NCT06154629

Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Universidad Católica San Antonio de Murcia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Randomized, controlled, double-blind, single-center clinical trial with two parallel arms depending on the product consumed (experimental product and placebo product) to analyze the efficacy of a botanical extract in reducing anxiety and improving sleep quality.

Detailed description

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned). The product to be consumed is a botanical extract. Participants will consume the product for 90 days. They should consume one capsule one hour before going to sleep. They will make a total of five visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Conditions

• Poor Quality Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Botanical ingredient	Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
DIETARY_SUPPLEMENT	Control group	Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-12-22
• Completion: 2024-01-29
• First posted: 2023-12-04
• Last updated: 2024-02-16

Locations

1 site across 1 country: Spain