Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT05853757
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: