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Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

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Studies 94
Trials 51
Completed NA INTERVENTIONAL NCT05853757

A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.

View on ClinicalTrials.gov Updated Dec 15, 2025

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

Interventions

Name: Zzowin Nutra Tablet
Type: DRUG
Description: 1 Tablet daily half an hour before going to bed

Primary Outcomes

Measure: Change in quality of sleep
TimeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Description: 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
Measure: Change in duration sleep
TimeFrame: From Baseline Day 01 (before usage) and Day 15 (post usage)
Description: 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

Trial Information

NCT ID

NCT05853757

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

NovoBliss Research Pvt Ltd

Last Updated

December 15, 2025