Status:
COMPLETED
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
Lead Sponsor:
Asutra
Collaborating Sponsors:
Citruslabs
Conditions:
Sleep
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female aged 18-59.
- Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
- Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
- Willing to maintain their standard sleep pattern and activity level for the duration of the study.
- Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.
Exclusion
- Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
- Has extremely sensitive/irritable skin or diagnosed skin conditions.
- Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
- Women who are pregnant, breastfeeding, or attempting to become pregnant.
- Anyone unwilling or unable to follow the study protocol.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Is currently undergoing, or planning to to undergo any sleep-related procedures in the next three weeks.
- A history of severe allergic reactions including but not limited to any of the product's ingredients.
- Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06146712
Start Date
August 7 2023
End Date
October 2 2023
Last Update
November 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Citruslabs
Santa Monica, California, United States, 90404