The Effects on Sleep Quality of 1:4 Reishi Liquid Extract
ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEfforia, Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Can read and understand English.
US resident.
Willing and able to follow the requirements of the protocol.
Disqualifiers
Individuals with Allergies
Pregnant or Nursing Women
Individuals on Anticoagulants
Immunocompromised Individuals
Trial design
Design model
Single group
Treatments tested in this trial
Bristol Fungarium's 1:4 Reishi Mushroom Tincture
Dietary supplementUK-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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single arm where participants act as their own controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived Stress Scale (Past Week Version)
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
Time frame
Change from baseline (Day 1-5) in perceived stress levels at 4-5 weeks after the start of the intervention2
Neuro-QOL Item Bank v1.0 -Fatigue - Short Form
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
Time frame
Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention3
PROMIS Sleep Disturbance Scale
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
Time frame
Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the interventionSponsors and contacts
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Source ClinicalTrials.gov