includes:
This was an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.
A total of 33 men and women were recruited for this trial. Each of the participants was screened and deemed eligible to participate based on inclusion and exclusion criteria. The trial was run virtually using a technology platform. The participants in the trial took the Complete Calm Product, consisting of both the De-Stress Gummies (during the day) and the Sleep Gummies (at night) for four weeks. 28 participants finished the entire study and completed the questionnaires at all measurement points.
Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
Aims & Objectives: This was an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.
Study design: Interventional and observational.
Methods: A total of thirty-three (33) individuals were recruited for this study. Enrolled participants were either male or female, between 24-45 years old. All participants were presenting (self-perceived) one or several of the following: mild to moderate sleep issues, mild to moderate anxiety, stressful lifestyle.
Results: The Complete Calm system was very effective in helping participants get more sleep, have deeper sleep, experience fewer issues falling back asleep after waking up, have fewer difficulties falling asleep, and feeling more refreshed after sleeping.
Conclusion: Participants experienced substantial improvements in anxiety, stress, and sleep. These improvements demonstrate the efficacy of Complete Calm for helping individuals with the daily stressors experienced today.
Understanding Improvements in Sleep, Anxiety, and Stress Across the Trial
Participants were asked questions that focused on stress, sleep, and anxiety at baseline, study midpoint, and the conclusion of the trial. With the three-time point measurement and a single group design, a repeated measures statistical approach is most appropriate to understand improvement in the questions asked to participants. Due to the comprehensive nature of the data collected for this trial, the subsections below will focus on stress, anxiety, and sleep separately, even though the data were collected in the same survey, at the same time.
Participants were asked about the frequency and severity of the stress they experience at baseline, midpoint, and the conclusion of the trial. Below are the repeated measures ANOVA results and the means at each time point for each of the questions asked.
As noted above in the table, participants had significant improvements on each of the measures used to capture stress in this trial. This demonstrates that Complete Calm is effective in improving stress significantly across a 4 week period. Additional measures were used at the same time points to capture feelings and perceptions related to anxiety. The average responses from participants are included in Table 2 below:
One study participant reported a higher sensitivity to UV light and a related sunburn of the arm. The participant had a pre-existing condition, which in addition to the retinol gummy intake, might have caused an even higher sensitivity to UV light. After consulting with the Investigator of the study, the participant decided to discontinue the study. No other study participant reported a higher level of UV light sensitivity or a related concern.
Clinical trials for consumer brands
Citruslabs’ mission is to provide robust, affordable clinical trials for brands. We are setting new standards for creating research-backed product claims for supplements, skincare products, devices, CBD products, health foods, and superfoods.
Citruslabs’ mission is to provide robust, affordable clinical trials for brands. We are setting new standards for creating research-backed product claims for supplements, skincare products, devices, CBD products, health foods and superfoods.
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