Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573814
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Triple-blind Placebo Controlled Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor changes in treatment emergent adverse effects
Detailed Description:
The investigational product IP Bio Gelee Royale Forte contains royal jelly which is secreted by the hypopharyngeal and mandibular glands of nurse bees Royal jelly is commonly used as a functional food due to its antibacterial anti-oxidant anti-inflammatory anti-tumor and anti-aging properties While current evidence suggests royal jelly may play a role in improving human health little is known about the effects of royal jelly on immune function Therefore the objective of this study is to investigate the efficacy of Bio Gelee Royale Forte compared to placebo on immune health in a healthy adult population with self-reported susceptibility to URTIs during cold and flu season
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None