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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05128812
Other study ID # UA-2021-03-26
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2022

Study information

Verified date June 2023
Source University of Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a Spanish adult population.


Description:

Anxiety is a normal part of life, and generally is a temporary condition. However, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. There are a number of synthetic drugs that are commonly used to treat anxiety. These are mainly antidepressants and benzodiazepines. However, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. To this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. Of note is lemon verbena (Lippia citriodora), which is native of Western South America but is also cultivated in the Mediterranean region and Middle East.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2022
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. Over 21 years of age; 2. Without any chronic pathology; 3. Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety); 4. Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality). Exclusion Criteria: - Failure to meet the inclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PLX
Intake of natural food supplement of vegetable origin based on lemon verbena extract (Lippia citriodora). To study the anxiolytic effects in subjects with high perceived stress levels and low sleep quality.

Locations

Country Name City State
Spain University of Alicante Alicante

Sponsors (1)

Lead Sponsor Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary WEIGHT The weight of the subjects will be obtained using the TANITA (Tokyo, Japan). 3 months
Primary HEIGHT The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany). 3 months
Primary BLOOD PREASURE Measurement of blood pressure (systolic and diastolic) with a digital tensiometer. 3 months
Primary FAT MASS Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass. 3 months
Primary VISCERAL FAT Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat. 3 months
Primary BLOOD CORTISOL Cortisol levels in blood by blood analysis. 3 months
Primary SLEEP QUALITY Measurement of sleep quality using the Pittsburgh sleep quality index. 3 months
Primary STRESS Measurement of perceived stress using the Perceived Stress Scale (PSS). 3 months
Primary ANXIETY Measurement of perceived anxiety using the Spielberger Trait-State Anxiety Inventory questionnaire; it is an instrument created with the objective of assessing anxiety in two dimensions, state and trait. 3 months
Primary PERCEIVED QUALITY OF LIFE Measurement of quality of life using the World Health Organization Quality of Life (WHOQOL-BREF). The WHOQOL-BREF instrument provides a profile of quality of life, with each dimension or domain being scored independently. each dimension or domain scored independently. The higher the higher the score in each domain, the better the quality of life profile of the person being the person being assessed. 3 months
Primary HEART RATE An electrocardiogram is used to obtain the heart rate. 3 months
Primary SLEEP HOURS Use of a FITBIT device to monitor the hours of sleep of each participant. 3 months
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