NCT05971771

Study to Assess Impact of Dietary Supplement on Sleep Health

A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.

Conditions

• Sleep

Interventions

Type	Name	Description
OTHER	Placebo	Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed
DIETARY_SUPPLEMENT	Treatment	14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-08-30
• Completion: 2023-12-31
• First posted: 2023-08-02
• Last updated: 2023-08-02