Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upperrespiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlledtrial.

Phase 3

Completed

• Conditions: pper Respiratory Tract Infection (URTI); Upper Respiratory Tract Infection (URTI); Alternative and Complementary Medicine - Other alternative and complementary medicine; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000846921
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-27
• Study Completion: 2022-02-15
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

Male and females aged 18-65 years old
- Able to provide informed consent
- Agree not to take other supplements (e.g. Echinacea, Vitamin C, zinc) or medications (e.g. Tamiflu, Relenza) aimed at preventing URTIs for the duration of the trial (3 months).

Exclusion Criteria

- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions or chronic asthma)*
- Acute sickness experienced in the past 2 months
- Serious mood disorders or neurological disorders such as MS
- Active smokers and/or nicotine or drug abuse
- Chronic alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Pregnant or lactating woman
- People medically prescribed medications that would affect the immune and/or the inflammatory response.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participants who have participated in any other related clinical study during the past 1 month
- People with cognitive damage
- People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year

*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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified