| CTRI Number |
CTRI/2022/08/044862 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of Chewable Gummies for Sleep Deprivation. |
|
Scientific Title of Study
|
An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Chewable Gummies in Healthy Adult Subjects with Sleep Deprivation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B02406; Version: 01, Dated 05 Aug 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research,
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India |
|
|
Primary Sponsor
|
| Name |
Ikaria Wellness Pvt Ltd |
| Address |
412-B, The Capital,
Bandra Kurla Complex,
Mumbai – 400051
Maharashtra |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
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. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
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. Product will be taken once a day for duration of 25 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open
label, single arm, clinical study to evaluate efficacy and safety of Chewable
Gummies 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 (±2 days)
Visit 03: Evaluation Visit and End of Study (EOS)
i.e., Day 25 (±2 days) |