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Efficacy and safety of Escholzia tablets in adults with insomnia: a biphasic study with a randomized, placebo-controlled, double-blind, 1-month interventional, clinical trial phase (A) and a subsequent prospective, 1-armed, 2-months interventional trial phase (B).
EU CTIS ID: 2023-508169-34-00
What this study is testing
The main objective of this study is to show efficacy on perceived sleep quality and safety profile of the newly developed pharmaceutical product Escholzia tablets for the treatment of insomnia according to the ICD-10 F51.0 diagnosis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary, written, informed consent to participate in the study.
- Male or female aged between 18-65 years (inclusive).
- Diagnosis of insomnia according to ICD-10 F51.0.
- ISI total score > 7.
- Habitual bedtime between 9 pm and midnight.
- Easy access to internet for daily e-diary.
You likely can't join if
- Body mass index (BMI) <18.0 or >30.0 kg/m2.
- Have learning and/or behavioral difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness).
- History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
- Shift-workers.
- Not fluent in German.
See the full eligibility criteria
- Voluntary, written, informed consent to participate in the study.
- Male or female aged between 18-65 years (inclusive).
- Diagnosis of insomnia according to ICD-10 F51.0.
- ISI total score > 7.
- Habitual bedtime between 9 pm and midnight.
- Easy access to internet for daily e-diary.
- Freezing capacities available for storage of saliva samples.
- Body mass index (BMI) <18.0 or >30.0 kg/m2.
- Have learning and/or behavioral difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness).
- History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
- Shift-workers.
- Not fluent in German.
- 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 participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
- 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 history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder
- Any known acute history of psychiatric illness (e.g., mono- or bipolar depression, anxiety disorders, 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, dementia).
- Current or recent (within past 4 weeks) 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, etc.).
- Current or recent (within 1 year) alcohol abuse, heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day).
- Self-declared regular illicit drug use (including cannabis and cocaine).
- Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.