- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07294482
The Effects on Sleep Quality of 1:4 Reishi Liquid Extract
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This remotely administered decentralized trial is designed to meticulously investigate the mythical sleep-enhancing properties of Reishi mushroom, a topic that has garnered significant attention both on social media platforms and in preliminary scholarly research. With a burgeoning interest in natural remedies for sleep disorders and stress management, this study seeks to provide a scientific basis for the anecdotal evidence suggesting the efficacy of Reishi mushroom in these areas. Utilizing a 1:4 Reishi liquid extract, this trial aims to rigorously assess the impact of this ancient remedy on various sleep quality metrics and stress levels among participants.
The core objective of this online study is to offer participants the opportunity to discover personalized insights into how the Reishi tincture influences their sleep patterns and stress levels. By engaging in this research, participants will contribute to a deeper understanding of whether this natural extract can significantly enhance sleep duration, minimize nocturnal awakenings, and elevate overall restfulness, while concurrently reducing stress. This endeavor is geared towards empowering individuals with data-driven results, enabling them to make well-informed decisions regarding their sleep health and lifestyle choices.
In aiming to scientifically evaluate the effects of Reishi extract on sleep quality and stress, participants will receive detailed feedback on how the tincture impacts their unique physiological responses. This personalized approach is intended to assist participants in determining the viability of incorporating such natural supplements into their daily wellness routines.
The significance of this study lies in its potential to challenge and expand current perceptions of natural sleep aids. By substantiating the sleep-enhancing and stress-reducing capabilities of Reishi mushroom, this research could play a pivotal role in revolutionizing how individuals approach their sleep and stress management practices. Although results may vary among participants and certain limitations are to be acknowledged, the study promises to provide valuable, personalized data. This data could significantly influence participants' strategies for achieving restful sleep and effectively managing stress, ultimately contributing to improved daytime energy and overall well-being in a digitally accessible format.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Amsden
- Phone Number: 646-679-2479
- Email: help@efforia.com
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- Efforia
-
Contact:
- Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Exclusion Criteria:
- Individuals with Allergies
- Pregnant or Nursing Women
- Individuals on Anticoagulants
- Immunocompromised Individuals
- Individuals with Liver Disease
- Children and Adolescents
- Individuals with Chronic Illnesses
- Those with Mental Health Disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm where participants act as their own control
Single Arm observational where participants act as their own control
|
UK-grown organic Reishi tincture, cloned in lab.
Triple Extracted, 1: 4 Ratio via two hot water extractions and a final organic ethanol extraction to gain access to all the bioactive compounds responsible for Reishi's beneficial properties.
(1g of mushrooms to every 4ml of water).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (Past Week Version)
Time Frame: Change from baseline (Day 1-5) in perceived stress levels at 4-5 weeks after the start of the intervention
|
The Perceived Stress Scale (Past Week Version) is a modified version of the classic stress assessment tool that evaluates stress levels based on recent experiences within the last week. This scale helps in understanding how various situations have recently affected an individual's feelings and perceived stress levels. By focusing on a shorter time frame, it provides a more immediate assessment of stress, which can be particularly useful for quickly evaluating the effectiveness of stress management strategies or interventions. The tool retains its original structure, ensuring its reliability while making it more relevant for current stress evaluation. Score Range Minimum score: 0 Maximum score: 40 Score Interpretation Higher scores = worse outcome Higher scores indicate greater perceived stress |
Change from baseline (Day 1-5) in perceived stress levels at 4-5 weeks after the start of the intervention
|
|
Neuro-QOL Item Bank v1.0 -Fatigue - Short Form
Time Frame: Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention
|
This survey aims to assess the level of fatigue experienced by the participant in the past 7 days. Each question should be answered by selecting one of the five options ranging from 'Never' to 'Always'. Unabbreviated Scale Title Quality of Life in Neurological Disorders (Neuro-QoL™) Item Bank v1.0 - Fatigue - Short Form Score Range Raw score range: Most commonly used short forms: 8-40 T-score range (standardized): Typically ~30 to ~80, mean = 50, SD = 10 Score Interpretation Higher scores = worse outcome Higher scores reflect greater fatigue severity and impact |
Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention
|
|
PROMIS Sleep Disturbance Scale
Time Frame: Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the intervention
|
The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals. This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep. Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively. Unabbreviated Scale Title Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Scale Score Range Raw score range: 6-item short form: 6-30 Score Interpretation Higher scores = worse outcome Higher scores indicate greater sleep disturbance (poorer sleep |
Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 42486
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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