Clinical trial NCT05853757: A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficulty in Sleep Initiation
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Vedistry Private Limited
First posted: 2023-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of science/concept, Single-arm, Single-blind
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 65 years (both inclusive) at the time of consent.
2. Sex: Healthy non-pregnant/non-lactating females and males.
3. Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
4. 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.
5. Subject is generally in good health.
6. 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.
7. Habitual bedtime between 8.30 pm to midnight.
8. Subject is willing to give written informed consent and are willing to follow the study procedure.
9. Agree to comply with all study procedures

Exclusion Criteria:

1. Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
2. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
3. Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
4. Subject who are using tobacco products during night awakenings.
5. Subject with history of seizures or significant head trauma.
6. 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.
7. Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
8. Use of any:

   (i) Prescribed or over-the-counter (OTC) anti-inflammatory or medicine that leads to overweight like corticosteroids drugs within five (5) days prior to dosing.

   (ii) Antihistamine medication/immunosuppressive drugs within seven (7) days before first dosing.
9. Any other investigational drug was used within three months prior the entry in this study.
10. Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent
11. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
12. Pregnant or breastfeeding or planning to become pregnant during the study period.
13. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks.

Primary outcomes:
measure: Change in quality of sleep
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in duration sleep
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Secondary outcomes:
measure: Change in sleep quality by subjective self evaluated
timeFrame: From Day -7 (before usage) and Day 15 (post usage)
measure: Improvement in overall health and wellbeing
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Subject product perception questionnaire
timeFrame: Day 15 (post usage)
measure: Subject treatment perception
timeFrame: Day 30 (post usage)
measure: Change in Complete Blood Count
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in Erythrocyte Sedimentation Rate
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in Random Blood Sugar
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in Serum Glutamate Pyruvate Transaminase
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in Serum Glutamate Oxaloacetic Transaminase
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
measure: Change in Serum Creatinine
timeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: Medical Director
name: Dr. Nayan K Patel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: