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

NCT ID: NCT06894108

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Botanical Blend

Group Type: EXPERIMENTAL

Proprietary Blend of Botanical Extracts

Intervention Type: DIETARY_SUPPLEMENT

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

Comparison

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Participants consumed 1mg melatonin each night before bed.

Interventions

Proprietary Blend of Botanical Extracts

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

Intervention Type: DIETARY_SUPPLEMENT

Melatonin

Participants consumed 1mg melatonin each night before bed.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nutraceuticals Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Jessie Hawkins

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nutraceuticals Research Institute

Huntsville, Alabama, United States

Countries

United States

Other Identifiers

24-05-500

Identifier Type: -

Identifier Source: org_study_id