Study of Ashwagandha Extract to Improve Sleep Quality in Adults with Non-Restorative Sleep

What this Trial Is About

Researchers are evaluating the effect of a Botanical Extract on improving symptoms of nonrestorative sleep NRS in healthy adults aged 18 to 65. The main question is whether this Botanical Extract can enhance sleep quality and reduce symptoms of NRS compared to a placebo. The study is a prospective, randomized, double-blind, placebo-controlled trial sponsored by Kerry Group P.L.C. Participants will be randomly assigned to take one of three doses of the Botanical Extract 125 mg, 250 mg, or 500 mg per day or a placebo daily for 8 weeks. Each dose is given as two capsules before sleep, with or without food. The study includes four clinic visits for checkups and tests, along with three follow-up phone calls during the trial period. During the trial, participants will be monitored for sleep restorative quality as the primary outcome after 8 weeks. Secondary outcomes include overall sleep quality, attention and cognition tests, stress levels, and detailed sleep parameters such as total sleep time, wake time after sleep onset, sleep onset latency, and sleep efficiency using 24-hour wear-time monitoring. Safety and adherence will be assessed through regular visits and phone calls, with total participation lasting 8 weeks.

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