Botanical Extracts + Melatonin for Sleep

Overseen By JESSIE HAWKINS, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Nutraceuticals Research Institute

Must not be taking: Sleep aids

Disqualifiers: Pregnancy, Smoking, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

88 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for healthy women aged 35-55 with self-reported poor sleep quality, who can follow the study procedures and use effective contraception. They must own an Apple Watch or similar device and agree to lifestyle guidelines. Exclusions include night shift workers, those with certain sleep disorders, heavy alcohol users, smokers/vapers within a year, recent dramatic weight changes, primary caretakers of young children, and anyone on other sleep aids.

Inclusion Criteria

I am willing and able to follow the study's requirements.

Has an apple watch or similar device

I often have trouble sleeping well.

Exclusion Criteria

Works a night shift, is 'on-call' or performs any job requiring or potentially requiring work related responsibilities after 8pm

I have been diagnosed with sleep apnea or narcolepsy.

Consumes > 8 alcoholic beverages in an average week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the botanical based sleep product or melatonin for sleep quality improvement

4 weeks

Baseline and end of treatment visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Proprietary Blend of Botanical Extracts

Trial Overview The study aims to compare the effectiveness of a proprietary blend of botanical extracts against melatonin in improving sleep quality among female participants. Each participant will receive either the botanical product or melatonin over the course of the study to determine which one leads to better sleep outcomes.

Participant Groups

Group I: Botanical Blend Experimental Treatment 1 Intervention

Group II: Comparison Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nutraceuticals Research Institute

Lead Sponsor

Trials

19

Recruited

3,700+