SleepNCT07294482
The Effects on Sleep Quality of 1:4 Reishi Liquid Extract
A study testing Bristol Fungarium's 1:4 Reishi Mushroom Tincture in people with Sleep, run by Efforia, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Bristol Fungarium's 1:4 Reishi Mushroom Tincture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Bristol Fungarium's 1:4 Reishi Mushroom Tincture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bristol Fungarium's 1:4 Reishi Mushroom TinctureDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single Arm observational where participants act as their own control Receives: Dietary Supplement: Bristol Fungarium's 1:4 Reishi Mushroom Tincture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention
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
Measured: Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Sep 2025
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294482
- Sponsor's protocol ID
- 42486
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Sleep Quality of 1:4 Reishi Liquid Extract
- ClinicalTrials.gov ID
- NCT07294482
- Acronym / sponsor ID
- 42486
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Dietary Supplement: Bristol Fungarium's 1:4 Reishi Mushroom TinctureSingle Arm observational where participants act as their own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (8 listed)
- Individuals with Allergies
- Pregnant or Nursing Women
- Individuals on Anticoagulants
- Immunocompromised Individuals
- Individuals with Liver Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bristol Fungarium's 1:4 Reishi Mushroom TinctureUK-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). | Dietary supplement | Single arm where participants act as their own control |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bristol Fungarium's 1:4 Reishi Mushroom Tincture in people with Sleep, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (646-679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.