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A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity

NCT06146712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-11-27

No results posted yet for this study

Summary

This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.

Conditions

  • Sleep

Interventions

OTHER

Asutra's 'Dream the night away' nighttime lotion

Product contains Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Sodium Lactate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Glycerin, Undecane, Cetyl Palmitate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glyceryl Stearate, Magnesium Sulfate, Melatonin, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil, Citral, Geraniol, Linalool

Sponsors & Collaborators

  • Citruslabs

    collaborator INDUSTRY

  • Asutra

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2023-10-02
Completion
2023-10-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146712 on ClinicalTrials.gov