Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). Palmitoylethanolamide (PEA) as Levagen+ will be taken as 2 x 300 mg capsules per day – 1 capsule in the morning, 1 capsule in the evening for the duration of the intervention period (3 months). During the 3‐month study period, participants will be asked to complete a SF‐8 questionnaire every 4‐weeks. Additionally, if a participant experiences the onset of URTI symptoms (e.g. cough, sneezing, stuffy or runny nose, fever, scratchy or sore throat and nasal breathing), participants will then be required to record their daily symptoms (including the severity) online using the WURSS‐24 questionnaire for the duration of the event or up to 2‐weeks. Participants are required to continue taking their study product while they are experiencing symptoms. If a participant’s symptoms continue for more than 2‐weeks, they will be asked to stop recording the event and seek medical advice (GP). Once symptoms of an event have subsided, participants are asked to continue to take the trial product for the remaining duration of the study period (up to 3‐months total) and record any subsequent URTI episodes. Adherence will be monitored by return and logging of any remaining study product at completion of intervention period. CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Respiratory ‐ Other respiratory disorders / diseases Upper Respiratory Tract Infection (URTI); ; Upper Respiratory Tract Infection (URTI) PRIMARY OUTCOME: Upper respiratory tract infection (URTI) incidence via submission of symptomatic ; Wisconsin Upper Respiratory Symptom Survey (WURSS‐24)[Month 3 ] SECONDARY OUTCOME: Change in general health via sf‐8 questionnaire[Baseline, Month 1, Month 2 and Month 3. ] Change in URTI severity via WURSS‐24[Baseline, daily from day 2‐14 of cold or flu episode.] Days off work via WURSS‐24 questionnaire[Baseline, daily from day 2‐14 of cold or flu episode.] Product tolerance/adverse events (e.g. Gastrointestinal upset, however there are currently no reported adverse events to PEA on the Therapeutic Goods Administration (TGA) register) to be assessed via SF‐8 questionnaires every 4 weeks as well as adverse events either spontaneously reported by the participant, or noticed by an investigator. [Baseline, Month 1, Month 2 and Month 3 or when spontaneously reported by the participant. ] URTI duration via submission of symptomatic WURSS‐24[Baseline, daily from day 2‐14 of cold or flu episode.] 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).
Epistemonikos ID: 5ea4d01df78d37d252d8ff295fcd2dd8c1f2afe6
First added on: Aug 24, 2024