Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKerry Group P.L.C
About this trial
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 criteria
Qualifiers
Be able to give written informed consent.
Be between 18 and 65 years, inclusive.
Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over a one-month period.
Have a RSQ-W total score of ≤50 at screening.
Disqualifiers
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
Sexual partner(s) is/are exclusively female.
Trial design
Treatments tested in this trial
- Botanical Extract, 125mg
- Botanical Extract, 250mg
- Botanical Extract, 500mg
- Pacebo
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Kerry Group P.L.C
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov