Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04812418
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep disorder severity', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of Insomnia Severity Index (ISI) score'}], 'secondaryOutcomes': [{'measure': 'Sleep disorder severity over time', 'timeFrame': 'Baseline and D49 (end of follow-up)', 'description': 'Change from baseline of Insomnia Severity Index (ISI) score'}, {'measure': 'Investigator assessment of sleep disorder symptoms severity', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of Clinical Global Impression Severity (CGI-S) score'}, {'measure': 'Investigator assessment of sleep disorder symptoms improvement', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of Clinical Global Impression Improvement (CGI-I) score'}, {'measure': 'Patient assessment of sleep disorder symptoms improvement after intervention', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of Patient Global Impression Improvement (PGI-I) score'}, {'measure': 'Anxiety status', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of Hamilton anxiety rating scale (HAM-A) score'}, {'measure': 'Anxiety status over time', 'timeFrame': 'Baseline and D49 (end of follow-up)', 'description': 'Change from baseline of Hamilton anxiety rating scale (HAM-A) score'}, {'measure': 'Short-form 36 questionnaire (SF36)', 'timeFrame': 'Baseline and D28 (end of supplementation)', 'description': 'Change from baseline of SF36 scores'}, {'measure': 'Actimeters', 'timeFrame': 'Baseline, D7, D14, D21 and D28 (end of supplementation)', 'description': 'Change from baseline of the mean values obtained from actimeters recording during the 7 days'}, {'measure': 'Electronic sleep diaries', 'timeFrame': 'Baseline, D7, D14, D21 and D28 (end of supplementation)', 'description': 'Change from baseline of the mean values obtained from electronic sleep diaries during the 7 days'}, {'measure': 'Evolution of sleep troubles', 'timeFrame': 'Baseline, D28 (end of supplementation) and D49 (end of follow-up)', 'description': 'Change from baseline of sleep troubles regarding changes in medical prescriptions, reason of changes and number of intercurrent medical visits for sleep disorders'}, {'measure': 'Addiction', 'timeFrame': 'Baseline and D49 (end of follow-up)', 'description': 'Change from baseline of Addiction questionnaire scores'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)', 'description': 'Incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Troubles Associated With Anxiety']}, 'descriptionModule': {'briefSummary': '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 supplementation, in subjects suffering from sleep troubles associated with anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Woman or man, aged of 18 to 65 years;\n* In good general health as evidenced by medical history and physical examination;\n* Having at least 3 episodes of sleep disorders per week including one or more of the following:\n\n 1. difficulty falling asleep or\n 2. difficulty staying asleep or\n 3. poor quality sleep\n 4. Waking up earlier than desired\n* The insufficient sleep duration and quality is coupled with a feeling of general fatigue;\n* Sleep disorder last for more than 1 month;\n* Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);\n* With anxiety resulting in a HAM-A score \\> 8 and \\< 25;\n* 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):\n\n 1. Negative blood pregnancy test\n 2. Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;\n* Fluent French speaking;\n* Provision of signed and dated informed consent form;\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* A score \\> 10 on the ESS scale (that would correspond to serious hypersomnia);\n* 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,… );\n* 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, …);\n* Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, …);\n* Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;\n* Subjects with pre-menstrual syndrome or myasthenia gravis;\n* 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);\n* Smoker;\n* Subject consuming drugs and/or with historical drug addiction;\n* 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, .…);\n* Volunteer with suicidal risk according to the investigator;\n* Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;\n* Volunteer presenting current infection and/or fever;\n* Volunteer with medical history of stroke or head trauma;\n* Pregnant or lactating woman;\n* Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);\n* Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;\n* 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;\n* Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, …);\n* Pharmacological resistance to common hypnotic/sedative drugs;\n* Allergy/intolerance to the actimeter straps;\n* Recent (\\< 1 month before the inclusion) change in lifestyle (food, body weight \\> 5kg, sport)."}, 'identificationModule': {'nctId': 'NCT04812418', 'briefTitle': 'Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Larena SAS'}, 'officialTitle': 'Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo', 'orgStudyIdInfo': {'id': 'Pil-Clin-Noct-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': '120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days', 'interventionNames': ['Dietary Supplement: Noctesia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group (B)', 'description': 'Placebo 28 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Noctesia', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 tablets every day at bedtime with a large glass of water', 'armGroupLabels': ['Group (A)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 tablets every day at bedtime with a large glass of water', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1348', 'city': 'Louvain-la-Neuve', 'country': 'Belgium', 'facility': "Centre d'Investigation Clinique en Nutrition", 'geoPoint': {'lat': 50.66829, 'lon': 4.61443}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PiLeJe', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}