60 Day
Menopause Magic: Reishi’s Remedy for Hot Flash Harmony
| STUDY TITLE | Menopause Magic: Reishi’s Remedy for Hot Flash Harmony |
|---|---|
| Submitted under umbrella | |
| Date submitted |
- |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Love Mushrooms, Patrick Killen, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Feel like menopause is stealing your groove? Dive into the natural allure of reishi mushrooms, your secret ally in the battle against hot flashes and sleepless nights. Join our 60-day study and discover if these ancient fungi can transform menopausal blues into a symphony of wellness. Two pills a day could mean a world of difference. Explore the potential of nature’s remedy and take back control with reishi. |
| Participant engagement length |
60 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services |
Reishi 1,000–3,000 mg per day (extract): $0
|
| Outcome measures |
PROMIS Sleep Disturbance Scale NIH Toolbox® Item Bank v3.0 – Positive Affect Survey (Ages 18+) Score General Anxiety Disorder (GAD-7) Depression, Anxiety and Stress Scales (DASS-21) Survey |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this study:
Menopause can be a turbulent transition, often accompanied by a host of unwanted symptoms like sleep disturbances, anxiety, and mood swings. While folklore and social media buzz have long touted the benefits of reishi mushrooms for these symptoms, scientific scrutiny remains limited. Preliminary research hints at their potential, but rigorous studies are few. This study aims to bridge that gap and provide credible insights, offering a natural option to manage the menopausal journey.
My Objective for You:
My goal is to empower you by evaluating how daily reishi mushroom intake can impact your sleep quality, mood, and overall well-being during menopause. By participating, you'll gain personalized insights into how this natural supplement affects you, allowing you to make informed decisions about incorporating reishi into your routine.
Aims & Objectives:
This study aims to assess the efficacy of reishi mushroom pills in reducing menopausal symptoms by measuring changes in sleep disturbance, positive affect, and anxiety levels. Participants will receive personalized data, giving them the power to make informed choices about using natural supplements to enhance their quality of life during menopause.
Significance & Impact:
The significance of this study lies in its potential to validate the anecdotal claims about reishi mushrooms, providing a science-backed option for managing menopausal symptoms. While the effects may vary, the personalized results will offer each participant insights into their unique response, helping them navigate this life stage with confidence and clarity. Limitations include individual variability in supplement response and adherence to the regimen.
The Intervention
Included Products & Services
Product Name: Reishi 1,000–3,000 mg per day (extract)
Quantity included: 0
Price: $0.00
Product Description: A medicinal mushroom that supports immune function, stress resilience, and vitality.
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
To ensure the safety and well-being of potential participants, it is crucial to identify individuals who might not be suitable candidates for a trial or study. Below is a table that outlines categories of individuals who should avoid participation, along with contraindications and reasons for these recommendations.
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or Nursing Individuals | Pregnancy or lactation | Potential risks to fetus or infant development as effects on pregnant or nursing individuals might not be thoroughly studied. |
| Individuals with Severe Allergies | Known severe allergic reactions to components used in the intervention | Risk of life-threatening allergic reactions or anaphylaxis. |
| Immunocompromised Individuals | Suppressed immune system | Increased risk of adverse reactions or reduced efficacy of the intervention. |
| Individuals with Chronic Illnesses | Unstable or poorly controlled chronic conditions | Potential for exacerbation of existing conditions or interference with current treatments. |
| Individuals with a History of Mental Health Disorders | History of severe psychiatric conditions | Risk of exacerbating mental health issues or interference with psychiatric medications. |
| Individuals with Ongoing Medication Regimens | Taking medications that interact with the intervention | Risk of adverse drug interactions affecting safety and efficacy. |
| Individuals with Specific Genetic Conditions | Known genetic predispositions that may affect intervention response | Unpredictable effects or increased risk of adverse outcomes due to genetic factors. |
| Children or Adolescents | Under the age of consent | Ethical considerations and potential unknown effects on development. |
| Elderly Individuals with Multiple Comorbidities | Advanced age with multiple health issues | Increased vulnerability to adverse effects due to frailty or multiple health concerns. |
It is essential for potential participants to assess their own health status and consult with healthcare professionals before deciding to participate in any study or trial.
