NCT07085819
Recruiting
Not Applicable
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
Kerry Group P.L.C1 site in 1 country160 target enrollmentStarted: July 15, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kerry Group P.L.C
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Sleep restorative quality
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •TSH values between 0.27 - 4.20 miU/L
- •Is in general good health, as determined by the investigator.
- •Willing to consume the Study Product daily for the duration of the study.
Exclusion Criteria
- •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- •Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- •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.
- •Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
- •Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- •Has a score ≥10 on Patient Health Questionnaire 8 item (PHQ-8)
- •Has a score ≥10 on Athens Insomnia Scale (AIS)
- •Participants at a high risk of sleep apnoea as determined by Berlin questionnaire/Score \>5 for sleep apnoea.
Outcomes
Primary Outcomes
Sleep restorative quality
Time Frame: 8 weeks
To evaluate the impact of 8 weeks daily supplementation of the Botanical Extract on Non-Restorative Sleep (NRS) as assessed by Restorative Sleep Questionnaire (RSQ-W) score compared to placebo. The total score range from 0-100 with higher scores indicating better restorative sleep.
Secondary Outcomes
- Sleep Quality(8 weeks)
- Attention-Rapid Visual Information Processing (RVIP)(8 weeks)
- Attention-Sustained Attention to Response Task (SART).(8 weeks)
- Cognition(8 weeks)
- Stress(8 weeks)
- Sleep parameters-Total Sleep Time (TST)(24-hour wear time for 8 weeks)
- Sleep Parameters- Wake After Sleep Onset (WASO)(24-hour wear time for 8 weeks)
- Sleep Parameters- Sleep Onset Latency (SOL)(24-hour wear time for 8 weeks.)
- Sleep Parameters- Sleep Efficiency (SE)(24-hour wear time for 8 weeks)
Investigators
Study Sites (1)
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