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Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Stress Clinical Trial

Official title:
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Clinical Trial Summary

Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.

Clinical Trial 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 (Saffr'activ®) 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 (Saffr'activ®) 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 and/or quality of life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04750681
Study type Interventional
Source Comercial Quimica Masso, S.A
Contact
Status Completed
Phase N/A
Start date August 12, 2019
Completion date November 3, 2020
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