CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
AlphaWave® L-Theanine +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05808595
NCT05808595Phase 2Completed

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

Ethical Naturals, Inc.·interventional·Posted Apr 11, 2023·Updated May 8, 2024

In Brief

A Phase 2 clinical trial evaluating AlphaWave® L-Theanine and Placebo for Stress. Completed, enrolled 30 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress
CountriesCanada
CollaboratorsKGK Science Inc.

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 11, 2023
Enrollment StartApr 4, 2023
Primary CompletionJul 17, 2023
TodayJul 1, 2026
Enrollment to primary: 3 monthsPosted 3.2 years ago

Interventions

AlphaWave® L-Theaninedietary

One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days.

Placeboother

One capsule of Placebo will be taken twice daily for 28 days.