The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality

The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality as Compared to a Melatonin Control: A Randomized, Double-Blinded, Controlled Clinical Trial

The purpose of this study is to evaluate the efficacy and superiority of a botanical based sleep product on sleep quality as compared to melatonin, among healthy female participants.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Proprietary Blend of Botanical Extracts; Dietary supplement: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Nutraceuticals Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Provision of signed and dated informed consent form Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study Self reported poor sleep quality Biological sex of woman; gender identification of female Aged 35 to 55, inclusive Good general health as evidenced by medical history and screening For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study Has an apple watch or similar device Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

Pregnancy, trying to conceive, or breastfeeding Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year Has received medical diagnosis or treatment for any sleep disorder in the past year Has ever received a medical diagnosis of sleep apnea or narcolepsy Works a night shift, is "on-call" or performs any job requiring or potentially requiring work related responsibilities after 8pm Consumes > 8 alcoholic beverages in an average week Is a primary caretaker for a child younger than 18 months of age Consumes any sleep aid, medication, diet, or supplement intended to improve sleep in any way Known allergic reactions to any components of the intervention Positive COVID-19 test within 30 days of the study period Recent dramatic weight changes (10% change in body weight in the last 6 months) Introducing a new investigational drug or other intervention within 60 days before the start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparison	Dietary supplement: Melatonin; Participants consumed 1mg melatonin each night before bed.
Experimental: Botanical Blend	Dietary supplement: Proprietary Blend of Botanical Extracts; Participants consumed 2.4ml of the supplement each night before bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRI Sleep Scale	The NRI Sleep Scale is a validated measure of sleep health. It has 6 domains, each measured on a Likert scale, with higher scores indicating greater sleep disturbances.	From baseline to the end of the 28 day intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearable Technology	Sleep data sourced from the participant's Apple Watch (time in bed, time spent per phase (awake, REM, core, and deep).	From baseline to the end of the 28 day intervention.
NRI Energy Scale	Description: The NRI Energy Scale is a validated measure of fatigue. It has 7 domains, each measured on a Likert scale, with higher scores indicating greater fatigue.	From baseline to the end of the 28 day intervention.

Collaborators and Investigators

• Sponsor: Nutraceuticals Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: 24-05-500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No