Status:
COMPLETED
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Lead Sponsor:
PiLeJe
Collaborating Sponsors:
Université Catholique de Louvain
Conditions:
Sleep Troubles Associated With Anxiety
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this double-blind randomized clinical trial is to compare the effects of a dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of supplementatio...
Eligibility Criteria
Inclusion
- Woman or man, aged of 18 to 65 years;
- In good general health as evidenced by medical history and physical examination;
- Having at least 3 episodes of sleep disorders per week including one or more of the following:
- difficulty falling asleep or
- difficulty staying asleep or
- poor quality sleep
- Waking up earlier than desired
- The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
- Sleep disorder last for more than 1 month;
- Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);
- With anxiety resulting in a HAM-A score \> 8 and \< 25;
- For women of childbearing age (women of childbearing potential, pre-menopausal or having postmenopausal amenorrhea of less than 12 months, and women who have not undergone surgical sterilization):
- Negative blood pregnancy test
- Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;
- Fluent French speaking;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion
- A score \> 10 on the ESS scale (that would correspond to serious hypersomnia);
- Sleep disorders secondary to another health problem (sleep apnea syndrome, narcolepsy-cataplexy, idiopathic hypersomnia, restless legs syndrome, chronic pain syndrome, ...) or an environmental factor (noise, light ...) or socio-professional (shift work, young child at home, people who are often jet lagged,… );
- Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,…) or a severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, …);
- Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, …);
- Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;
- Subjects with pre-menstrual syndrome or myasthenia gravis;
- Subjects who drink more than 2 glasses of alcohol per day (\> 20g of alcohol per day) or with exaggerated consumption of theine (≥ 1l per day) and caffeine-rich (≥ 800ml per day) beverages and energy drink (≥ 330ml per day);
- Smoker;
- Subject consuming drugs and/or with historical drug addiction;
- Under psychotropic treatment within the last month before screening (neuroleptic, anxiolytic, antidepressant, hypnotic, sedative, …) or under current medication treatment which may alter the waking state (for example: cortisone, dopamine, amphetamine, antihistamines, beta-blockers, certain cough syrups, .…);
- Volunteer with suicidal risk according to the investigator;
- Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;
- Volunteer presenting current infection and/or fever;
- Volunteer with medical history of stroke or head trauma;
- Pregnant or lactating woman;
- Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);
- Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;
- Subjects that present alterations of their cognitive functions that will interfere with the comprehension of the study and procedures and/or with the completion of questionnaires;
- Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, …);
- Pharmacological resistance to common hypnotic/sedative drugs;
- Allergy/intolerance to the actimeter straps;
- Recent (\< 1 month before the inclusion) change in lifestyle (food, body weight \> 5kg, sport).
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04812418
Start Date
March 29 2021
End Date
June 9 2023
Last Update
November 13 2023
Active Locations (1)
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1
Centre d'Investigation Clinique en Nutrition
Louvain-la-Neuve, Belgium, B-1348