Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2026-02-28
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Placebo
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Levagen+ PEA
75mg Levagen+ PEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Palmitoylethanolamide (PEA)
75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Trpti OEA
150mg Trpti OEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Oleoylethanolamide
150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
CPO Lavender oil
85mg CPO Lavender oil will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days.
Lavender Oil
85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Interventions
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Lavender Oil
85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Palmitoylethanolamide (PEA)
75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Oleoylethanolamide
150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
Placebo
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* Agree not to use other dietary supplements for sleep, depression, stress or anxiety other than the investigational product during entire study period.
* Agree not to change current diet and/or exercise frequency or intensity during entire study period.
* Agree to not participate in another clinical trial during the study period.
1. Sleep complaints are defined as difficulty initiating sleep, or difficulty maintaining sleep, or early-morning awakening with inability to return to sleep and causing distress or impairment in social, occupational, educational, academic, behavioural, or other important areas of functioning.)
Exclusion Criteria
* 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
* Have an unstable illness e.g. diabetes and thyroid gland dysfunction
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks week)
* Those consuming more than 500mg caffeine per day
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
18 Years
ALL
No
Sponsors
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Gencor Pacific Limited
UNKNOWN
RDC Clinical Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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RV Venkatesh
Role: STUDY_DIRECTOR
Gencor Pacific
Locations
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RDC Clinical
Brisbane, , Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EVESLE
Identifier Type: -
Identifier Source: org_study_id
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