NCT05459272

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

A Randomized, Placebo-Controlled Clinical Trial on a Dietary Supplement Containing Melatonin and Herbal Products to Improve Sleep Quality in Subjects With Insomnia Problems

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Uriach Consumer Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Aquilea Sueno Forte	The test product consists of a dietary supplement in the form of tablets with three layers containing: melatonin (1.95 mg/tablet) and herbal products (extracts from Griffonia, Passiflora, California poppy, Valerian, Melissa). Patients should take one tablet daily 30 min before go to bed during 7 days (from day 7 to day 14).
OTHER	Placebo	The placebo will consist of tablets with three layers and with the same appearance as the dietary supplement under study, but containing no active ingredients. Patients should take one tablet daily 30 min before go to bed during 7 days (from day 7 to day 14).

Timeline

• Start date: 2022-07-10
• Primary completion: 2023-09-30
• Completion: 2023-10-30
• First posted: 2022-07-14
• Last updated: 2023-08-31

Locations

1 site across 1 country: Spain