Subjects with mild to moderate primary insomnia Mental and Behavioural Disorders
Conditions
Interventions
The subjects recruited in the present clinical study will consume, a food supplement based on Scutellaria lateriflora L. (aerial parts of the plant) in capsules at 400 mg/day dose, and a placebo, in a
Sponsors
Epo S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 - 70 years of both sexes 2. Subjects able to understand and sign the informed consent 3. With primary insomnia, present for at least one month 4. With ISI questionnaire scores <22 5. With GAD-7 questionnaire scores <5 6. With PHQ-9 questionnaire scores <5
Exclusion criteria
Exclusion criteria: 1. Aged 70 years 2. Pregnant or breastfeeding individuals 3. Subjects with secondary insomnia or other sleep disorders, such as obstructive sleep apnea, narcolepsy, nocturnal myoclonus, restless legs syndrome, advanced sleep phase disorder, delayed sleep phase disorder, paradoxical insomnia, parasomnias 4. Subjects with ISI questionnaire scores >22 5. Subjects with GAD-7 questionnaire scores >5 6. Subjects with PHQ-9 questionnaire scores >5 7. Subjects suffering from psychiatric disorders: major depression, generalized anxiety disorder, post-traumatic stress disorder, panic attacks, bipolar disorder, dementia, schizophrenia 8. Subjects with chronic and acute pain conditions (e.g., arthritis, fibromyalgia, back pain, headaches, respiratory diseases, asthma, diabetes, heart diseases, injuries, hyperthyroidism, gastroesophageal reflux, epilepsy, Parkinson's disease, Alzheimer's disease, kidney diseases) 9. Subjects who abuse alcohol, amphetamines, caffeine, theine 10. Subjects taking antidepressants, diuretics 11. Subjects with hypothyroidism 12. Subjects who have taken monoamine oxidase inhibitors in the 14 days prior to recruitment 13. Subjects taking antibiotics or who have taken antibiotics in the last four weeks, or in the last 6 months, based on the intensity and duration of antibiotic treatment 14. Subjects with cognitive disorders that may hinder the response to questionnaires 15. Subjects with known allergy to the ingredients of the experimental products (active - placebo) 16. Subjects with acquired immunodeficiency syndrome from HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality: Pittsburgh Sleep Quality Index (PSQI) [Time frame: tr (run-in start), t0 (baseline), t1 (after 28 days of the first treatment period), t2 (after 56 days of the first treatment period), t3 (baseline of the second treatment period), t4 (after 28 days of the second treatment period), t4 (after 56 days of the second treatment period)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the following parameters of the sleep-wake cycle using The Integrated Sleep Diary completed daily for the entire duration of the study, starting from the beginning of the run-in period until the last day of the second treatment period: 1. Total Time in Bed (TTL) = the time interval in minutes between when the patient goes to bed and when they get up from bed; 2. Sleep Onset Latency (SOL) = the time interval (in minutes) between when the patient goes to bed (turns off the lights or TV) and when they fall asleep; 3. Number of Awakenings (NR) = the number of nighttime awakenings; 4. Duration of nocturnal awakenings (WASO - wakefulness after sleep onset) = intranight wakefulness given by the total sum of wakefulness (in minutes) during nighttime awakenings; 5. Total Sleep Time (TTS) = the time interval (in minutes) between when the patient falls asleep and when they wake up definitively in the morning minus intranight wakefulness; 6. Sleep Efficiency Index (IES) = TTS/TTL*100. 7. Evaluation of the possible presence of pain or discomfort that could affect sleep quality using the Visual Analogue Scale (VAS). [Time frame: tr (run-in start), t0 (baseline), t1 (after 28 days of the first treatment period), t2 (after 56 days of the first treatment period), t3 (baseline of the second treatment period), t4 (after 28 days of the second treatment period), t4 (after 56 days of the second treatment period)]. | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed