Last reviewed · How we verify
NCT07085819
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
NA trial testing Botanical Extract, 125mg in Non Restorative Sleep in 160 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Kerry Group P.L.C |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 160 |
| Start date | 15 July 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- Botanical Extract, 125mg
- Botanical Extract, 250mg
- Botanical Extract, 500mg
- Pacebo — full drug profile →
Conditions studied
- Non Restorative Sleep — all drugs for Non Restorative Sleep →
- Sleep Disorder (Disorder) — all drugs for Sleep Disorder (Disorder) →
Sponsor
Kerry Group P.L.C
Who can join
Adults 18 to 65, any sex, with Non Restorative Sleep or Sleep Disorder (Disorder). Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07085819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Kerry Group P.L.C trials
Trials by the same sponsor.
- NCT06308146 — Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functio · NA · completed
- NCT06644001 — Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults. · NA · completed
- NCT06641596 — Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07085819 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kerry Group P.L.C
- Last refreshed: 25 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07085819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing