[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07294482":3,"trial-entities:NCT07294482":93,"trial-summary:NCT07294482":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":14,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":66,"locations":69,"central_contacts":84,"overall_officials":87,"references":88,"see_also_links":89},"NCT07294482","42486","The Effects on Sleep Quality of 1:4 Reishi Liquid Extract","RECRUITING","2026-09-10","2025-12","2025-12-26","2025-09-10","Efforia, Inc","INDUSTRY",null,"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.","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.\n\nThe 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.\n\nIn 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.\n\nThe 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.",[18],"Sleep",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[23],"NA",{"count":25,"type":26},100,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"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).",[33],"Single arm where participants act as their own control",[35,39,43],{"measure":36,"description":37,"timeFrame":38},"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.\n\nScore Range\n\nMinimum score: 0\n\nMaximum score: 40\n\nScore Interpretation\n\nHigher scores = worse outcome\n\nHigher scores indicate greater perceived stress","Change from baseline (Day 1-5) in perceived stress levels at 4-5 weeks after the start of the intervention",{"measure":40,"description":41,"timeFrame":42},"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'.\n\nUnabbreviated Scale Title Quality of Life in Neurological Disorders (Neuro-QoL™) Item Bank v1.0 - Fatigue - Short Form\n\nScore Range\n\nRaw score range:\n\nMost commonly used short forms: 8-40\n\nT-score range (standardized):\n\nTypically \\~30 to \\~80, mean = 50, SD = 10\n\nScore Interpretation\n\nHigher scores = worse outcome\n\nHigher scores reflect greater fatigue severity and impact","Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention",{"measure":44,"description":45,"timeFrame":46},"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.\n\nUnabbreviated Scale Title Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Scale\n\nScore Range\n\nRaw score range:\n\n6-item short form: 6-30\n\nScore Interpretation\n\nHigher scores = worse outcome\n\nHigher scores indicate greater sleep disturbance (poorer sleep","Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the intervention",[],"ALL","18 Years",true,{"inclusion":52,"exclusion":56,"raw_text":65},[53,54,55],"Can read and understand English.","US resident.","Willing and able to follow the requirements of the protocol.",[57,58,59,60,61,62,63,64],"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","Inclusion Criteria:\n\n* Can read and understand English.\n* US resident.\n* Willing and able to follow the requirements of the protocol.\n\nExclusion Criteria:\n\n* Individuals with Allergies\n* Pregnant or Nursing Women\n* Individuals on Anticoagulants\n* Immunocompromised Individuals\n* Individuals with Liver Disease\n* Children and Adolescents\n* Individuals with Chronic Illnesses\n* Those with Mental Health Disorders",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":7,"city":72,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Efforia","New York","10003","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Matthew Amsden","CONTACT","(646) 679-2479","help@efforia.com",{"lat":82,"lon":83},40.71427,-74.00597,[85],{"name":77,"role":78,"phone":86,"email":80},"646-679-2479",[],[],[90],{"label":91,"url":92},"Additional information and join instructions on Efforia","https:\u002F\u002Fapp.efforia.com\u002Fwp-admin\u002Fadmin.php?page=llms-course-builder&course_id=42481",{"nct_id":4,"conditions":94,"biomarkers":95},[18],[],{"nct_id":4,"found":50,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll 100 participants. It is a remotely administered, decentralized trial.","completed","Reishi Mushroom Extract for Sleep and Stress","This study is looking at how a daily dose of Bristol Fungarium's 1:4 Reishi Mushroom Tincture affects your sleep and stress levels. Researchers want to see if this organic Reishi extract, taken 30 minutes before bed, can improve how long you sleep, how quickly you fall asleep, reduce nighttime awakenings, and make you feel more rested. They also want to see if it can boost your daytime energy and lower your stress. You might be able to join if you are an adult US resident, can read English, and don't have certain health conditions like allergies, liver disease, or chronic illnesses, and are not pregnant or nursing. The study will measure changes in your perceived stress and fatigue after 4-5 weeks, and sleep disturbance after 6-7 weeks.","Your perceived stress levels will be measured 4-5 weeks after starting the intervention. Your fatigue and sleep disturbance levels will be measured 6-7 weeks after starting the intervention.",127,"You would take 1ml of Reishi mushroom extract daily, 30 minutes before bed. The study will assess changes in your stress and fatigue levels after 4-5 weeks, and sleep disturbance after 6-7 weeks.","Not stated in the trial record.",[30],"v2"]