The effect of Palmitoylethanolamide (PEA) supplementation on the symptoms of allergic rhinitis - A double-blind placebo controlled trial.

Phase 3

Completed

• Conditions: Allergic rhinitis; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12619001368123
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-08
• Study Completion: 2022-02-11
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Male and females over 18 years old
Reporting seasonal allergic rhinitis
Generally healthy
Able to provide informed consent
Females using a prescribed form of birth control birth control, abstinent or post-menopausal
Agree not to change current diet/exercise or not to use other supplements/products for allergy
relief other than the test product during study period.
A score of 3 or more on at least 4 of the 7 baseline days for the 24 hour score on the rTNSS #

# Participants will undertake 7 days of rTNSS and continue to take supplement once they fulfil the
rTNSS score requirement.

Exclusion Criteria

Unstable or serious illness (e.g. MS, kidney, liver, GIT, heart conditions, diabetes, thyroid
gland function Malignancy) including mental/mood disorders (e.g. depression and bipolar)*
Malignancy or treatment for malignancy within the previous 2 years
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
anticoagulation therapy
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (consumption of more than 14 standard alcoholic drinks per week)
Allergic to any of the ingredients in active or placebo formula
Pregnant or lactating woman §
Any condition which in the opinion of the investigator makes the participant unsuitable for
inclusion

* An unstable illness is any illness that is currently not being treated with a stable dose of medication
or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively
impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
§ Participants who have any reason to feel there is any possibility they are pregnant will be offered a
pregnancy test to undertake before continuing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in allergy symptoms - Reflective total nasal symptom score 12 hour (TOTAL rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose.[Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3]

Secondary Outcome Measures

Name	Time	Method
Reflective individual nasal symptom scores (Individual rTNSS)[Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3];Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score[Baseline & Week 3];Change in biochemistry markers from baseline as assessed by serum assay - cytokines, hs-CRP, FBC, histamine, E/LFT[Baseline & Week 3];Onset of action (when did symptoms start to improve) by analysis of reflective total nasal symptom score 12 hour (TOTAL rTNSS).[Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3]