Study Design & Experience
Daily Activity: Take two reishi mushroom pills each morning with water for 60 days.
Assesments and frequency:- Baseline: Complete PROMIS Sleep Disturbance Scale, NIH Toolbox® Item Bank v3.0 – Positive Affect Survey, General Anxiety Disorder (GAD-7) Survey, and Depression, Anxiety, and Stress Scales (DASS-21) Survey.
- Biweekly: Complete the PROMIS Sleep Disturbance Scale, NIH Toolbox® Item Bank v3.0 – Positive Affect Survey, General Anxiety Disorder (GAD-7) Survey, and Depression, Anxiety, and Stress Scales (DASS-21) Survey.
The study titled "Reishi Mushroom Pill for Menopausal Symptom Management" is designed as a single-arm observational trial, where participants act as their own controls, a methodological approach we at Efforia refer to as a "Signal Phase" study. This trial aims to gather directional evidence of the efficacy of reishi mushroom pills in managing menopausal symptoms. Participants will partake in a structured protocol involving the daily intake of two pills each morning. This single-arm design is crucial for obtaining preliminary data, offering a baseline for understanding the potential benefits of reishi mushrooms in alleviating symptoms such as sleep disturbances, mood swings, and anxiety, which are commonly experienced during menopause.
The study experience for participants is crafted to be an enlightening and empowering journey, as outlined in the protocol overview. Participants, referred to as "fabulous Efforia participants," are provided with a detailed guide to ensure their success throughout the 60-day trial period. This includes instructions on maintaining consistency with the pill intake and utilizing personalized insights generated from their data. The study emphasizes the importance of participant engagement, highlighting the need for consistent follow-through with the tasks to ensure the reliability of the results. Privacy and data security are prioritized, ensuring participants can partake with peace of mind. Efforia encourages participants to avoid other wellness interventions during the trial to maintain the integrity of the data collected.
Participants will complete several assessments to measure the impact of the intervention on their menopausal symptoms. These include the PROMIS Sleep Disturbance Scale, NIH Toolbox® Positive Affect Survey, General Anxiety Disorder (GAD-7) Survey, and the Depression, Anxiety, and Stress Scales (DASS-21). These are administered at the start and biweekly throughout the study to monitor changes in symptoms. If a positive signal is observed, suggesting that the reishi mushroom intervention is effective, more robust study designs will be considered to further validate the findings. For more detailed information, reviewers are encouraged to consult the "Minimal Risk Umbrella protocol."
Expected sample size:In our study titled "Reishi Mushroom Pill for Menopausal Symptom Management," we have developed a statistical plan that aligns with the Minimal Risk Umbrella protocol. This overarching protocol ensures that our study design and statistical analyses adhere to the principles of minimal risk to participants, ensuring ethical and methodological rigor.
Our statistical plan includes the use of validated instruments such as the PROMIS Sleep Disturbance Scale, NIH Toolbox® Positive Affect Survey, GAD-7, and DASS-21, which will be assessed at baseline and multiple outcome time points. These measures are chosen to evaluate the impact of Reishi mushroom pills on sleep disturbances, positive affect, anxiety, and stress among menopausal individuals.
For reviewers wishing to delve deeper into our statistical plan, we advise consulting the Minimal Risk Umbrella protocol, which provides comprehensive guidelines and a standardized framework for statistical methodologies applicable to studies under this category. This protocol is designed to facilitate a consistent and thorough review process, ensuring that studies like ours maintain high standards of data integrity and participant safety.
By reviewing the Minimal Risk Umbrella protocol, reviewers will gain insights into the statistical methods, sample size considerations, data analysis techniques, and risk minimization strategies that are integral to our study's design. This alignment underscores our commitment to maintaining the safety and well-being of participants while pursuing meaningful scientific inquiry into the potential benefits of Reishi mushroom pills for menopausal symptom management.