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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a blend of botanical extracts in improving sleep quality compared to melatonin. It focuses on women in generally good health who have experienced poor sleep. The study includes two groups: one will take the proprietary blend of botanical extracts, and the other will take melatonin to determine which is more effective. Women who may be suitable for this trial have trouble sleeping and wear an Apple Watch or similar device. As an unphased trial, it offers participants the chance to explore alternative sleep aids and contribute to valuable research on sleep improvement.

Will I have to stop taking my current medications?

The trial requires that you do not consume any sleep aids, medications, diets, or supplements intended to improve sleep. If you are taking any of these, you will need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the safety of plant-based extracts for sleep can vary. One study found that a specific mix of plant extracts was safe for short-term use and could serve as an alternative to prescription sleep aids like zolpidem. However, another source noted that California poppy, a common ingredient in sleep aids, might have effects similar to opioids, so caution is advised for some individuals. Additionally, some plant extracts can cause side effects such as increased anxiety or heart palpitations, particularly in people with conditions like bipolar disorder.

While some blends show promise, the complete safety of each plant combination may not be fully understood. Considering these factors and consulting healthcare providers is important when contemplating participation in trials involving plant extracts. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Botanical Extracts + Melatonin treatment for sleep because it combines a proprietary blend of natural botanical extracts with melatonin, offering a unique approach to improving sleep quality. Unlike conventional sleep aids that often rely on synthetic compounds or pharmaceuticals, this treatment uses natural ingredients that may reduce the risk of side effects. Additionally, the blend is designed to enhance melatonin's natural sleep-inducing effects, potentially providing a more holistic and gentle solution for those struggling with sleep issues.

What evidence suggests that this trial's treatments could be effective for improving sleep quality?

This trial will compare a proprietary blend of botanical extracts with an active comparator. Research has shown that a special mix of plant extracts can improve sleep. One study found that this mix helped people sleep longer and more soundly. Another study showed that participants fell asleep more easily and experienced better overall sleep quality compared to those who received a placebo. People with mild sleep problems also reported better sleep and fewer insomnia symptoms. Although some results were modest, these studies suggest that the plant mix might help improve sleep. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 often have trouble sleeping well.

I am biologically female and identify as a woman.

Has an apple watch or similar device

Exclusion Criteria

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

I have been diagnosed with sleep apnea or narcolepsy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8000032/

A Randomized, Double-Blind, Placebo-Controlled Trial of a ... Despite the null findings for sleep onset latency and percent REM sleep, the use of PBB resulted in modestly improved sleep quality, sustained ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2225411019302391

A combination of Eschscholtzia californica Cham. and ... Night sleep duration significantly increased between the first and the fourth week of supplement intake, sleep efficiency increasing from 78.4% ± 12.5 to 84.6% ...

3. sleep.biomedcentral.com sleep.biomedcentral.com/articles/10.1186/s41606-024-00122-7

Assessment of a multi-ingredient dietary supplement on sleep ... Results. Study supplement significantly improved sleep quality of participants compared to placebo group, specifically difficulty falling asleep ...

4. researchgate.net researchgate.net/publication/350112479_A_Randomized_Double-Blind_Placebo-Controlled_Trial_of_a_Polyphenol_Botanical_Blend_on_Sleep_and_Daytime_Functioning

A Randomized, Double-Blind, Placebo-Controlled Trial of ... Among individuals with subclinical sleep disturbances, PBB improved sleep quality, insomnia severity, and neurocognitive functioning over placebo. These ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06894108

The Effectiveness of a Proprietary of a Botanical Extract on ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3608291/

Efficacy and safety of a polyherbal sedative-hypnotic ... Conclusions: NSF-3 is a safe and effective short-term alternative to zolpidem for primary insomnia. It remains to be explored whether the benefits are sustained ...

7. va.gov va.gov/WHOLEHEALTHLIBRARY/tools/botanical-medicines-healthy-sleep-rest.asp

Botanical Medicines to Support Healthy Sleep and Rest Side effects include agitation, insomnia, increased anxiety and palpitations. Because Rhodiola is mildly stimulating it should be used with caution in bipolar ...