How this Study Works on Efforia

This is a single-arm, longitudinal, observational study evaluating nightly use of a standardized Ganoderma lucidum (Reishi) dual-extract tincture over 50 days. It is hosted on Efforia under the Minimal Risk Umbrella protocol. Study authors: Bristol Fungarium collaborators and Efforia platform contributors. Matthew Amsden is the principal investigator, with Dr. Viral Patel serving as the sub-investigator overseeing safety and adverse events.

While Efforia did not author this study, Efforia collaborates with the providers of the products and services included in this study. When you purchase the required items, Efforia takes a transaction fee, making this study possible.

While you could buy these products separately for a similar cost, Efforia bundles everything into one convenient purchase and adjusts your costs based on the products you’ve already purchased. We organize and provide instructions to create a seamless, data-driven research experience.

This setup helps you track your progress and understand how the products and services in this study impact your life through detailed outcome reports. It empowers you to make informed decisions about future purchases and the use of your time.

Your participation also contributes to valuable generalizable research findings, benefiting others who might not be able to afford such opportunities without guaranteed results.

Equitable inclusion: If the cost is a concern, click the Efforia logo at the top of the page to explore other protocols. We offer a range of studies at different price points, including free options.

Purpose of the Study

The purpose of this study is to evaluate whether daily use of a standardized Reishi (Ganoderma lucidum) tincture improves sleep quality and reduces perceived stress over a 50-day period. Outcomes include sleep duration, time to fall asleep (sleep latency), number of nocturnal awakenings, subjective restfulness, daytime fatigue, and perceived stress levels, assessed via standardized questionnaires and self-reports.

Products, Measures, Services, and Treatments

• Intervention: Bristol Fungarium’s 1:4 dual-extract Reishi tincture (ethanol and hot-water extraction). Dose: 1 mL nightly, ~30 minutes before bedtime, taken sublingually or diluted in water.
• Measures: Standardized participant-reported outcomes for sleep quality (e.g., sleep duration, sleep latency, number of awakenings, and restfulness) and perceived stress; adherence logs.
• Services: Efforia platform onboarding, reminders, and outcome reporting dashboards that provide both personal and pooled (group) results.
• Study Duration: 50 days of intervention with baseline and end-of-study assessments.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

After Enrollment and Checkout

Once you complete enrollment, payment (if the protocol cost is greater than $0), your personal details, shipping details (if applicable), and communication preferences:

1. Receive the intervention: If shipping is included, the Reishi 1:4 dual-extract tincture will be shipped to the address you provide.
2. Baseline assessments: Complete baseline questionnaires on sleep quality, fatigue, and perceived stress before starting the tincture.
3. Daily routine: Take 1 mL of the Reishi tincture each evening ~30 minutes before bedtime, either under the tongue or mixed in a small glass of water, for 50 consecutive days. Log adherence as prompted.
4. Follow-up assessments: At the end of Day 50, complete follow-up questionnaires to evaluate changes in sleep and stress.
5. Reporting: View personal outcome reports and, when available, aggregated findings across participants.

The Risks, Discomforts & Benefits of Being in this Study

There are unique risks, discomforts, and potential benefits to consider before joining. Not all risks are known for all personal circumstances; you should review the information below and consult a qualified healthcare professional.

Possible Serious Adverse Events & Side Effects

Risk name	Risk likelihood	Summary
Allergic reaction (rash, swelling, difficulty breathing)	Low	May occur in those allergic to mushrooms; seek emergency care if severe.
Gastrointestinal upset	Low	Possible nausea, diarrhea, or stomach discomfort.
Drowsiness or dizziness	Low	May affect ability to drive or operate machinery after dosing.
Increased bleeding risk	Low	Potential concern for people on anticoagulants or with bleeding disorders.

Some People May be at Increased Risk

Some people may be at increased risk from this study, and should not join the study before speaking with a medical or other professional with intimate knowledge of your specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated product and services outside the study.

