A study of Chewable Gummies for Sleep Deprivation.

Completed

Conditions: Subjects with at least one sleep symptom and one wake symptom in past 6 months.Subjects with more than equal 42 score of Sleep Quality Scale (SQS) at screening visit.

Brief Summary: This is an openlabel, single arm, clinical study to evaluate efficacy and safety of ChewableGummies in healthy adult subjects with Sleep Deprivation.

Study will consist of total 03 visits.

Visit 01: Screening & Enrollment Visit, Day 01

Visit 02: Evaluation Visit i.e., Day 15 (Â±2 days)

Visit 03: Evaluation Visit and End of Study (EOS)i.e., Day 25 (Â±2 days)

Recruitment & Eligibility

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 â‰¥42 score of Sleep Quality Scale (SQS) at screening visit.

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.

Primary Outcome Measures

Name	Time	Method
changes in Sleep Quality Scale (SQS)	baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).

Secondary Outcome Measures

Name	Time	Method
changes in Cortisol levels	baseline i.e., Day 01 and after treatment on Day 25 (plus minus 2 days).
changes in Perceived Stress Scale (PSS) Questionnaire	baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).
changes in Daytime fatigue using Fatigue Severity Scale (FSS)	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 Index	baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days)
Skin radiance using Modified Griffiths Scale by Dermatologist	baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days)
Skin Glow by Skin Glossymeter GL 200	baseline i.e., Day 01 and after treatment on 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 questionnaire	baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).
Product perception	Day 15 (plus minus 2 Days) and Day 25 (plus minus 2 Days)

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@cliantha.com