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

NCT05459272 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-31

No results posted yet for this study

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.

Conditions

  • Sleep Disorders

Interventions

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).

Sponsors & Collaborators

  • Uriach Consumer Healthcare

    lead INDUSTRY

Principal Investigators

  • Jesús Escribá, PhD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-10
Primary Completion
2023-09-30
Completion
2023-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05459272 on ClinicalTrials.gov