NCT07085819

Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)

A Prospective, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effects Of Ashwagandha (Withania Somnifera,Ws) Root Plus Leaf Aqueous Extract On Quality Of Sleep In Subjects With Non-Restorative

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Kerry Group P.L.C · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the effect of the Botanical Extract in improving sleep symptoms of nonrestorative sleep (NRS) in healthy adults. The main question it aims to answer is • Does the Botanical Extract improve sleep quality and reduce symptoms of nonrestorative sleep (NRS)? Researchers will compare the Botanical Extract to a placebo to see if it works. Participants will: * Take one of 3 doses of the Botanical Extract (125 mg/day, 250mg/day ,500mg/day) or a placebo every day for 8 weeks. * Visit the clinic four times for checkups and tests and receive three follow-up phone calls.

Conditions

• Non Restorative Sleep
• Sleep Disorder (Disorder)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Botanical Extract, 125mg	Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.
DIETARY_SUPPLEMENT	Botanical Extract, 250mg	Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.
DIETARY_SUPPLEMENT	Botanical Extract, 500mg	Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks
DIETARY_SUPPLEMENT	Pacebo	Two capsules per day before sleep, with or without food, for 8 weeks.

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-07-25
• Last updated: 2025-08-26

Locations

1 site across 1 country: Ireland