None listed
Conditions
Interventions
Intervention1: Nyumi Beauty Sleep Gummies: Subjects will be instructed to simply chew and swallow 2 gummies together after dinner. Ensure that the gummies are taken half to 1 hour before sleeping. Pro
Sponsors
Ikaria Wellness Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects willing to follow usual wake sleep schedule during the study period. 2.Subjects with atleast one sleep symptom and one wake symptom in past 6 months: A.Sleep symptom: Difficulty initiating/ maintaining sleep, Early morning awakening, Non restorative or non refreshing sleep or insomnia. B.Wake symptom: comprising of sleep associated day time impairment e.g. sleepiness, fatigue, mood disturbances, cognitive difficulties, social impairment or occupational impairment. 3.Subjects with >=42 score of Sleep Quality Scale (SQS) at screening visit.
Exclusion criteria
Exclusion criteria: 1.Subjects having sleep schedule changes associated with shift work. 2.Subjects on any medications or supplements known to affect sleep-wake function must not have been taken within 2 weeks prior to enrollment. 3.Subjects with a history of sleep apnea, chronic obstructive pulmonary disease, seizures, anxiety, depression, schizophrenia, bipolar disorder, mental retardation, a cognitive disorder, disturbance in sleep due to snoring, etc. 4.Subjects with history of drug addiction or abuse within 12 months of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in Sleep Quality Scale (SQS)Timepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in Cortisol levelsTimepoint: baseline i.e., Day 01 and after treatment on Day 25 (plus minus 2 days).;changes in Daytime fatigue using Fatigue Severity Scale (FSS)Timepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).;changes in Perceived Stress Scale (PSS) QuestionnaireTimepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).;changes in Severity of Insomnia using Insomnia Severity IndexTimepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days);Product perceptionTimepoint: Day 15 (plus minus 2 Days) and Day 25 (plus minus 2 Days);Skin Glow by Skin Glossymeter GL 200Timepoint: baseline i.e., Day 01 and after treatment on Day 25 (plus minus 2 days);Skin radiance using Modified Griffiths Scale by DermatologistTimepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days);To assess the effect of test product on changes in Subject-reported total sleep time, Sleep latency, Sleep efficiency (Total sleep time or time in bed into 100), Subject-reported time to sleep onset, Subject- reported number of awakenings, Subject -reported wake time after sleep onset, daytime mood, ability to function at work, concentration and memory, skin glow by subjective assessment questionnaireTimepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days). | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed