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Recruiting NCT07294482

The Effects on Sleep Quality of 1:4 Reishi Liquid Extract

No phase Interventional Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bristol Fungarium's 1:4 Reishi Mushroom Tincture.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Examining the effects of 1ml of Reishi mushroom extract (1:4 extraction ratio, two hot water extractions and an alcohol extraction), taken daily, 30 mins before bed on perceived sleep quality and stress levels. Sleep quality includes: duration, sleep onset latency, nighttime wakings, and perceived restfulness. And consequently, the potential for increased daytime energy levels and a reduction in perceived stress levels.

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.

Interventions

  • Dietary supplement Bristol Fungarium's 1:4 Reishi Mushroom Tincture
    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).

Primary outcome measures

  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Efforia — New York

Identifiers

NCT: NCT07294482 · 42486

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