Status:
COMPLETED
The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality
Lead Sponsor:
Nutraceuticals Research Institute
Conditions:
Sleep
Eligibility:
FEMALE
35-55 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06894108
Start Date
October 1 2024
End Date
April 30 2025
Last Update
September 23 2025
Active Locations (1)
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1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801