Effects of Daily Intake of Ashwagandha (Withania Somnifera) Root Extract Sustained Release (SR) Capsules 150mg on Disturbed Sleep: a Phase II, Randomized Placebo-controlled Trial With Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4
研究概览
简要总结
The purpose of this research is to evaluate the effect of a sustained-release, lower-dosage (150mg) Ashwagandha supplement to reduce disturbed sleep. 54 participants, after randomization, will take either an Ashwagandha supplement or a placebo daily for 28 days (week 4) and wear an Oura ring. The Oura ring will measure waking after sleep onset (WASO). Questionnaires to evaluate quality of life and sleep will be administered at baseline and week 4.
详细描述
Each participant will be in the study for about 5 weeks (1 preparation week and 4 weeks for the trial). Questionnaires consist of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Male and non-pregnant female adult participants must be between 18 and 65 years of age.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control, as there are unknown pregnancy risks when starting any new supplement.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy and/or bilateral oophorectomy.
- •Sleep Quality: Otherwise, healthy individuals with a raw score of 25-29 (T-score of approximately 55.0-59.9) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a, indicating at least mild sleep disturbance.
- •Sleep Hygiene: Willing to follow basic sleep hygiene protocols (dark/dim lights, quiet location/white noise, regular sleep routine, abstaining from digital activity 1 hour prior to sleep) during the Baseline week and the 28-day trial.
- •Wearable Device: Participants must be willing to comply with study procedures, including wearing the Oura Ring nightly (at least 4 nights per week) and completing questionnaires.
- •Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.
- •Willing to wear the Oura Ring for a total of 35 days (7-day base + 28 days of trial)
- •Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.
- •Willing to refrain from using sleep-promoting supplements or medications during the study, such as melatonin, antihistamines, valerian root, chamomile, magnesium, and cannabinoids (CBD).
- •Results of screening procedures/ lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
- •Willing to undergo study procedures including safety lab tests and urine pregnancy test (UPT only for women of childbearing potential).
排除标准
- •Age: Participants younger than 18 and older than 65 years of age.
- •Use of Medications: Current use of sleep-promoting or sleep-disrupting medications or supplements.
- •Diagnosed Sleep Disorder: Sleep apnea, narcolepsy, or other for which they are taking medication.
- •Other Conditions: Significant medical or psychiatric conditions that could interfere with sleep assessment.
- •Irregular Sleep Schedules: Shift workers or those with irregular sleep schedules, as well as anyone with a newborn or having a lifestyle likely to interfere with sleep patterns (eg: jet lag).
- •Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 30 days.
- •Post-menopausal female subjects on any Hormone Replacement Therapy
- •Allergies: Known allergy or hypersensitivity to any component of the study product.
- •Alcohol Intake: History or presence of excessive alcohol use (> 8 drinks per week in women and > 15 drinks per week in men within the past month) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or addiction to nicotine (current smokers/tobacco users)
- •Chronic Illness: Participants with chronic conditions such as liver disease, kidney disease, or severe cardiovascular disease or cancer, colorectal disease and/or other rare disorders that at the discretion of the Principal Investigator (PI) or Clinical Investigator (CI) may impact their safety or confound trial results
- •Other Medications: Subjects taking insulin, psychotropics, anxiolytics, sedatives, hypnotics or herbal supplements / Over the counter (OTC) product / multivitamins etc. for sleep or anxiety or any other psychological condition, or any other prescription product which has a known side effect of causing somnolence or sleep problems, within one month prior to the screening visit.
- •High-risk medications: The use of any high-risk medications with narrow therapeutic indices metabolized by cytochrome (CYP450) enzymes: Warfarin (CYP2C9), Tacrolimus/Cyclosporine (CYP3A4), Efavirenz (CYP2B6), and Codeine (CYP2D6).
- •Drugs requiring activation for efficacy: Clopidogrel (CYP2C19), Codeine (CYP2D6), and Tamoxifen (CYP2D6).
- •Participation in Other Trials: Currently participating in another interventional research study or participated in another interventional research study within 90 days of screening
- •Any condition that in opinion of the Investigator, does not justify the Subjects' participation in the study.
研究组 & 干预措施
Placebo
Placebo Supplement: Consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day.
干预措施: Placebo (Other)
Sustained-Release Ashwagandha Supplement
Sustained-release, lower-dosage (150mg) Ashwagandha supplement; 1 capsule 1 time per day.
干预措施: Ashwagandha (Dietary Supplement)
结局指标
主要结局
Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4
时间窗: From Baseline to Week 4 (28 days)
WASO is measured nightly in hours and minutes via an Oura Ring. The Oura Ring must be worn at least 4 nights per week on average from Baseline (7 days) + 28 days. Primary analysis: Change in WASO will be measured as the average of the final 4 days of Week 4 minus the average WASO of the Baseline Week. Secondary analysis: Change in WASO will be measured as the average of Week 4 minus the average WASO of the Baseline Week.
次要结局
- Change from Baseline in Mean PROMIS-29 Sleep Quality Question to Week 4(From Baseline to End of Week 4 (28 days))
- Change from Baseline in the Mean Patient-Reported Outcomes Measurement Information System (PROMIS-29) Sleep Disturbance Subdomain to Week 4(From Baseline to End of Week 4 (28 days))
- Change from Baseline in Mean PROMIS-29 Sleep Quality Question to Week 4(From Baseline to End of Week 4 (28 days))
研究者
Joshua Goldenberg
Principal Investigator
National University of Natural Medicine