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Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

NCT05598749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2024-09-25

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Fytexia

    lead INDUSTRY

Principal Investigators

  • Pedro Alcaraz · UCAM (Universidad Catolica San Antonio de Murcia)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-07-03
Completion
2024-07-03

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05598749 on ClinicalTrials.gov