NCT05598749

Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Evaluation of the Immunomodulation Effect of ESIT12, a Poplar-type Propolis Dry Extract and Its Efficacy in Subjects At Risk of Contracting Upper Respiratory Tract Infections (URTIs)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Fytexia · Industry
• Sex: All
• Age: 25 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The aim of the present investigation is to evaluate the immunomodulation effect of ESIT12, a poplar-type propolis dry extract standardized in polyphenols, and its efficacy in subjects at risk of contracting upper respiratory tract infections (URTIs), during a 12-week supplementation period plus 4-week follow-up. The number of onset of upper respiratory tract infections, the symptoms severity and lasting and interferences with well-being will be assessed with WURSS-24 questionnaire. The quality of life will be assessed with the SF-36 questionnaire and a testimonial. Blood immune markers will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after end of the supplementation period. The design of the study is double-blind, randomized, parallel and placebo controlled.

Conditions

• Upper Respiratory Tract Infection (URTI)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Arabic gum, sucrose and silicon dioxide mix
DIETARY_SUPPLEMENT	Verum	Propolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix)

Timeline

• Start date: 2022-12-05
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2022-10-28
• Last updated: 2024-09-25

Locations

1 site across 1 country: Spain