The beneficial effect on sleep of a food supplement based on Scutellaria lateriflora L. (aerial parts of the plant)

Not Applicable

• Conditions: Subjects with mild to moderate primary insomnia; Mental and Behavioural Disorders

• Registration Number: ISRCTN12126820
• Lead Sponsor: Epo S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Last Update Posted: 24 June 2024
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 66

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

1.Aged < 18 and > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)]