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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
32
1 Tablet daily half an hour before going to bed
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
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
Time frame: 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
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)
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
Time frame: 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
Time frame: 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
Time frame: Day 15 (post usage)
Subject treatment perception
To evaluate the effectiveness of test treatment in terms dependence and withdrawal symptoms by telephonic follow up
Time frame: Day 30 (post usage)
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Change in Complete Blood Count
To evaluate the effectiveness of test treatment in terms difference in Complete Blood Count
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Baseline Day 01 (before usage) and Day 15 (post usage)