The beneficial effect on sleep function of a food supplement based on melatonin, Withania somnifera (L.) Dunal, L-ornithine, magnesium and Crocus sativus L.

Not Applicable

Completed

• Conditions: Primary insomnia; Mental and Behavioural Disorders

• Registration Number: ISRCTN17704876
• Lead Sponsor: ANTUR S.r.l

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-30
• Study Start: 2024-03-04
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects aged 18-65 years of both sexes
2. Subjects able to understand and sign the informed consent
3. Subjects who have a score between 5 and 7 in the Patient Health Questionnaire-9 (PHQ-9), corresponding to subjects with slightly altered mood, not frankly pathological, whose score in the Patient Health Questionnaire-9 is lower than the maximum limits of subthreshold depression (which has a score of 9 in the PHQ-9)
4. Subjects who present a mild mood alteration (subthreshold depression) (Patient Health Questionnaire-9 between 5 and 7) and who are not eligible to take antidepressant drugs
5. Subjects who do not present anxiety and who have a GAD-7 score =7

Exclusion Criteria

1. Aged <18 and >75 years
2. A medical history or condition that could affect the subject's safety or negatively impact the validity of the study results
3. Pregnant or breastfeeding women
4. A history of allergy to ingredients contained in the study treatments (dietary supplement and placebo)
5. Exposed to a high risk of cardiovascular events based on eight risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, HDL-cholesterolemia, and antihypertensive treatment)
6. Following drug therapy for diabetes even at low dosages
7. Taking supplements to control cholesterol, blood sugar, and metabolic syndrome, in the 2 weeks prior to recruitment
8. Women who are suspected to be pregnant or are planning pregnancy
9. Non-self-sufficient individuals
10. Do not show a propensity to collaborate
11. Have difficulty getting to the reference facility within the scheduled time
12. Are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep-wake balance assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire at the start and the end of each study period