30 Day

Investigating Vitahustle’s Ashwagand Gummies on Stress and Sleep

STUDY TITLE Investigating Vitahustle’s Ashwagand Gummies on Stress and Sleep
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

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Informed consent

Review

Study author

Kristin Chadwick

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol aims to investigate the influence of VitaHustle Chill Ashwagandha Gummies on stress levels and sleep quality within a 30-day period. Participants will consume the gummies daily and observe changes in their mental states and sleep patterns. The intervention won't involve any tracking devices or surveys, as it purely focuses on the intake of Ashwagandha gummies and self-observation.

Participant engagement length

30 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$30

Included products & services
VitaHustle Chill Ashwagandha Gummies: $15
Outcome measures

NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form Survey

36-Item Short Form Survey Instrument (SF-36)

Personal Feelings Survey

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

Yes

Recruitment jurisdictions

United States, United Kingdom

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

Included Products & Services

Product Name: VitaHustle Chill Ashwagandha Gummies

Quantity included: 50

Price: $15.00

Product Description: Feel your stress melt away with a clinical dose of KSM-66® Ashwagandha, L-Theanine, and Passion Flower—designed to help promote relaxation, level out mood, and improve focus. Passion Fruit flavor. 50 gummies.

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire

Logging

Logging

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