Efficacy study on a food supplement based on melatonin, Withania somnifera (L.) Dunal, L-ornithine, magnesium and Crocus sativus L. for sleep management: single-centre, placebo-controlled, randomized, double-blind cross-over, clinical study with a period of run-in

ANTUR S.r.l0 个研究点目标入组 66 人开始时间: 2024年3月4日最近更新: 2024年3月18日

适应症

试验速览

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•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

•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

发起方

ANTUR S.r.l