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

NCT07085819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Non Restorative Sleep
  • Sleep Disorder (Disorder)

Interventions

DIETARY_SUPPLEMENT

Botanical Extract, 125mg

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

DIETARY_SUPPLEMENT

Botanical Extract, 250mg

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

DIETARY_SUPPLEMENT

Botanical Extract, 500mg

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

DIETARY_SUPPLEMENT

Pacebo

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

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Kerry Group P.L.C

    lead INDUSTRY

Principal Investigators

  • Timothy Dinan · Atlantia Clinical Trials LTD.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085819 on ClinicalTrials.gov