Difficulty in Sleep InitiationNCT05853757
A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.
A study testing Zzowin Nutra Tablet in people with Difficulty in Sleep Initiation, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety, efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having difficulty in falling asleep. A total of up to 32 subject will be enrolled to get 30 completed subject in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficulty in Sleep Initiation
- What is being tested?
- Zzowin Nutra Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 17 Apr 2023to 30 May 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years (both inclusive) at the time of consent.
- Sex: Healthy non-pregnant/non-lactating females and males.
- Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
- Female of childbearing potential must a reported negative pregnancy test, agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- Subject is generally in good health.
- Subjects who having > 30 minutes to fall asleep and subjective total sleep time of is 6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep.
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- Habitual bedtime between 8.30 pm to midnight.
- Subject is willing to give written informed consent and are willing to follow the study procedure.
- Agree to comply with all study procedures
Who cannot join
- Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
- Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
- Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
- Subject who are using tobacco products during night awakenings.
- Subject with history of seizures or significant head trauma.
- Subject worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
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- Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
- Use of any:
- Prescribed or over-the-counter (OTC) anti-inflammatory or medicine that leads to overweight like corticosteroids drugs within five (5) days prior to dosing.
- Antihistamine medication/immunosuppressive drugs within seven (7) days before first dosing.
- Any other investigational drug was used within three months prior the entry in this study.
- Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Science/Concept Clinical Study With a Single-arm, Single-Blind to Evaluate Safety, Efficacy, and In-use Tolerability of Herbal Supplement in Healthy Adult Human Subjects Having Difficulty to Fall Asleep.
A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety, efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having difficulty in falling asleep.
A total of up to 32 subject will be enrolled to get 30 completed subject in the study.
Read the detailed description
A sufficient number of adult subjects with an age group of 18 - 65 years old will be recruited/enrolled.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day -07): Screening within 7 days from Day 01
- Visit 02 (Day 01): Enrolment Day
- Visit 03 (Day 15): End of treatment
- Visit 04 (Day 30): Telephonic follow-up Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) have to fill up the sleep diary before enrolment.
Assessment of safety and efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatment usage on Day 15 (+2 Days) as listed-below.
- Leeds Sleep Evaluation Questionnaire (LSEQ)
- Clinical examination - Scoring Based
- Sleep diary (sleeping time, the time interval in getting sleep, sleep interruptions, wake-up time, naps during the day, feeling, irritability, total duration of sleep, sleep quality.
- Product perception questionnaires (Product's effectiveness, likeliness and overall satisfaction- Hedonic scale (0-9-point scale)
- Blood parameter (CBC, ESR, RBS, SGOT, SGPT, S. Creatinine) - Safety Labs
- Conditions
- Difficulty in Sleep Initiation
- Being tested
- Zzowin Nutra Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zzowin Nutra TabletDrug
Also called Herbal Supplement
1 Tablet daily half an hour before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Zzowin Nutra Tablet | Experimental | Zzowin Nutra Tablet contains Melatonin, Tagar, L-theanine, L-Tryptophan, vitamin B6, Iron, Zinc, and Magnesium. which is helpful to provide deep, calm, and restful sleep. Receives: Drug: Zzowin Nutra Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of sleep
To evaluate the effectiveness of test treatment in terms of change in quality of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate Easier than usual
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in duration sleep
To evaluate the effectiveness of test treatment in terms of change in duration of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate easier than usual
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Secondary outcomes (10)
Change in sleep quality by subjective self evaluated
To assess the effectiveness of test treatment in terms of change in sleep quality by using subjective Sleep diary
Measured: From Day -7 (before usage) and Day 15 (post usage)
Improvement in overall health and wellbeing
To assess the effectiveness of test treatment in terms Improvement in overall health and wellbeing by clinical examination
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Subject product perception questionnaire
To evaluate the effectiveness of test treatment in terms of subject perception Questionnaire by using 9-point hedonic scale in which1 indicate extremely ineffective to 9 indicate extremely effective
Measured: Day 15 (post usage)
Subject treatment perception
To evaluate the effectiveness of test treatment in terms dependence and withdrawal symptoms by telephonic follow up
Measured: Day 30 (post usage)
Change in Complete Blood Count
To evaluate the effectiveness of test treatment in terms difference in Complete Blood Count
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Erythrocyte Sedimentation Rate
To evaluate the effectiveness of test treatment in terms difference in Erythrocyte Sedimentation Rate
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Random Blood Sugar
To evaluate the effectiveness of test treatment in terms difference in Random Blood Sugar
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Glutamate Pyruvate Transaminase
To evaluate the effectiveness of test treatment in terms difference in Serum Glutamate Pyruvate Transaminase
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Glutamate Oxaloacetic Transaminase
To evaluate the effectiveness of test treatment in terms difference in Serum Glutamate Oxaloacetic Transaminase
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Creatinine
To evaluate the effectiveness of test treatment in terms difference in Serum Creatinine
Measured: From Baseline Day 01 (before usage) and Day 15 (post usage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start17 Apr 2023
- Primary completion23 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulty in Sleep InitiationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of science/concept, Single-arm, Single-blind
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Vedistry Private Limited
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr. Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853757
- Sponsor's protocol ID
- NB230006-VPL
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2023
- Last updated
- 10 Jul 2023
- 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 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Science/Concept Clinical Study With a Single-arm, Single-Blind to Evaluate Safety, Efficacy, and In-use Tolerability of Herbal Supplement in Healthy Adult Human Subjects Having Difficulty to Fall Asleep.
