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

Nutraceuticals Research Institute

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: Proprietary Blend of Botanical Extracts; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT06894108

24-05-500

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

89 participants in 2 patient groups

Botanical Blend

Experimental group

Treatment:

Dietary Supplement: Proprietary Blend of Botanical Extracts

Comparison

Active Comparator group

Treatment:

Dietary Supplement: Melatonin