Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750681
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-01-28
Brief Title:
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Sponsor:
Comercial Quimica Masso SA
Organization:
Comercial Quimica Masso SA
Study Overview
Official Title:
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Status:
COMPLETED
Status Verified Date:
2021-01
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:
Therefore the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract Saffractiv on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety
Detailed Description:
This study has been designed as a randomized double-blind placebo-controlled interventional study
Sixty-six subjects were randomly allocated to the control placebo or test Saffractiv group
A screening visit was scheduled within 4 weeks before Day -7 study inclusion At Day -7 and Day 0 questionnaires were completed to evaluate sleep quality stress level and quality of life Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered Then subjects were supplemented during 6 weeks with the placebo or saffron Saffractiv product depending on their group Following the baseline period two other periods of one week were scheduled to collect actigraphy data between 2 and 3 from Day 14 to Day 21 weeks and between 5 and 6 from Day 35 to Day 42 weeks after the beginning of the intervention At the middle Day 21 and at the end of the study Day 42 questionnaires were completed to evaluate sleep quality stress level andor quality of life
Sixty-six subjects were randomly allocated to the control placebo or test Saffractiv group
A screening visit was scheduled within 4 weeks before Day -7 study inclusion At Day -7 and Day 0 questionnaires were completed to evaluate sleep quality stress level and quality of life Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered Then subjects were supplemented during 6 weeks with the placebo or saffron Saffractiv product depending on their group Following the baseline period two other periods of one week were scheduled to collect actigraphy data between 2 and 3 from Day 14 to Day 21 weeks and between 5 and 6 from Day 35 to Day 42 weeks after the beginning of the intervention At the middle Day 21 and at the end of the study Day 42 questionnaires were completed to evaluate sleep quality stress level andor quality of life
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