- ClinicalTrials.gov ID
- NCT05853757
- Acronym / sponsor ID
- NB230006-VPL
- Conditions
- Difficulty in Sleep Initiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Vedistry Private Limited
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 May 2023 (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.
A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety, efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having difficulty in falling asleep.
A total of up to 32 subject will be enrolled to get 30 completed subject in the study.
Detailed description
A sufficient number of adult subjects with an age group of 18 - 65 years old will be recruited/enrolled.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day -07): Screening within 7 days from Day 01
- Visit 02 (Day 01): Enrolment Day
- Visit 03 (Day 15): End of treatment
- Visit 04 (Day 30): Telephonic follow-up Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) have to fill up the sleep diary before enrolment.
Assessment of safety and efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatment usage on Day 15 (+2 Days) as listed-below.
- Leeds Sleep Evaluation Questionnaire (LSEQ)
- Clinical examination - Scoring Based
- Sleep diary (sleeping time, the time interval in getting sleep, sleep interruptions, wake-up time, naps during the day, feeling, irritability, total duration of sleep, sleep quality.
- Product perception questionnaires (Product's effectiveness, likeliness and overall satisfaction- Hedonic scale (0-9-point scale)
- Blood parameter (CBC, ESR, RBS, SGOT, SGPT, S. Creatinine) - Safety Labs
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of science/concept, Single-arm, Single-blind
| Arm | Type | Receives |
|---|---|---|
| Zzowin Nutra Tablet | Experimental | Drug: Zzowin Nutra TabletZzowin Nutra Tablet contains Melatonin, Tagar, L-theanine, L-Tryptophan, vitamin B6, Iron, Zinc, and Magnesium. which is helpful to provide deep, calm, and restful sleep. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 to 65 years (both inclusive) at the time of consent.
- Sex: Healthy non-pregnant/non-lactating females and males.
- Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
- Female of childbearing potential must a reported negative pregnancy test, agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- Subject is generally in good health.
Key exclusion criteria (15 listed)
- Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
- Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
- Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
- Subject who are using tobacco products during night awakenings.
- Subject with history of seizures or significant head trauma.
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 |
|---|---|---|
| Zzowin Nutra TabletAlso: Herbal Supplement1 Tablet daily half an hour before going to bed | Drug | Zzowin Nutra Tablet |
Primary outcome
Change in quality of sleep
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
To evaluate the effectiveness of test treatment in terms of change in quality of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate Easier than usual
Change in duration sleep
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
To evaluate the effectiveness of test treatment in terms of change in duration of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate easier than usual
10 secondary outcomes
Change in sleep quality by subjective self evaluated
Time frame: From Day -7 (before usage) and Day 15 (post usage)
Improvement in overall health and wellbeing
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Subject product perception questionnaire
Time frame: Day 15 (post usage)
Subject treatment perception
Time frame: Day 30 (post usage)
Change in Complete Blood Count
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Erythrocyte Sedimentation Rate
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Random Blood Sugar
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Glutamate Pyruvate Transaminase
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Glutamate Oxaloacetic Transaminase
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Change in Serum Creatinine
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
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 10 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Dr. Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zzowin Nutra Tablet in people with Difficulty in Sleep Initiation, run by NovoBliss Research Pvt Ltd at 1 site in India.
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 9 inclusion and 15 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 10 Jul 2023. 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 India. 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?
Change in quality of sleep (time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)). The study lists 2 primary outcomes in all. 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 10 Jul 2023.