SleepPhase 3NCT06795776
Eschscholzia Study
A Phase 3 study testing Eschscholzia tablets in people with Sleep, run by A. Vogel AG at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep
- What is being tested?
- Eschscholzia tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBulgaria
- Study dates
- 7 Apr 2025to 4 Nov 2025
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read more
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.
- Conditions
- Sleep
- Being tested
- Eschscholzia tablets, Placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eschscholzia tabletsDrug
The intervention will be provided as swallowable "Eschscholzia tablets" (1.0 g) containing 0.503g Eschscholzia californica Herba rec. tinct. conc. as the active pharmaceutical ingredient (API) corresponding 600 mg powdered herbal material.
Placebo TabletsDrug
A placebo tablet will be provided that matches the verum in its optical and sensorial properties and posology. Contains: microcrystalline cellulose, Colloidal anhydrous silica, glycerol distearate, caramel couleur and colorants.
| Study group | Role | What they receive |
|---|---|---|
| Verum Group: Eschscholzia tablets | Experimental | One Escholzia tablet (1.0 g) contains as active pharmaceutical ingredient:
0.503 g Eschscholzia californica Herba rec. tinct. conc. as the active pharmaceutical ingredient (API) corresponding 600 mg powdered herbal material. Receives: Drug: Eschscholzia tablets |
| Control Group: Placebo tablets | Placebo comparator | A placebo tablet will be provided that matches the verum in its optical and sensorial properties and posology. Contains: microcrystalline cellulose, Colloidal anhydrous silica, glycerol distearate, caramel couleur and colorants. Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline over the 4-week treatment phase in perceived sleep quality, as measured by the summed area under the curve (summed up ISI AUC) of the Insomnia Severity Index (ISI) Total Score.
Min: 0 score points, Max: 28 score points Lower scores mean better outcomes
The global effect of the investigational medicinal product (IMP) on sleep will be evaluated using the area under the curve (AUC) of repeatedly measured subjective insomnia severity, assessed by the ISI Total Score.
Measured: Change between baseline and over 4-week treatment phase
Change in perceived sleep quality over time during the treatment period, as assessed by the longitudinal profile of the change from baseline in ISI total score values at each post-baseline assessment time point
Endpoint evaluates changes in perceived sleep quality over time during treatment based on Insomnia Severity Index (ISI) change from baseline at each scheduled post-baseline assessment time point.
Measured: From baseline over the phase of the 4 weeks treatment
Secondary outcomes (24)
Time to reach a clinically relevant insomnia symptom severity reduction of -9 units on the ISI total score scale
Endpoint evaluates the time to response (TTR), defined as the first study day on which a subject achieves a clinically relevant reduction in insomnia severity, corresponding to a change from baseline of Δ ISI ≤ -9 points.
Measured: From baseline over the phase of the 4 weeks treatment
Change in perceived sleep quality over time during the treatment and post-treatment period, as assessed by ISI AUC values at each intervention time point.
The secondary efficacy parameter ISI AUC over time is defined as the baseline-adjusted ISI AUC values calculated between consecutive assessment time points.
ISI AUC values are available for the post-baseline intervention and follow-up visits on Days 9, 11, 15, 22, 29, and 36. Baseline adjustment is performed.
A decrease (negative value) in ISI AUC is associated with a positive treatment effect, whereas an increase (positive value) indicates a negative treatment effect
Measured: From baseline over the phase of the 4 weeks treatment
Change in perceived overall sleep quality over time during the treatment, as assessed by the sleep diary composite score TSQ1
The Total Sleep Quality Index 1 (TSQ1) is a composite parameter derived from daily sleep diary entries and is intended to quantify overall perceived sleep quality over time. TSQ1 is calculated at each diary time point as the arithmetic mean of four sleep quality subscores: Sleep Enjoyment, Well Rested, Physical Tension, and Psychological Tension. Each subscore is normalized to a common scale ranging from 0 to 100, with higher values indicating better sleep quality. For subscores reflecting negative aspects of sleep (physical and psychological tension), reverse coding is applied prior to normalization to ensure consistent score directionality.
The resulting TSQ1 score ranges from 0 to 100, where higher values indicate better perceived sleep quality
Measured: From baseline over the phase of the 4 weeks treatment
Change in perceived overall sleep quality over time during the treatment, as assessed by the sleep diary subscores
Patients will complete the daily diary from study day 2 throughout the whole study duration until the morning of study day 36.
Sleep quality is assessed with four NRS (scale from 0 (very low) to 10 (very high)) with the parameters: physical tension (QPHY_D), psychological tension (QPSY_D), sleep enjoyment (QEnj_D) and restedness (QRest_D) and sleep quality (SQ_D). Further, the number of awakenings (NWAK_D), duration of awakenings (DWAK_D), sleep onset latency (SOL_D) is assessed.
