Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154629
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2023-11-23
Brief Title:
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Sponsor:
Universidad Católica San Antonio de Murcia
Organization:
Universidad Católica San Antonio de Murcia
Study Overview
Official Title:
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Q-Sleep
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None