RecruitingNot ApplicableNCT07085819

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


Sponsor

Kerry Group P.L.C

Enrollment

160 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Botanical Extract, 125mg, Botanical Extract, 250mg, and others for people with non-restorative sleep and sleep disorder (disorder). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTBotanical Extract, 125mg

Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.

DIETARY_SUPPLEMENTBotanical Extract, 250mg

Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.

DIETARY_SUPPLEMENTBotanical Extract, 500mg

Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks

DIETARY_SUPPLEMENTPacebo

Two capsules per day before sleep, with or without food, for 8 weeks.


Locations(1)

Atlantia Food Clinical Trials Ltd.

Cork, Ireland

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NCT07085819


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