An interventional study of DHM and Placebo in Insomnia Due to Anxiety and Fear, sponsored by University of Southern California. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by University of Southern California · Not applicable, Interventional, and Prevention
The COVID-19 pandemic and social isolation order induced stress/anxiety as well as cellphone dependence. As a result, sleep disruption and mental distress became major health concerns. Gamma-aminobutyric acid type-A receptor (GABAAR) is one of the key players in modulating sleep. Dihydromyricetin (DHM), an herbal compound, plays a role in GABAAR modulation and mitigating anxiety. The investigators' partner in China obtained 288 participants who completed the online survey to gain insight into how stress/anxiety and time spent on cellphones affected sleep and mood. The participants were then enrolled in a randomized placebo-controlled double-blind study to assess the effects of DHM on sleep and improvement on stress/anxiety and cellphone using time.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's enrollment of 288 is above the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
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Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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This arm is to evaluate DHM effects on the intervention of stress-induced insomnia during the pandemic. DHM granular preparation contains DHM 200 mg plus same excipients as placebo. The 244 participants were taken DHM granular preparation, which was dissolved in \~100 ml water for oral administration, once daily for 20 days.
Dietary Supplement: DHM
The placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
Dietary Supplement: Placebo
DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic
Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
Effect of DHM on sleep duration
Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo.
Time frame: 20 days
Effect of DHM on stress levels
Changes in stress levels reported as the difference between self-reported stress levels before and after DHM or placebo. Stress levels were scaled from 0 to 10, with 10 being the highest stress level.
Time frame: 20 days
Effect of DHM on cellphone time
Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo.
Time frame: 20 days
Effect of DHM on feelings after waking up
Changes in negative feelings after waking up, reported as the difference between the self-reported negative feelings before and after DHM or placebo. In the survey, "feelings after waking up" included negative feelings such as tense, lack of motivation, and irritable/angry. To quantify these feelings, a 'Yes' counted as -1 point, a 'No' counted as 0 points, and a 'Not sure' counted as -0.5 points. The sum of these scores were calculated as the total negative feeling after waking up. Lower score (more negative) indicated worse feelings.
Time frame: 20 days
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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