Herbal sleep aid put to the test in new study
NCT ID NCT06795776
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether Eschscholzia tablets, a herbal product, can help adults with insomnia sleep better. 104 people took either the tablets or a placebo for 4 weeks, and neither they nor the researchers knew who got which. The goal was to see if the tablets improve sleep quality and are safe to use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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104 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Nov 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Voluntary, written, informed consent to participate in the study * Self reported difficulty or maintaining sleep or waking too early, or daytime impairement or distress based on subject's information related to sleep pattern during at least the preceding month before screening. * Self reported history of disturbed sleep on at least 3 nights per week for at least the last 1 month before screening. * ≥30 min to fall asleep * ≥30 min awake during sleep time * Self-reported total sleep time of ≤ 6.5 h * ISI total score ≥ 10 * Confirmation of presence of insomnia diagnosis according to the ICD-10 F51.0/ICD-11 7A00 criteria by the physician upon anamnesis. * Reported Impact on daytime functioning associated with sleep maintenance as measured with question 7 of the ISI, Score \>= 2 * Freezing capacities available for storage of saliva samples. * Willingness and infrastructure available to run aktigraphic device (bed sensor) properly Exclusion Criteria: * Body mass index (BMI) \<18.0 or \>30.0 kg/m2. * Individual is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. * Any known acute organic disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS), circadian rhythm disorder, rapid-eye-movement behavior disorder, benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder, acute and/or chronic pain. * Any known acute or chronic psychiatric condition (e.g., severe mono- or bipolar depression, history of suicidal ideation or attempt, severe anxiety disorders, severe personality disorders, borderline personality disorder, psychoses). * Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections, renal insufficiency, hepatopathy, and dementia). * History of alcohol or drug misuse * Regular alcohol consumption exceeding 140g/week, heavy smoking (\>10 cigarettes/day), high caffeine intake (\>10 glasses/day). * Current intake of drugs that could influence sleep (e.g., psychotropic, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter sleep aids, hormone therapy, health products and oriental herbs (such as valerian, hops, passionflower, hypericum). * Have a clinically significant high/low blood pressure (systolic over 159 mmHg, resp. lower than 80 mmHg or diastolic over 99 mmHg, resp. lower than 60 mmHg). * History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation. * Shift-worker. * Not fluent in local language. * Have (known) hypersensitivity to plants from the poppy family (Papaveraceae) or known hypersensitivity to the active substance/s (Eschscholzia californica, microcrystalline cellulose, Colloidal anhydrous silica, sodium croscarmellose, glycerol distearate, caramel couleur and Ferrous(III) oxide). * Participation in another study with any investigational product within 30 days of screening and during the intervention period. * Investigator believes that the subject may be uncooperative and/or noncompliant and should therefore not participate in the study.
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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.
Contacts and locations
Locations
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Diagnostics and Consultation Center Convex
Sofia, 1680, Bulgaria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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