Disturbed SleepNCT07151261
Ashwagandha for Nighttime Waking
A study testing Ashwagandha in people with Disturbed Sleep, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disturbed Sleep
- What is being tested?
- Ashwagandha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: 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
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.
Read the 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-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.
- Conditions
- Disturbed Sleep
- Being tested
- Ashwagandha, Placebo
- Keywords
- Ashwagandha, Disturbed Sleep, Waking After Sleep Onset, Oura ring
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshwagandhaDietary supplement
Also called Withania Somnifera
Sustained-Release, lower-dosage (150mg) Ashwagandha Supplement, 1 capsule 1 time per day.
PlaceboOther
This placebo does not contain any of the interventional dietary supplement. The placebo consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day.
| Study group | Role | What they receive |
|---|---|---|
| Sustained-Release Ashwagandha Supplement | Experimental | Sustained-release, lower-dosage (150mg) Ashwagandha supplement; 1 capsule 1 time per day. Receives: Dietary Supplement: Ashwagandha |
| Placebo | Placebo comparator | Placebo Supplement: Consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4
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.
Measured: From Baseline to Week 4 (28 days)
Secondary outcomes (2)
Change from Baseline in the Mean Patient-Reported Outcomes Measurement Information System (PROMIS-29) Sleep Disturbance Subdomain to Week 4
Subjective sleep disturbance measured via the PROMIS-29 Profile v2.0 Sleep Disturbance Subdomain. The raw sleep disturbance summed scores range from 4 to 20, with T-scores ranging 32.0 to 73.3, respectively. For Sleep Disturbance, higher scores indicate worse health than average.
For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.
The sleep quality question is measured as 1 "Very Good" to 5 "Very Poor." The sleep refreshing question is measured as 1 "Very Much" to 5 "Not at all." The two remaining questions problem with sleep and difficulty with sleep are both measured as 1 "Not at all" to 5 "Very Much."
Measured: From Baseline to End of Week 4 (28 days)
Change from Baseline in Mean PROMIS-29 Sleep Quality Question to Week 4
Sleep quality measured via the PROMIS-29 Sleep Quality question. Scores range from 1 "Very Good" to 5 "Very Poor"
Measured: From Baseline to End of Week 4 (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start20 Oct 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disturbed SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Goldenberg, National University of Natural Medicine
- Investigators
- Joshua Goldenberg, ND, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151261
- Sponsor's protocol ID
- ES43025
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07151261
- Acronym / sponsor ID
- ES43025
- Conditions
- Disturbed Sleep
- Keywords
- Ashwagandha, Disturbed Sleep, Waking After Sleep Onset, Oura ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained-Release Ashwagandha Supplement | Experimental | Dietary Supplement: AshwagandhaSustained-release, lower-dosage (150mg) Ashwagandha supplement; 1 capsule 1 time per day. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Supplement: Consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AshwagandhaAlso: Withania SomniferaSustained-Release, lower-dosage (150mg) Ashwagandha Supplement, 1 capsule 1 time per day. | Dietary supplement | Sustained-Release Ashwagandha Supplement |
| PlaceboThis placebo does not contain any of the interventional dietary supplement. The placebo consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day. | Other | Placebo |
Primary outcome
Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4
Time frame: 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.
2 secondary outcomes
Change from Baseline in the Mean Patient-Reported Outcomes Measurement Information System (PROMIS-29) Sleep Disturbance Subdomain to Week 4
Time frame: From Baseline to End of Week 4 (28 days)
Change from Baseline in Mean PROMIS-29 Sleep Quality Question to Week 4
Time frame: From Baseline to End of Week 4 (28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Goldenberg, ND principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha in people with Disturbed Sleep, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4 (time frame: From Baseline to Week 4 (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.