Evaluating a botanical extract for improving 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

This study is testing a special blend of plant extracts to see if it can help women aged 35 to 55 sleep better compared to melatonin.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 35 Years to 55 Years
• Sex: Female
• Sponsor: Nutraceuticals Research Institute (Academic / other)
• Locations: 1 site (Huntsville, Alabama)
• Trial ID: NCT06894108 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of a proprietary blend of botanical extracts in enhancing sleep quality compared to melatonin in healthy female participants aged 35 to 55. Participants will be required to provide informed consent and comply with study procedures, including the use of an Apple Watch or similar device to monitor sleep patterns. The study will focus on women who self-report poor sleep quality and are in good general health, while adhering to specific lifestyle considerations throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 35 to 55 who experience poor sleep quality.

Not a fit: Patients who are pregnant, breastfeeding, or have been diagnosed with a sleep disorder in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural alternative to melatonin for improving sleep quality in women.

How similar studies have performed: While the specific approach of using this proprietary botanical extract is novel, similar studies evaluating natural sleep aids have shown varying degrees of success.

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

Where this trial is running

Huntsville, Alabama

• Nutraceuticals Research Institute — Huntsville, Alabama, United States (Recruiting)

Study contacts

• Study coordinator: JESSIE HAWKINS, PhD

Conditions Sleep