Measured: From baseline over the phase of the 4 weeks treatment
ISI Responder criteria assessed at the end of intervention on visit 3
ISI Responder criteria assessed at the end of intervention on visit 3 (day 36):
- Ratio of subjects with a ISI score reduction of ≥ -5 points from baseline,
- ratio of subjects achieving a ISI score reduction of at least 50% from baseline,
- Proportion of subjects reaching an ISI total score of ≤ 7, indicating no clinically significant insomnia symptoms,
- Proportion of subjects achieving the ISI composite score. ISI composite score criteria: the ISI composite score will be considered achieved if a subject meet at least two of the responder criteria a)-c);
Measured: From baseline to the end of treatment after 4 weeks treatment
Change between baseline and over 4-week treatment phase in daytime sleepiness symptoms severity as measured with the Epworth Sleepiness Scale (ESS)
Min: 0 score points, Max: 24 score points Lower scores mean better outcomes
Measured: From baseline to the end of the treatment after 4 weeks
Change between baseline and over 4-week treatment phase in Profile of Mood states as measured with the POMS-2 questionnaire (POMS-2).
The POMS-2 includes the following primary scales:
Tension-Anxiety Depression-Dejection Anger-Hostility Fatigue-Inertia Confusion-Bewilderment Vigor-Activity (positive scale)
Higher raw scores on negative scales indicate greater mood disturbance. Higher raw scores on the Vigor-Activity scale indicate positive mood states.
Measured: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in state anxiety as measured with the State-Trait-Anxiety-Inventory (STAI-Y1 & Y2).
STAI-Y1: Measures state anxiety (temporary and situational anxiety). STAI-Y2: Measures trait anxiety (general and long-standing anxiety tendencies).
Both STAI-Y1 \& STAI-Y2 are individually assessed as follows
Minimum Score: 20 (low anxiety) Maximum Score: 80 (high anxiety)
Lower scores mean better outcomes
Measured: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in anxiety disorders as per the assessment of the clinician on the HAM-A scale (HAM-A).
Minimum Score: 0 (no anxiety) Maximum Score: 56 (severe anxiety) Lower scores mean better outcomes
Measured: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in psychological well-being as measured with the Depression, Anxiety, and Stress Scale (DASS-21).
has 21 items, diivided into three subscales:
Depression (7 items) Anxiety (7 items) Stress (7 items)
Minimum Score per Subscale: 0 Maximum Score per Subscale (adjusted): 42
lower scores mean better outcomes
Measured: Change between baseline and over 4-week treatment phase
Subjective efficacy
Patient's perceived efficacy will be assessed upon final visit 3 by asking the question how the subjects would rate the effectiveness of the study product to treat insomnia, sleeping problems and/or accompanying symptoms on a scale: "bad" = 0, "average" = 1, "good" = 2, "very good" = 3.
Measured: Day 36
Acceptance of the treatment
Patient's perceived acceptance is assessed upon final visit V3 by asking "would you take the test medication again to treat insomnia, sleeping problems and/or accompanying symptoms? Answers possible: "yes" or "no".
Measured: On day 36
Subjective tolerability
Patient's perceived tolerability will be assessed upon final visit 3 by asking the question how they rate their self-perceived tolerability of the IP on a scale: "bad" = 0, "average" = 1, "good" = 2, "very good" = 3.
Measured: On Day 36
Change between baseline and over 4-week treatment phase in physiological sleep quantity and quality and physiological measures via actigraphy (wearable).
In this study, actigraphy sleep data will be delivered using the multi-sensory Fitbit tracker "Fitbit Charge 6" Actigraphic parameters, which are recorded on a daily basis, will be handled and analysed in general consistency with the sleep diary data
- Data log data are averaged daily for all parameters applicable
Parameters:
- Minutes to Sleep onset (SOL_A)
- Minute Time in bed (TIB_A)
- Minutes Total sleep time (TST_A)
- Minutes spent in deep sleep phase (DEEP_A) from "sleep stages Day merged"
- Minutes spent in deep sleep phase (DEEP_A_30s) from "30 seconds Sleep Stages merged"
- Minutes spent in rapid-eye-movement sleep phase (REM_A) from "sleep stages Day merged"
- Minutes spent in rapid-eye-movement sleep phase (REM_A_30s) from "30 seconds Sleep Stages merged"
- Minutes spent in light sleep phases (LIGHT_A) from "sleep stages Day merged"
- Minutes spent in light sleep phases (LIGHT_A_30s) from "30 seconds Sleep Stages merged"
- Count awakenings (NWAK_A) from "sleep stages
Measured: Change between baseline and over 4-week treatment phase
Rate/kind of adverse events
Measured: on day 36
Blood pressure
Blood pressure (BP):
Systolic and diastolic BP will be assessed by using an automated BP measurement device.
Measured: Change between baseline and day 36
Blood pulse
Blood pulse will be assessed by using an automated measurement device
Measured: Change between baseline and day 36
Change in Blood safety parameters
The following factors will be analysed as per standard normal ranges for adults (f/m) by an external independent and certified medical diagnostic laboratory:
- Red blood cell counts
- Leukocytes counts /White blood cell count
- Lymphocyte count
- Thrombocyte count /Platelet counts
- Monocyte count
- Granulocyte count
- Hemoglobin levels
- Hematocrit levels
- Mean corpuscular volume
- Mean corpuscular hemoglobin
- Mean corpuscular hemoglobin concentration
- Glutamat-pyruvat-transaminase (GPT)
- Glutamat-oxaloacetate-transaminase (GOT)
- Gamma-glutamyltransferase (GGT)
- Total bilirubin
- Creatinine
- Blood Glucose
- Total Cholesterol
- Erythrocyte sedimentation rate (ESR)
- C-reactive protein (CRP)
Measured: Change between baseline and day 36
Rate/kind of comedication
Measured: Change between baseline and day 36
Treatment compliance
Upon Visit 3, product intake compliance will be verified by counting the remaining tablets of the study product returned by subjects.
Limits for subjects to be compliant is an intake of study product within 80% - 120% of the intended study product intake schedule.
Measured: on day 36
Change in biomarker for stress between baseline and over 4-week treatment phase via the salivary evening cortisol levels (8 p.m.)
Assessed at 8 p.m. ±20 minutes and delivered by the analytical laboratory
Parameters:
- Evening cortisol level
Measured: Change from baseline days 6/7 to chronic treatment after days 34/35
Change in biomarker for sleep readiness between baseline and over 4-week treatment phase via the salivary evening melatonin level (8 p.m.)
Assessed at 8 p.m. ±20 minutes and delivered by the analytical laboratory
Parameters:
- Evening melatonin level
Measured: Change from baseline days 6/7 to chronic treatment by days 34/35
Change between baseline and over 4-week treatment phase in ratio of biomarker evening melatonin level/ evening cortisol level (8 p.m.)
Assessed at 8 p.m. ±20 minutes and delivered by the analytical laboratory. Ratio = Evening melatonin level/Evening Cortisol level
Measured: Change from baseline days 6/7 to chronic treatment by days 34/35
Change between baseline and over 4-week treatment phase in biomarker for chronic stress via the CAR determined
Assessed at 8 p.m. ±20 minutes and delivered by the analytical laboratory. The saliva samples in the morning are collected three times in the first hour after waking (at awakening as well as 30 and 45 min after awakening) to assess the CAR as a physiological reaction to awakening.
The area under the curve (1) with respect to ground (AUCG), and (2) with respect to increase (AUCI) is calculated using the following formulae (Pruessner and colleagues, 2003):
Measured: Change from baseline days 6/7 to chronic treatment by days 34/35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start7 Apr 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DCC Convex Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795776
- Sponsor's protocol ID
- 5'000'642
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be sharaable upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06795776
- Acronym / sponsor ID
- 5'000'642
- Conditions
- Sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Collaborators
- DCC Convex Ltd.
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 28 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Group: Eschscholzia tablets | Experimental | Drug: Eschscholzia tabletsOne Escholzia tablet (1.0 g) contains as active pharmaceutical ingredient: 0.503 g Eschscholzia californica Herba rec. tinct. conc. as the active pharmaceutical ingredient (API) corresponding 600 mg powdered herbal material. |
| Control Group: Placebo tablets | Placebo comparator | Drug: Placebo TabletsA placebo tablet will be provided that matches the verum in its optical and sensorial properties and posology. Contains: microcrystalline cellulose, Colloidal anhydrous silica, glycerol distearate, caramel couleur and colorants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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).
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 |
|---|---|---|
| Eschscholzia tabletsThe intervention will be provided as swallowable "Eschscholzia tablets" (1.0 g) containing 0.503g Eschscholzia californica Herba rec. tinct. conc. as the active pharmaceutical ingredient (API) corresponding 600 mg powdered herbal material. | Drug | Verum Group: Eschscholzia tablets |
| Placebo TabletsA placebo tablet will be provided that matches the verum in its optical and sensorial properties and posology. Contains: microcrystalline cellulose, Colloidal anhydrous silica, glycerol distearate, caramel couleur and colorants. | Drug | Control Group: Placebo tablets |
Primary outcome
Change from baseline over the 4-week treatment phase in perceived sleep quality, as measured by the summed area under the curve (summed up ISI AUC) of the Insomnia Severity Index (ISI) Total Score.
Time frame: Change between baseline and over 4-week treatment phase
Min: 0 score points, Max: 28 score points Lower scores mean better outcomes The global effect of the investigational medicinal product (IMP) on sleep will be evaluated using the area under the curve (AUC) of repeatedly measured subjective insomnia severity, assessed by the ISI Total Score.
Change in perceived sleep quality over time during the treatment period, as assessed by the longitudinal profile of the change from baseline in ISI total score values at each post-baseline assessment time point
Time frame: From baseline over the phase of the 4 weeks treatment
Endpoint evaluates changes in perceived sleep quality over time during treatment based on Insomnia Severity Index (ISI) change from baseline at each scheduled post-baseline assessment time point.
24 secondary outcomes
Time to reach a clinically relevant insomnia symptom severity reduction of -9 units on the ISI total score scale
Time frame: From baseline over the phase of the 4 weeks treatment
Change in perceived sleep quality over time during the treatment and post-treatment period, as assessed by ISI AUC values at each intervention time point.
Time frame: From baseline over the phase of the 4 weeks treatment
Change in perceived overall sleep quality over time during the treatment, as assessed by the sleep diary composite score TSQ1
Time frame: From baseline over the phase of the 4 weeks treatment
Change in perceived overall sleep quality over time during the treatment, as assessed by the sleep diary subscores
Time frame: From baseline over the phase of the 4 weeks treatment
ISI Responder criteria assessed at the end of intervention on visit 3
Time frame: From baseline to the end of treatment after 4 weeks treatment
Change between baseline and over 4-week treatment phase in daytime sleepiness symptoms severity as measured with the Epworth Sleepiness Scale (ESS)
Time frame: From baseline to the end of the treatment after 4 weeks
Change between baseline and over 4-week treatment phase in Profile of Mood states as measured with the POMS-2 questionnaire (POMS-2).
Time frame: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in state anxiety as measured with the State-Trait-Anxiety-Inventory (STAI-Y1 & Y2).
Time frame: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in anxiety disorders as per the assessment of the clinician on the HAM-A scale (HAM-A).
Time frame: Change between baseline and over 4-week treatment phase
Change between baseline and over 4-week treatment phase in psychological well-being as measured with the Depression, Anxiety, and Stress Scale (DASS-21).
Time frame: Change between baseline and over 4-week treatment phase
Subjective efficacy
Time frame: Day 36
Acceptance of the treatment
Time frame: On day 36
Subjective tolerability
Time frame: On Day 36
Change between baseline and over 4-week treatment phase in physiological sleep quantity and quality and physiological measures via actigraphy (wearable).
Time frame: Change between baseline and over 4-week treatment phase
Rate/kind of adverse events
Time frame: on day 36
Blood pressure
Time frame: Change between baseline and day 36
Blood pulse
Time frame: Change between baseline and day 36
Change in Blood safety parameters
Time frame: Change between baseline and day 36
Rate/kind of comedication
Time frame: Change between baseline and day 36
Treatment compliance
Time frame: on day 36
Change in biomarker for stress between baseline and over 4-week treatment phase via the salivary evening cortisol levels (8 p.m.)
Time frame: Change from baseline days 6/7 to chronic treatment after days 34/35
Change in biomarker for sleep readiness between baseline and over 4-week treatment phase via the salivary evening melatonin level (8 p.m.)
Time frame: Change from baseline days 6/7 to chronic treatment by days 34/35
Change between baseline and over 4-week treatment phase in ratio of biomarker evening melatonin level/ evening cortisol level (8 p.m.)
Time frame: Change from baseline days 6/7 to chronic treatment by days 34/35
Change between baseline and over 4-week treatment phase in biomarker for chronic stress via the CAR determined
Time frame: Change from baseline days 6/7 to chronic treatment by days 34/35
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided. IPD may be sharaable upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eschscholzia tablets in people with Sleep, run by A. Vogel AG at 1 site in Bulgaria.
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 11 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 6 Apr 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 Bulgaria. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline over the 4-week treatment phase in perceived sleep quality, as measured by the summed area under the curve (summed up ISI AUC) of the Insomnia Severity Index (ISI) Total Score. (time frame: Change between baseline and over 4-week treatment phase). The study lists 2 primary outcomes in all. 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 6 Apr 2026.