Study of the Effects of Plx on Bioparametric Measurements.

University of Alicante

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Antidepressive Agents; Quality of Life; Depression, Anxiety; Stress, Psychological; Body Composition

Treatments: Dietary Supplement: PLX

Study type: Interventional

Funder types: Other

Identifiers

NCT05128812

UA-2021-03-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

CONTROL GROUP

Placebo Comparator group

Description:

Nutraceutical placebo intake group

Treatment:

Dietary Supplement: PLX

PLX400mg GROUP

Experimental group

Description:

Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).

Treatment:

Dietary Supplement: PLX