Who may be at increased risk	Why they should not join
Pregnant, thinking of becoming pregnant, or breastfeeding	Safety of Reishi tincture during pregnancy/lactation is not established.
Individuals allergic to mushrooms	Risk of hypersensitivity or allergic reaction.
People on blood thinners or with blood-clotting disorders	Potential for increased bleeding risk.
Individuals with liver conditions	Rare reports of liver toxicity; discuss with your clinician.

Consider your Own Risk-Benefit Comfort Level

Please weigh potential risks and benefits carefully. This is a participant-sponsored research model, which places more responsibility on you to make an informed choice than a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Privacy & Security Risks

Efforia takes extensive steps to protect your privacy and confidentiality, but no system can eliminate risk entirely. Please review the Efforia privacy policy here: https://efforia.com/privacy-policy/.

• We may contact local help if we believe you may be a danger to yourself and/or others.
• Regulators (e.g., the U.S. Food and Drug Administration or similar agencies) and Institutional Review Boards may review records that include identifying information.

The Possible Benefits of Participating — Personal and Overall Findings

Efforia will provide you with personal outcome reports and contribute your de-identified results to aggregated findings. These may be made available at various points during the study. Results could influence your willingness to continue; participation is voluntary and you may exit at any time by emailing help@efforia.com.

There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.

What to do if you have a study related injury.

If you are injured or experience urgent symptoms, seek local medical care first. Efforia cannot provide emergency medical care or diagnosis. After you have received any necessary treatment, please contact Efforia to report the issue so we can assess potential risks for others: help@efforia.com.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the cace of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately.

If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

Since this study is for research only, the alternative is not to participate. If this protocol is not quite right or is too expensive for your needs, you may click the Efforia logo at the top of the page to explore other studies, including free options.

Your Rights as a Participant

Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation is completely voluntary, and you may withdraw at any time without adverse consequences. You are not giving up any rights by signing this document.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through measures designed to ensure anonymity or confidentiality, and to safeguard against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study uses placebos or controls.

The Right to Leave a Study without Penalty at Any Time

If you decide to withdraw, visit your Profile → Your Protocols → Leave. You will be refunded for consumable products not yet shipped. For non-consumable products, a full refund will be issued upon their return per our return policy.

Participant Rights (Required Language)

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.

New Information and Study Results (Required Language)

If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decided whether or not to continue participating.

Confidentiality & Privacy (Required Language)

The researchers will only use and share information that is needed for the study. The researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose for using and sharing your information is to make sure the study is done properly. By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in citizen-science clinical research, this trial is hosted by Efforia yet uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

How Efforia Makes Money: Efforia takes a transaction fee on products and services included in this protocol. Otherwise, Efforia has no financial interest in or control over the outcomes. To reduce conflicts, we will remind you once if you do not complete enrollment. We will not remarket to you or push you to join.

How we Reduce Conflicts of Interest

Participants should not have any financial relationship with the intervention or measurement providers; do not participate if you are an employee, investor, stakeholder, or protocol author associated with these entities, as this may compromise scientific integrity.

Consequences of Conflict of Interest Non-Compliance

Failure to disclose a conflict or a discovered breach may result in immediate suspension from the platform; payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

Efforia collects data you provide (e.g., questionnaires, adherence logs) to generate your personal outcomes and pooled results. Data handling follows applicable privacy laws and platform policies designed to protect confidentiality.

What you can do to improve your privacy and security

As part of participating, you will receive notifications via email, SMS, or push when new study tasks are ready. You can adjust communication preferences in the Efforia app at any time. If you do not want to receive notifications from this study, do not press the Accept button. Protect your devices and accounts with passwords or other access controls and avoid sharing your credentials. Learn more about your rights here: https://efforia.com/privacy-policy/.

Who will have access to your data?

Efforia will have access to your data. Partners directly involved in delivering services (e.g., laboratories, connected health devices) may also access necessary data to perform their functions.

What will we do with your data

Your data will be used to show your personal results and to generate aggregated, general outcomes. We will not use your information connected with your name or other direct identifiers without your permission.

California Experiential Research Subject’s Bill of Rights

• Be informed of the nature and purpose of the study.
• Receive an explanation of procedures and any potential risks or benefits.
• Ask questions and receive answers at any time.
• Leave the study at any time without penalty.

