Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT05853757
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
Study:
NCT05853757
Study Brief:
Protocol Section:
NCT05853757