SleepNCT06894108
The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality
A study testing Proprietary Blend of Botanical Extracts and Melatonin in people with Sleep, run by Nutraceuticals Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Proprietary Blend of Botanical Extracts and Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Nutraceuticals Research Institute
Huntsville, Alabama, 35801
About this study
Official title: 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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Blend of Botanical ExtractsDietary supplement
Participants consumed 2.4ml of the supplement each night before bed.
MelatoninDietary supplement
Participants consumed 1mg melatonin each night before bed.
| Study group | Role | What they receive |
|---|---|---|
| Botanical Blend | Experimental | Not described Receives: Dietary Supplement: Proprietary Blend of Botanical Extracts |
| Comparison | Active comparator | Not described Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRI Sleep Scale
The NRI Sleep Scale is a validated measure of sleep health. It has 6 domains, each measured on a Likert scale, with higher scores indicating greater sleep disturbances.
Measured: From baseline to the end of the 28 day intervention.
Secondary outcomes (2)
Wearable Technology
Sleep data sourced from the participant's Apple Watch (time in bed, time spent per phase (awake, REM, core, and deep).
Measured: From baseline to the end of the 28 day intervention.
NRI Energy Scale
Description: The NRI Energy Scale is a validated measure of fatigue. It has 7 domains, each measured on a Likert scale, with higher scores indicating greater fatigue.
Measured: From baseline to the end of the 28 day intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Hawkins, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894108
- Sponsor's protocol ID
- 24-05-500
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06894108
- Acronym / sponsor ID
- 24-05-500
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botanical Blend | Experimental | Dietary Supplement: Proprietary Blend of Botanical Extracts |
| Comparison | Active comparator | Dietary Supplement: Melatonin |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprietary Blend of Botanical ExtractsParticipants consumed 2.4ml of the supplement each night before bed. | Dietary supplement | Botanical Blend |
| MelatoninParticipants consumed 1mg melatonin each night before bed. | Dietary supplement | Comparison |
Primary outcome
NRI Sleep Scale
Time frame: From baseline to the end of the 28 day intervention.
The NRI Sleep Scale is a validated measure of sleep health. It has 6 domains, each measured on a Likert scale, with higher scores indicating greater sleep disturbances.
2 secondary outcomes
Wearable Technology
Time frame: From baseline to the end of the 28 day intervention.
NRI Energy Scale
Time frame: From baseline to the end of the 28 day intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary Blend of Botanical Extracts and Melatonin in people with Sleep, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRI Sleep Scale (time frame: From baseline to the end of the 28 day intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.