Sleep Disorders Clinical Trial
Official title:
A Randomized, Placebo-Controlled Clinical Trial on a Dietary Supplement Containing Melatonin and Herbal Products to Improve Sleep Quality in Subjects With Insomnia Problems
A randomized, double-blind, placebo-controlled clinical trial on the ability of a dietary supplement containing melatonin and herbal products to improve sleep quality in subjects with insomnia problems with a 15-day follow-up period.
This is a single-centre clinical trial on a dietary supplement with a 15-day follow-up period. The investigators will include patients of legal age with DSM-5 diagnostic criteria for insomnia, without other sleep disorders. The study will begin at baseline visit (day 0), when the inclusion and exclusion criteria will be confirmed and patient will sign the informed consent form. Information related to sleeping disorder will be collected and actigraphy device will be delivered to the patient. Patient will wear the device during 14 days. After 7 days of wearing the device, patient will return to the follow-up visit (visit 1). The actigraph data will be downloaded and the treatment will be dispensed to the patient. Regimen will consist of taking one tablet per day of the product (dietary supplement or placebo) 30 minutes before bedtime during the following 7 days and will continue to wear the device. At day 15 (final visit) patient will return the actigraph and clinical and safety data will be collected. ;
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