Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 6:47 AM
Study NCT ID:
NCT05808595
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
Sponsor:
Ethical Naturals, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: