The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults

NCT06573814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-29

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Additionally, the safety and tolerability of Bio Gelee Royale Forte, as compared to placebo, will be measured by the occurrence of and/or changes in treatment emergent adverse effects.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bio Gelee Royale Forte

Two capsules of Bio Gelee Royale Forte will be taken in the morning on empty stomach once per day for 98 days.

OTHER

Placebo

Two capsules of placebo will be taken in the morning on empty stomach once per day for 98 days.

Sponsors & Collaborators

  • Medex d.o.o.

    lead INDUSTRY

Principal Investigators

  • David Crowley, PhD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Canada

Study Locations

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Entities

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 NCT06573814 on ClinicalTrials.gov