Sleep and Stress Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRDC Clinical Pty Ltd

About this trial

The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements.

The main questions it aims to answer are:

* Do these supplements improve sleep quality? * Do they reduce perceived stress levels? * Do they reduce anxiety symptoms? * What medical problems do participants have when taking these supplements?

Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress.

Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.

Eligibility criteria

Qualifiers

Generally healthy adults aged 18 and over.

Able to provide informed consent.

Score of at least 14 on the Perceived Stress Scale (PSS).

Those with a sleep complaint with a frequency of at least 2 times per week(1)

Disqualifiers

A WHO-5 Well-Being Index score ≤ 28

Those with severe sleep complaints (Insomnia Severity Index >21)

Taking prescribed sleep, depression or anxiety medication

Have a serious illness e.g. asthma, depression, anxiety disorder, bipolar disorder, insomnia, organic sleep disorders (i.e. sleep apnoea), neurological disorders such as MS, kidney disease, liver disease or heart conditions

Trial design

Treatments tested in this trial

  • Lavender Oil
  • Palmitoylethanolamide (PEA)
  • Oleoylethanolamide
  • Placebo

Treatment groups

240 Participants
are divided into 4 treatment groups

Sponsors and collaborators

RDC Clinical Pty Ltd

Lead sponsor

Gencor Pacific Limited, Hong Kong

Collaborator