Sleep and Stress Study
NCT07315516 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-04-23
Summary
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.
Conditions
- Sleep Disorder (Disorder)
- Stress
- Anxiety
Interventions
- DIETARY_SUPPLEMENT
-
Lavender Oil
85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
- DIETARY_SUPPLEMENT
-
Palmitoylethanolamide (PEA)
75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
- DIETARY_SUPPLEMENT
-
Oleoylethanolamide
150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
- OTHER
-
Placebo
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Sponsors & Collaborators
-
Gencor Pacific Limited, Hong Kong
collaborator INDUSTRY -
RDC Clinical Pty Ltd
lead INDUSTRY
Principal Investigators
-
RV Venkatesh · Gencor Pacific
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-07
- Primary Completion
- 2027-02-28
- Completion
- 2027-02-28
Countries
- Australia
Study Locations
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