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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A) | Experimental | 120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days |
|
| Group (B) | Placebo Comparator | Placebo 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noctesia | Dietary Supplement | 3 tablets every day at bedtime with a large glass of water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep disorder severity | Change from baseline of Insomnia Severity Index (ISI) score | Baseline and D28 (end of supplementation) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep disorder severity over time | Change from baseline of Insomnia Severity Index (ISI) score | Baseline and D49 (end of follow-up) |
| Investigator assessment of sleep disorder symptoms severity |
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Inclusion Criteria:
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:
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):
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 Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique en Nutrition | Louvain-la-Neuve | B-1348 | Belgium |
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| Placebo |
| Dietary Supplement |
3 tablets every day at bedtime with a large glass of water |
|
Change from baseline of Clinical Global Impression Severity (CGI-S) score
| Baseline and D28 (end of supplementation) |
| Investigator assessment of sleep disorder symptoms improvement | Change from baseline of Clinical Global Impression Improvement (CGI-I) score | Baseline and D28 (end of supplementation) |
| Patient assessment of sleep disorder symptoms improvement after intervention | Change from baseline of Patient Global Impression Improvement (PGI-I) score | Baseline and D28 (end of supplementation) |
| Anxiety status | Change from baseline of Hamilton anxiety rating scale (HAM-A) score | Baseline and D28 (end of supplementation) |
| Anxiety status over time | Change from baseline of Hamilton anxiety rating scale (HAM-A) score | Baseline and D49 (end of follow-up) |
| Short-form 36 questionnaire (SF36) | Change from baseline of SF36 scores | Baseline and D28 (end of supplementation) |
| Actimeters | Change from baseline of the mean values obtained from actimeters recording during the 7 days | Baseline, D7, D14, D21 and D28 (end of supplementation) |
| Electronic sleep diaries | Change from baseline of the mean values obtained from electronic sleep diaries during the 7 days | Baseline, D7, D14, D21 and D28 (end of supplementation) |
| Evolution of sleep troubles | Change from baseline of sleep troubles regarding changes in medical prescriptions, reason of changes and number of intercurrent medical visits for sleep disorders | Baseline, D28 (end of supplementation) and D49 (end of follow-up) |
| Addiction | Change from baseline of Addiction questionnaire scores | Baseline and D49 (end of follow-up) |
| Adverse events | Incidence of adverse events | Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up) |