A Phase 2 interventional study of Lavender Oil and Palmitoylethanolamide (PEA) in Sleep Disorder (Disorder), Stress and Anxiety, sponsored by RDC Clinical Pty Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by RDC Clinical Pty Ltd · Phase 2, Interventional, and Treatment
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:
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.
The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial This four-arm, parallel-group trial evaluates bioactive compounds targeting stress-sleep pathophysiology (lavender oil, PEA, and OEA). The 8-week intervention employs validated psychometric instruments alongside salivary biomarkers providing objective HPA axis and circadian rhythm assessment. The trial enrolls 240 participants (60 per arm) with moderate stress (PSS ≥14) and sleep complaints.
Agree to not participate in another clinical trial during the study period.
Exclusion Criteria:
85mg CPO Lavender oil will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Dietary Supplement: Lavender Oil
75mg Levagen+ PEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Dietary Supplement: Palmitoylethanolamide (PEA)
150mg Trpti OEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Dietary Supplement: Oleoylethanolamide
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Other: Placebo
85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Also known as: CPO Lavender oil
75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Also known as: Levagen+
150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
Also known as: Trpti
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Perceived stress via Perceived Stress Scale (PSS)
Change from baseline to the end of the study period in Perceived stress via Perceived Stress Scale (PSS). The Perceived Stress Scale is a self-reported tool for measuring psychological stress. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress.
Time frame: Day 1 to day 57
Anxiety via Beck Anxiety Inventory (BAI)
Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire evaluating anxiety symptoms, rated on a 4-point scale.
Time frame: Day 1 to day 57
Sleep quality
Change from baseline to the end of the study period in Sleep quality. This will be measured via Pittsburgh Sleep Quality Index (PSQI) and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Time frame: Day 1 to day 57
Mental wellbeing
Change from baseline to the end of the study period in Mental wellbeing via The World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being. A score ≤ 50 (or \< 13 in the raw score) is associated with poor well-being or psychological distress and a score ≤ 28 may denote possible clinical symptoms of depression.
Time frame: Day 1 to day 57
Mood
Change from baseline to the end of the study period in Mood via Profile of mood states (POMS). The POMS is a self-reported questionnaire consisting of 65 items, designed to evaluate individuals within seven different mood domains: fatigue-inertia, anger-hostility, vigor-activity, confusion-bewilderment, depression-dejection, tension-anxiety, and friendliness.
Time frame: Day 1 to day 57
Sleep duration
Change from baseline to the end of the study period in Sleep duration via PSQI and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Time frame: Day 1 to day 57
Sleep onset latency
Change from baseline to the end of the study period in Sleep onset latency as measured by duration of time (minutes) from turning light off to falling asleep (PSQI and Consensus Sleep Diary). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Time frame: Day 1 to day 57
Sleep efficiency
Change from baseline to the end of the study period in Sleep efficiency as measured by ratio of total sleep time to time in bed (PSQI). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time frame: Day 1 to day 57
Daytime sleepiness
Change from baseline to the end of the study period in Daytime sleepiness via Functional Outcomes of Sleep Questionnaire (FOSQ-10). The FOSQ-10 consists of 10 items distributed among 5 subscales i.e. general productivity (2 item), activity level (3 items), vigilance (3 items), social outcomes (1 item) and sexual relationship (1 item). Items are rated on a scale of 1-4 (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, 4 = no difficulty). The total score is the sum of the 5 sub scores.
Time frame: Day 1 to day 57
Eating in response to experienced stress
Change from baseline to the end of the study period in Eating in response to experienced stress via the Salzburg Stress Eating Scale (SSES). The SSES is a questionnaire use to measure eating in response to experienced stress. The response categories range from 'I eat much less than usual' to 'I eat much more than usual' and are scored on a 5-point Likert scale, i.e., a score from 1 - 5. Higher scores indicate that the respondent eats more when stressed is experienced.
Time frame: Day 1 to day 57
Serotonin
Change from baseline to the end of the study period in serotonin via saliva test.
Time frame: Day 1 to day 57
Cortisol
Change from baseline to the end of the study period in cortisol via saliva test.
Time frame: Day 1 to day 57
Melatonin
Change from baseline to the end of the study period in melatonin via saliva test.
Time frame: Day 1 to day 57
Safety via AE monitoring
Change from baseline to the end of the study period in Safety via AE monitoring
Time frame: Day 1 to day 57
Safety via vital signs (blood pressure)
Change from baseline to the end of the study period in safety via vital signs (blood pressure).
Time frame: Day 1 to day 57
Safety via vital signs (heart rate)
Change from baseline to the end of the study period in safety via vital signs (heart rate).
Time frame: Day 1 to day 57
Safety via vital signs (O2 saturation)
Change from baseline to the end of the study period in safety via vital signs (O2 saturation).
Time frame: Day 1 to day 57
Safety via vital signs (temperature)
Change from baseline to the end of the study period in safety via vital signs (temperature).
Time frame: Day 1 to day 57
Plan to share: Undecided
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RDC Clinical Pty Ltd