Effect of an Olive Leaf Extract compared to a placebo on Cold and Flu Symptoms in an AdultPopulation – A double blind, randomised controlled trial

Phase 4

• Conditions: Common Cold; Influenza virus infection; Alternative and Complementary Medicine - Herbal remedies; Infection - Other infectious diseases

• Registration Number: ACTRN12619001722189
• Lead Sponsor: Pharmactive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-06
• Study Completion: 2022-05-24
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Male and females 18-65 years old
Generally healthy - Absence of chronic sickness (EPOC, metabolic stress related diseases)
Able to provide informed consent

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 past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
Pregnant or lactating woman
People medically prescribed to take drugs 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 had treatment for cancer, HIV or chronic use of steroids
BMI >40

*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

Primary Outcome Measures

Name	Time	Method
Change in cold or flu duration as assessed by WURSS-24 scores. [Submitted daily during cold or flu symptom episode. ]

Secondary Outcome Measures

Name	Time	Method
Change in cold or flu severity[Assessed by WURSS-24 scores daily during cold or flu symptoms. ];Tolerance of product as assessed by Gastrointestinal Tolerance questionnaire [At the end of 2 week supplementation period];Any missed days from work as self reported[Reported at end of 2 week supplementation period ]