Please also review the Efforia privacy policy: https://efforia.com/privacy-policy/.

Questions or Concerns

This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
ETHICS@EFFORIA.COM

Additional questions and closing

Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.

Introduction & Summary

You are being asked to join a research study about the effects of a specific type of Reishi mushroom tincture on sleep quality and stress. Your participation is entirely voluntary. If you choose to join, you will take 1 mL of Bristol Fungarium’s 1:4 dual-extract Reishi tincture each evening for 50 days, 30 minutes before bedtime. You will complete surveys before and after the study to measure changes in your sleep, fatigue, and stress.

Purpose of the Study

The purpose of this study is to learn whether daily use of a 1:4 dual-extract Reishi tincture improves sleep quality (including duration, time to fall asleep, number of night wakings, and restfulness) and reduces perceived stress. This will help us understand whether Reishi can be a useful natural option for sleep and stress management.

What You Will Do as Part of This Study

• Take 1 mL of the Reishi tincture every evening, 30 minutes before bed, either directly under your tongue or in a small glass of water.
• Complete the baseline surveys before starting.
• Complete the follow-up surveys at the end of the 50 days.
• Let Efforia know about any side effects or problems. You may leave the study at any time by contacting help@efforia.com.

Risks, Discomforts & Benefits

Not all risks are known for all personal circumstances. Potential participants should do their own research. Participants should not operate heavy machinery within several hours of usage.

Risk name	Risk likelihood	Summary
Allergic Reaction (rash, swelling, difficulty breathing)	Low	May occur in people allergic to mushrooms. Seek emergency care if severe.
Gastrointestinal upset	Low	Possible nausea, diarrhea, or stomach discomfort.
Drowsiness or dizziness	Low	May affect ability to drive or operate machinery.
Increased bleeding risk	Low	May affect people taking blood thinners or with blood disorders.

Who Should Avoid This Study

Some people may be at increased risk. Efforia strongly discourages these individuals from joining the study. Please consult your local medical professional before proceeding.

Category	Why
Pregnant, planning pregnancy, or breastfeeding	Safety not established
Allergic to mushrooms	Risk of allergic reaction
On blood thinners or with blood clotting disorders	Increased bleeding risk
With liver conditions	Rare reports of liver toxicity

Possible Benefits

You may experience improved sleep quality, less stress, and better daytime energy. The study may also help others by contributing to research on natural sleep and stress remedies. Benefits are not guaranteed.

Privacy & Confidentiality

Your personal information and responses will be kept confidential, stored securely, and used only for research purposes. Results may be shared publicly in a way that does not identify you.

Study-Related Injury Care & Compensation

Efforia will not offer financial compensation or free medical care if you are injured from participating. You are responsible for any medical costs.

In Case of Medical Emergency

Seek immediate medical care by calling emergency services (for example, 999 in the UK). Inform Efforia afterward by emailing help@efforia.com.

Alternatives to Participation

You may choose not to participate. You can purchase and use Reishi tincture outside of this study without completing the study activities.

Your Rights as a Participant

• Right to Privacy: Your data will be kept secure and confidential.
• Right to Your Results: You will have access to your individual study results.
• Right to Withdraw: You may leave the study at any time without penalty.

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.

If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.

Data Protections

What You Can Do to Improve Privacy

Use a secure device and internet connection to complete surveys.

Who Will Have Access to Your Data

Only the research team and authorized Efforia staff.

What Will We Do With Your Data

Your de-identified data may be used in future research and shared with the public.

Confidentiality & Privacy (Required Language)

The researchers will only use and share information that is needed for the study. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records. Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose of using and sharing your information is to make sure the study is done properly. Signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.

California Experiential Research Subject’s Bill of Rights

• Be informed of the nature and purpose of the study.
• Receive an explanation of procedures and any potential risks or benefits.
• Ask questions and receive answers at any time.
• Leave the study at any time without penalty.

Questions or Concerns

For questions about the study, contact: help@efforia.com
For questions about your rights as a participant, contact: ethics@efforia.com