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Can a lotus seed extract help menopausal women sleep through the night?

NCT ID NCT07678359

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether a daily capsule containing lotus seed and rice germ extract, called ZenRest™, can improve sleep quality in menopausal women aged 40 to 65 who have mild-to-moderate sleep problems. Participants take either the supplement or a placebo for six weeks, and sleep is measured using questionnaires and a wearable Oura Ring. The goal is to see if this natural blend offers a safe way to ease sleep troubles linked to menopause.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lotus seed and rice germ extract blend (ZenRest™)
What this could lead to
If it works, this could offer a natural, non-hormonal option to help menopausal women sleep better.
What could go wrong
This is a small, early pilot study. The supplement may not improve sleep more than a placebo, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female, aged 40-65 years at time of enrollment * Confirmed menopausal status: (a) natural menopause (≥12 consecutive months of amenorrhea without other clinical cause), or (b) surgical menopause (bilateral oophorectomy with documented date of procedure) * Positive onboarding sleep screener: rates sleep quality as "Fairly Bad" or "Very Bad" AND reports sleep difficulty at least once per week in the prior month * PSQI global score \>5 at T0 baseline assessment (formal eligibility gate) * Owns and actively uses an Oura Ring Generation 4 at time of enrollment * Demonstrates ≥80% Oura Ring wear compliance in the 30 days prior to enrollment, confirmed via Alethios platform sync at onboarding * Willing to wear Oura Ring Generation 4 continuously for 42 nights throughout the study period * Willing to maintain stable diet, sleep habits, medications, and supplement use throughout the 42-day study period * No planned major disruptions to sleep schedule, shift work, or travel across ≥3 time zones during the study period * Access to a smartphone or computer to complete eConsent and digital questionnaires * Able to provide informed consent via the Alethios eConsent platform Exclusion Criteria: * Current use of prescription sleep medications (benzodiazepines, non-benzodiazepine hypnotics, doxepin, suvorexant) within 30 days of enrollment * Current use of melatonin supplements at doses \>1 mg/day within 14 days of enrollment * Diagnosis of a clinically significant sleep disorder requiring treatment (obstructive sleep apnea unless adequately treated and stable, restless legs syndrome, narcolepsy) * Diagnosis of a major psychiatric disorder currently requiring pharmacological treatment * Current use of hormone replacement therapy initiated within 90 days of enrollment, or any planned changes to HRT during the study (stable long-term HRT is acceptable) * Regular use of GABAergic, serotonergic, or sedating supplements (valerian, passionflower, ashwagandha, kava) within 14 days of enrollment * Shift work or schedule regularly requiring sleep between 06:00 and 22:00 * Planned travel across 3 or more time zones during the 42-day study period * Known allergy to lotus, rice, or related botanicals * Active cardiovascular, hepatic, renal, or neurological condition that in the PI's judgment would affect sleep or participant safety * Participation in another interventional study within 30 days of enrollment * In the opinion of the PI, any condition compromising participant safety or data integrity

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alethios, Inc.

    San Francisco, California, 94109, United States

    Contact Email: •••••@•••••

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