Clinical trial NCT06795776: Eschscholzia Study
Official title: Efficacy and Safety of Eschscholzia Tablets in Adults with Insomnia Disorder Symptoms: a Monocentric, Randomized, Double-blind, Placebo-controlled, Parallel Group, Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Sleep
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
Collaborators: name: DCC Convex Ltd.
First posted: 2025-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study aimed at evaluating the efficacy and safety of Eschscholzia tablets in adults with insomnia disorder symptoms. The study will be conducted at one center, participants will randomly be assigned to either the treatment or placebo. Neither the participants, nor the researchers will know who is receiving the treatment (double-blind). The study is also placebo-controlled, meaning some participants receive a dummy pill instead of the actual treatment, and it involves a parallel-group design, where the treatment and placebo groups are studied at the same time. The study is exploratory, meaning it is investigating new possibilities and is not yet fully conclusive.

The purpose of this study is to determine main efficacy and safety of the newly developed herbal medicinal product Eschscholzia tablets. A total of 100 subjects will be enrolled in the study and assigned to either Eschscholzia tablets or placebo.

The Local Ethics Committee at the clinical site has given their approval for the study to be run.

Male or female participats aged between 18 and 75 years (inclusive), generally healthy and with a self reported history of disturbed sleep on at least 3 nights per week for at least the prior 1 month with a self-reported impact on daytime functioning are allowed to take part in the study.

Overall, the study has the following visits in the clinic, planned for each patient: Screening visit, Study centre Visit 2, Final study centre Visit 3. Between these visits participants will go through a "run-in" period (1 week between Visit 1 and 2) and treatment period (1 month between visit 1 and 3), both at home. Upon visit 2 participants will obtain the study product. They will be asked to administer a daily dose of 2 tablets (either Eschscholzia tablets or Placebo) over a 4-week period, starting from Visit 2 and continuing until Visit 3. Every intake of study product should be noted on the sleep diary pages that the participants obtain.


Eligibility criteria: 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.

Primary outcomes:
measure: Change between baseline and over 4-week treatment phase for perceived sleep quality as measured with the Insomnia Severity Index (ISI)
timeFrame: Change between baseline and over 4-week treatment phase
measure: Change in perceived sleep quantity/quality as per the daily sleep diary
timeFrame: Change between baseline and over 4-week treatment phase
Secondary outcomes:
measure: Change in physiological sleep quantity and quality as measured via actigraphy (bed sensor)
timeFrame: Change between baseline and over 4-week treatment phase
measure: ISI Responder criteria assessed at the end of intervention on visit 3
timeFrame: On Day 36
measure: Change in daytime sleepiness symptoms severity as measured with the Epworth Sleepiness Scale (ESS)
timeFrame: Change between baseline and over 4-week treatment phase
measure: Change in Profile of Mood states as measured with the POMS-2 questionnaire (POMS-2)
timeFrame: Change between baseline and over 4-week treatment phase
measure: Change in state anxiety as measured with the State-Trait-Anxiety-Inventory (STAI-Y1/Y2)
timeFrame: Change between baseline and over 4-week treatment phase
measure: Change in anxiety disorders as per the assessment of the clinician on the HAM-A scale (HAM-A)
timeFrame: Change between baseline and over 4-week treatment phase
measure: Change in psychological well-being as measured with the Depression, Anxiety, and Stress Scale (DASS-21).
timeFrame: Change between baseline and over 4-week treatment phase
measure: Subjective efficacy
timeFrame: Day 36
measure: Subjective tolerability
timeFrame: On Day 36
measure: Acceptance of the treatment
timeFrame: On day 36
measure: Rate/kind of adverse events
timeFrame: on day 36
measure: Blood pressure
timeFrame: Change between baseline and day 36
measure: Blood pulse
timeFrame: Change between baseline and day 36
measure: Change in Blood safety parameters
timeFrame: Change between baseline and day 36
measure: Rate/kind of comedication
timeFrame: Change between baseline and day 36
measure: Treatment compliance
timeFrame: on day 36
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Diagnostics and Consultation Center Convex
Study officials:
References: