Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900024
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-06-02
Brief Title:
A Study to Evaluate the Effect of Funk It Cycle Bites on PMS
Sponsor:
Funk It Wellness
Organization:
Funk It Wellness
Study Overview
Official Title:
An Open-Label Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
This is a virtual open-label single-group study that will last 4 menstrual cycles All participants will complete a questionnaire at the end of their first period after enrolling baselinenon-intervention cycle 1 then proceed to take the product daily and complete questionnaires at the end of their next 3 periods intervention cycles 1 2 and 3 The study will involve 30 female participants with regular menstrual cycles who experience PMS
Questionnaires will be used to monitor menstrual paincramps energy levels mood and hormonal acne experienced before and during the menstrual cycle Likert scale responses will be statistically compared from baseline to each check-in Participant responses on product feedback will be presented as scores
Questionnaires will be used to monitor menstrual paincramps energy levels mood and hormonal acne experienced before and during the menstrual cycle Likert scale responses will be statistically compared from baseline to each check-in Participant responses on product feedback will be presented as scores
Detailed Description:
None
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