Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality
NCT ID: NCT05459272
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-07-10
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of a Novel Melatonin Supplement on Sleep Quality
NCT06215573
Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia
NCT02798367
Effects of Melatonin on Insomnia Symptoms in Older Adults
NCT00230737
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
NCT05368909
Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)
NCT03951025
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Once the informed consent is signed, the patient will be assigned a patient code. The study treatment will be provided in white boxes with trial and patient identification labels, which will be identical for both products (dietary supplement and placebo), and the administration regimen will be the same for both products, thereby maintaining the double blind.
Treatment intake will begin on study day 7 and end on day 14.
The investigator will have an encrypted randomization list, so that, if necessary, he/she can determine the treatment group assigned to a patient.
Treatment compliance will be recorded by the investigator at the 14-day visit.
No other pharmacological or non-pharmacological treatment for insomnia will be allowed during the study.
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Aquilea Sueño Forte
Patients included in this group will be administered dietary supplement with melatonin and herbal products, one tablet daily 30 min before to go to bed during 7 days (from day 7 to day 14).
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).
Control
The control will consist of a placebo based on excipients without active ingredients so that the tablet has the same appearance as the test product.
Patients should take one tablet daily 30 min before to go to bed during 7 days (from day 7 to day 14).
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Uriach Consumer Healthcare
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jesús Escribá, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto de Medicina del Sueño
Alboraya, Valencia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
URI-AQ-SUEFORT-2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.