Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality

Launched by URIACH CONSUMER HEALTHCARE · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a dietary supplement that includes melatonin and herbal products to see if it can help improve sleep quality for people with insomnia. Insomnia can make it hard to fall asleep, stay asleep, or wake up too early. The trial is looking for participants aged 65 to 74 who have been diagnosed with insomnia and have not used any sleep medications or supplements in the past week.

If you decide to participate, you will be part of a study that lasts for 15 days, where some people will receive the actual supplement and others will receive a placebo, which looks the same but has no active ingredients. You will be asked to complete a small questionnaire about your sleep to help assess your condition. It’s important to note that pregnant or nursing women, people with certain sleep disorders, or those with serious health issues may not qualify for this trial. Your participation will help researchers understand if this supplement can be an effective way to improve sleep for those struggling with insomnia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of legal age with DSM-5(\*) diagnostic criteria for insomnia assessed from the Sleep Test responses (ST: 5-item questionnaire modified from the "Oviedo Sleep Questionnaire").
• • Patients with insomnia of the following types: sleep onset insomnia (\> 30 minutes of sleep latency), maintenance insomnia (frequent awakenings or inability to fall asleep after awakening) or mixed insomnia
• • Patients who are not on treatment or have not taken any dietary supplements or hypnotics for insomnia, or any other psychoactive drug in the past week.
• • Patients able to understand the implications of the study and who demonstrate this by voluntarily signing the informed consent
• DSM-5 diagnostic criterion for insomnia:
• A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
• • 1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
• • 2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)
• • 3. Early-morning awakening with inability to return to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
• • C. The sleep difficulty occurs at least 3 nights per week. D. The sleep difficulty is present for at least 3 months. E. The sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
• • G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
• • H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
• Exclusion Criteria:
• • Pregnant or nursing women
• • Patients with other sleep disorders: narcolepsy, obstructive apnea, circadian rhythm disorder, parasomnias
• • Patients with active psychiatric disorders or cognitive impairment
• • Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or disadvise their participation in it
• • Patients who do not give their written consent
• • Patients with known hypersensitivity or intolerance to any of the active ingredients or components of the dietary supplement or placebo.