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NCT06146712

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

Completed NA Last updated 27 November 2023
What this trial tests

NA trial testing Asutra's 'Dream the night away' nighttime lotion in Sleep in 35 participants. Completed in 2 October 2023.

Timeline
7 August 2023
Primary endpoint
2 October 2023
2 October 2023

Quick facts

Lead sponsorAsutra
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment35
Start date7 August 2023
Primary completion2 October 2023
Estimated completion2 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Asutra

Who can join

Adults 18 to 59, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06146712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing