Status:
RECRUITING
Ashwagandha for Nighttime Waking
Lead Sponsor:
National University of Natural Medicine
Conditions:
Disturbed Sleep
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ei...
Detailed Description
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-2...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07151261
Start Date
October 20 2025
End Date
March 31 2026
Last Update
December 29 2025
Active Locations (1)
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1
National University of Natural Medicine
Portland, Oregon, United States, 97201