CompletedNot Applicable

Ashwagandha for Nighttime Waking

United States54 participantsStarted 2025-10-20

Plain-language 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 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4

Timeframe: From Baseline to Week 4 (28 days)

Trial details

NCT IDNCT07151261

SponsorNational University of Natural Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-05

View on ClinicalTrials.gov More Disturbed Sleep trials