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

NCT06894108 | Completed

• 1 other identifier: 24-05-500
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Wearable Technology

  From baseline to the end of the 28 day intervention.

• NRI Energy Scale

  From baseline to the end of the 28 day intervention.

Study Arms (2)

Botanical Blend

EXPERIMENTAL

Dietary Supplement: Proprietary Blend of Botanical Extracts

Comparison

ACTIVE COMPARATOR

Dietary Supplement: Melatonin

Interventions

Proprietary Blend of Botanical Extracts DIETARY_SUPPLEMENT

Participants consumed 2.4ml of the supplement each night before bed.

Botanical Blend

Melatonin DIETARY_SUPPLEMENT

Participants consumed 1mg melatonin each night before bed.

Comparison

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: Individuals who identify as female quality to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)